Safety; Intended Use; Indications For Use - Sibelmed DATOSPIR AIRA Manual De Uso

DATOSPIR
· User's Manual

1. SAFETY

DATOSPIR
is a hand held computerized spirometer that measures the volume and
flow of air inspired and expired from the patient's lungs.
DATOSPIR
has been designed for maximum safety. The complete use instructions
should be read before proceeding to operate with the system. Failure to do so may result
in injuries to the user or the patient and damage to the device and/or accessories.
Contact with SIBEL, S.A.U. or your dealer for more information about the technique or the
product.

1.1 INTENDED USE

Measurement of lung flows and volumes for the diagnostic and control of respiratory diseases
(Asthma, COPD, etc.).
The following conditions must be considered:
- Intended for indoor use (not for outdoor use).
- Intended for use in a health center or similar.
- Not intended for use in moving transport vehicles.

1.2 INDICATIONS FOR USE

Spirometry is the most common of the Pulmonary Function Tests and allows the measurement
of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled by a
subject. Spirometry is a helpful tool for assessing medical conditions such as asthma,
pulmonary fibrosis, cystic fibrosis, and Chronic Obstructive Pulmonary Disease (COPD).
DATOSPIR
The spirometer works in conjunction with an external software application
(for example W20s). When the subjects blows through the transducer (Turbine, Fleisch or
Disposable), the device acquires the flow signal and sends it via USB or Bluetooth to the
software. The software application calculates spirometric parameters from the acquired
flow samples.
511-D00-MUM · Rev 1.01
EN 4