Background and Identification
The Vitalograph Alpha is a portable desktop spirometer with an integrated printer. This device can be used to test lung function in both adult and pediatric patients. Users can operate the Alpha without a computer. Newer versions of the Alpha come with software that allows users to create PDF reports of test results. Vitalograph has produced the Alpha since the 1980's, and the device often remains operable for ten years or more. It is sold internationally.
The Vitalograph Alpha is the size of a large book (about 12 x 10 x 3 inches) and weighs about 5 pounds. It has a handle for carrying, a screen for viewing real-time data, and 12 buttons for inputting information.
In 2010, Vitalograph started producing the Alpha Touch in addition to the Alpha. The Alpha Touch has a touch screen and fewer buttons. This device page is for the Alpha, not the Alpha Touch.
Sources: Vitalograph Alpha Page, Vitalograph News, and Vitalograph Timeline.
Technical Specifications
Dimensions: 300 x 250 x 75mm
Weight: 2kg net
Operating Temperature Range:
ATS Limits: 17-37°C
Design Limits: 10 - 40°C
Voltage/Frequency: 110 - 250V~50/60Hz
Flow Detection Principle: Fleisch type pneumotachograph
Volume Detection: Flow Integration sampling @ 100Hz
Accuracy when in Operating Range:
Flow +/- from 10% to 5%
Max flow rate +/-16L/s
Min flow rate +/-0.02L/s
Volume Accuracy: Better than +/-3%
Maximum Displayed Volume: 10L
Maximum Test Duration: 90 seconds
Flow Impedance:
0.1kpa L/s @ 14L/s
Complies with ATS/ERS 2005
Printer: Thermal
Performance Standards:
ATS/ERS 2005
ISO 26782:2009
ISO 23747:2007
Safety Standards: IEC 60601-1:2005
Medical Safety Standard:
Medical Devices Directive
93/42/EEC as amended
Designed & Manufactured Under:
ISO 13485:2003 and 2016
FDA 21 CFR 820
CMDR
Communications: USB and Compact Flash
Source: Vitalograph Alpha Specification
Additional Information
Vitalograph Alpha Instructions for Use