Title:
DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE
DCO#:
00271
Document#:
870-00001-01
Originating Author:
E Keate
Modifying Author:
R. Massie
Date Created:
9/04/2018
Date Modified:
05/28/2020
Revision:
AR
Page
97 of 175
The BTPS entry screen appears when the Spirometer test is initiated.
The
animation indicates that the BAR 228 is active and entering BTPS.
3. Review the BTPS values from the BAR 228 that appear on the BTPS screen.
4. If the BAR 228 is unavailable, manually determine and enter BTPS values:
•
Ensure BTPS entry is set to Manual in the Spirometer Settings.
•
Determine BTPS per the following requirements: Check the Barometric Pressure, Temperature,
and Humidity of the IDM100 Medical Tablet
’s location and enter these values into the BTPS fields.
Enter barometric pressure as given by a barometer in the immediate vicinity. Do not enter the
normalized sea-level pressure as commonly listed on internet sites on meteorological data
resources.
•
Enter BTPS in Spirometer Settings:
o
At least once daily (the IDM100 Medical Tablet will request that you enter the BTPS values
every 24 hours).
o
When atmospheric conditions have changed.
o
When the IDM100 Medical Tablet location has changed.
14.4 Spirometer Test
Administration of spirometry must be performed by a health care professional present with the
patient. Spirometry tests are not to be administered by a patient. The HCP performing the
spirometry test should have had prior training in spirometric measurements.
A device-generated assessment cannot replace sound medical judgement by a trained
professional. Therefore, a physician should always review the spirometry results. To minimize
the chance of a misdiagnosis, it is the
physician’s responsibility to assure that spirometry tests
are properly administered, evaluated, and interpreted.
Use the Spirometer only if it passes the Spirometer Calibration Check. See section 21.5
Spirometer Calibration Check. Otherwise, measurements could be inaccurate and
could result in a misdiagnosis.