TESTS TO PERFORM AFTER POSITIVE RESULTS ARE OBTAINED FROM PREVIOUS TESTS
SPIROMETRY TEST
This test must be carried out as follows:
a) Measure the ambient temperature using a digital thermometer and check that the BTPS value corresponds to
the value in Table 3, the same temperature in the testing room.
b) Fill in the FIVC nom (L) (min and max) fields of the SPIROMETRY TEST (Annex 1), min and max
nominal values of current BTPS, from Table 3 below.
c) Check that the stop of the 3 L calibration syringe is at “3.0”.
d) Move the piston of the syringe so that the “0.0” of the calibrated shaft is positioned with the shaft exit.
e) Connect the device with a mouthpiece to the calibration syringe.
f) Make the FVC test.
g) Push the piston at a constant rate until the “3.0” of the calibrated shaft is positioned with the shaft exit.
h) Pull back the piston at the same rate as at letter (f) until the “0.0” of the calibrated shaft is positioned with
the shaft exit.
i) Push the piston until the “1.0” of the calibrated shaft is positioned with the shaft exit (0.5 L tolerance limit).
j) Read the FVC, FIVC and 2575 measured values to enter the FVC, FIVC measured values in the proper field
of the SPIROMETRY TEST (Annex 1 of this Manual).
k) If the values given by the device are not within the set min and max volumes, analyze and resolve the
problem, if there is no solution then the product must be identified as nonconforming.
At the end of the tests, the table contained in Annex 1
shall be completed.
The FVC (L) (min and max) nominal values contained
in the SPIROMETRY TEST (Annex 1) are already
inserted because the BTPS expiration factor is
constant and equal to 1.026 (corresponding to 37°C,
that is, the average body temperature).
At the end of the tests, where there are no negative
results, the device is identified as conforming and can
be returned to the user.
OXIMETRY TEST
This test must be performed using the following
instruments:
a) Device used to simulate oxygen saturation
b) The device to be tested
c) The device cable
The testing procedure is as follows:
a) Connect the sensor cable to the MIR device using
the proper connector.
b) Connect the sensor to the oximetry simulator
ensuring the correct positioning as shown in the
following image.
c) Set the oximetry value on the simulator at 85%
and BPM at 40.
d) Launch the oximetry test on the MIR device (see
User Manual).
e) Read the value given by the spirodoc (it must be
between 83 and 87%).
Table 3
FIVC min/max values, temperature or BTPS function
TEMPERATURA
AMBIENTE (C°)
FIVC min FIVC max
10 1,160 3,48 3,36 3,60
11 1,550 3,46 3,34 3,58
12 1,151 3,45 3,33 3,57
13 1,147 3,44 3,32 3,56
14 1,142 3,42 3,30 3,54
15 1,138 3,41 3,29 3,53
16 1,133 3,39 3,27 3,51
17 1,129 3,38 3,26 3,50
18 1,240 3,37 3,25 3,49
19 1,120 3,36 3,24 3,48
20 1,115 3,34 3,22 3,46
21 1,111 3,33 3,21 3,45
22 1,106 3,31 3,19 3,43
23 1,101 3,3 3,18 3,42
24 1,097 3,29 3,17 3,41
25 1,092 3,27 3,16 3,38
26 1,087 3,26 3,15 3,37
27 1,082 3,24 3,13 3,35
28 1,078 3,23 3,12 3,34
29 1,073 3,21 3,10 3,32
30 1,068 3,2 3,09 3,31
31 1,063 3,18 3,07 3,29
32 1,058 3,17 3,06 3,28
33 1,053 3,15 3,04 3,26
34 1,048 3,14 3,03 3,25
35 1,043 3,12 3,01 3,23
36 1,038 3,11 3,00 3,22
37 1,033 3,09 2,98 3,20
38 1,028 3,08 2,97 3,19
39 1,023 3,07 2,96 3,18
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