Vitalograph ALPHA Touch - 11 Description of the ALPHA Touch; Indications for Use; 12 Technical Specification

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DT_0006 Issue 15
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11. Description of the ALPHA Touch
The Vitalograph ALPHA Touch is a spirometer which measures subject
respiratory parameters including but not limited to VC, FVC, FEV1, PEF and
MVV. It is designed for desktop use. The Fleisch owhead is used for testing
and has a resting location on the device.
11.1. Indications for Use
The indications for use of the Vitalograph ALPHA Touch is in the assessment
of lung function through the measurement of dynamic lung volumes, i.e.
spirometry.
The ALPHA Touch is designed to be operated by medical professionals trained
in respiratory and lung function testing on adults and paediatrics, 2.5 years and
older, in a variety of professional healthcare environments, e.g. primary care,
hospitals and occupational health centres. The measurements obtained from
a lung function test provide objective information used in the diagnosis of lung
diseases and monitoring lung health.
12. Technical Specication
Product
Vitalograph ALPHA Touch, Model 6000
Flow Detection Principal
Fleisch type pneumotachograph
Volume detection
Flow integration sampling @ 100Hz
Maximum test duration
90 seconds
Maximum displayed
volume
10 L