Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
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Page 69 of 78 DT_0006-15
Storage Temperature Limit
Storage Relative Humidity Limits
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11 Description of the Vitalograph Spirotrac
Vitalograph Spirotrac is a Windows based PC spirometry software designed for lung
function testing in a variety of professional healthcare environments. In addition to
spirometry testing, Spirotrac also includes Pulse Oximetry, Challenge Testing, Blood
Pressure, Six Minute Walk Test, 12-lead ECG and Audiometry modules.
In a clinical setting, the measurements obtained from a lung function test form part of
the various findings of a physician in the detection, diagnosis and control of chest
diseases. Spirometry may support or exclude diagnosis, but it cannot make one.
Spirometers are also used in non-clinical settings such as occupational health
screening where no clinical judgment is made, suspect findings leading to a referral to
a clinician. The software is intended for use by medical professionals trained in
respiratory and lung function testing as well as ECG and Audiometry. Apart from this
instruction manual, there are no other training requirements for the medical
professional.
Spirotrac communicates with the Vitalograph Pneumotrac, Vitalograph In2itive,
Vitalograph Alpha, Vitalograph Alpha Touch, Vitalograph 2120, Vitalograph 2160, Gold
Standard, Intrac and asma-1 Spirometry devices.
11.1 Indications for Use
Vitalograph Model 7000 Spirotrac is intended for use by, or on the order of, a
physician in a hospital or clinic setting. The product is designed for use on both adult
and paediatric subjects. The device is a PC based software application intended to be
used as a spirometer or connect to compatible devices to acquire, view, store and print
the device output.
12 Technical Specification
ATS/ERS 2005, ISO 23747:2007 & ISO
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