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DT_0006 Issue 15
A Global Leader in Respiratory Solutions
memory card or to internal memory for later playback, review, and
analysis of the cough sounds on a windows based PC.
The VitaloJAK is intended for use by technicians who are trained in
the operation of Cough Recording Sessions. The VitaloJAK is not
interpretative and it does not deliver a diagnosis. The VitaloJAK is
not life supporting equipment, it does not screen, treat or prevent
any condition or disease. It is intended to acquire, record and
store ambulatory cough sounds from patients for up to 24 hours.
The device stores the data to internal memory or to a removable
memory card for later playback, review, and analysis of the cough
sounds on a windows based PC. The subjects may be of any user
population, weight range, health or condition.
12.
Technical Specification
Product
VitaloJAK
Model
7100
Essential Performance
Recording the audio inputs from the
Cough Sensor and Microphone
Essential Performance
Test Limits
Recordings are downloaded to a PC for
subsequent analysis by trained Audio
Analysts. A valid sound recording must
be present on one of the channels
(either Cough Sensor or Microphone)
to perform audio analysis. Minimum
requirement for a valid audio file for
EN60601 testing is no flat line data,
indicating no audio was recorded.
Safety Standards
EN 60601-1:2006+A1:2013
Home Healthcare
Standard
EN 60601-1-11:2015
EMC Standards
EN 60601-1-2:2015
QA/GMP Standards
EN ISO 13485, CMDR SOR/98-282 &
FDA 21 CFR 820
Содержание VitaloJAK 7100
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