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S1-EN Spirometry v2.1
S1-EN Spirometry v2.1
S1-EN Spirometry v2.1
Version 2.1
S1-EN 14/05/2019
Content
1 Foreword .................................................................................................................. 5
2 General information .................................................................................................. 6
2.1 Description of test and application range ................................................................... 6
2.2 Indications ................................................................................................................... 6
2.3 Contraindications......................................................................................................... 7
3 Preparation of the testing .......................................................................................... 9
3.1 Preparing the equipment ............................................................................................ 9
3.2 Preparing the patient................................................................................................. 10
3.3 Encoding the patient in the database ....................................................................... 11
3.3.1 If the patient already exists in the database ............................................................................... 11
3.3.2 If the patient does not exist yet in the database ........................................................................ 12
3.4 Initializing the spirometry testing mode ................................................................... 13
4 Slow spirometry testing ........................................................................................... 16
4.1 Performing the test ................................................................................................... 16
4.2 Quality control ........................................................................................................... 18
4.3 Reviewing the test ..................................................................................................... 19
4.4 Editing the test........................................................................................................... 20
5 Forced spirometry testing ........................................................................................ 21
5.1 Performing the test ................................................................................................... 21
5.2 Quality control ........................................................................................................... 24
5.3 Reviewing the test ..................................................................................................... 25
5.4 Editing the test........................................................................................................... 26
5.4.1 Curves edition ............................................................................................................................. 26
5.4.2 Toolbox ....................................................................................................................................... 27
6 Maximum voluntary ventilation testing ................................................................... 28
6.1 Performing the test ................................................................................................... 28
6.2 Quality control ........................................................................................................... 29
6.3 Reviewing the test ..................................................................................................... 30
7 Minute tidal ventilation testing ............................................................................... 31
7.1 Performing the test ................................................................................................... 31
7.2 Quality control ........................................................................................................... 32
7.3 Reviewing the test ..................................................................................................... 33
1
This document provides instructions required to perform a spirometry test (slow and forced
expiratory capacity measurements) on Expair.
Spirometry option in Expair is a module to record and analyze the vital capacity and forced
expiratory flow rates. The interface is friendly to use. It provides a sensible spirogram
recorder and other functions for editing and printing the result. The spirometry is a basic
option for most the Medisoft instruments (Micro 5000, Micro 6000, HypAir, SpiroAir,
BodyBox), it allows to measure all the lung volumes that can be mobilized, including tidal
volume, functional reserve capacity, inspiratory capacity, vital capacity. In addition, the most
widely used pulmonary function test: the forced vital capacity maneuver is also ensured.
The purpose of this document is to help in using and putting your Medisoft equipment into
service. Please read this manual carefully before using the equipment for the first time. All
the necessary measurements must be taken in order to ensure safe use of the equipment.
This document is based on the last version (1.32) of our Expair software. Medisoft S.A.
reserves the right to modify the software or issue updates without prior notice. Therefore,
some differences could exist between these directions for use and the last version of the
software in use. Beware that some items may be modified slightly in last version of the
software.
2
2.1 Description of test and application range
Spirometry is a physiological measure of breath. This test aims to evaluate inspiratory and
expiratory flowrates, as well as lung volume subcomponents. Through spirometry outcomes,
pulmonary function abnormalities could be classified into two mains categories: obstructive
and restrictive patterns. This clinical approach is based on the fact that the test measures
two basic components – air flow (FEV1, FEF25-75, FEV6, …) and lung volume (SVC, FVC, IC,
…). Intermediate flowrates such as FEF25% or FEF50% might also reflect the dysfunction in
small airways.
Spirometry also includes two supplementary methods in which the spirometry exam is
repeated on a subject following the administration of a bronchodilator medication
(reversibility testing) or stimulating agents (bronchial provocation testing), in order to
distinguish COPD from asthma. This technique is totally non-invasive, therefore would not
raise any question about patient safety.
According to official guidelines, spirometry is the fundamental test for making a confident
diagnosis of obstructive airways disorders (e.g. COPD, asthma) and the most effective way
for determining the severity of lung diseases and following up. Spirometry is also a powerful
tool for screening of lung diseases in epidemiological studies.
2.2 Indications
The spirometry testing (including FVC and VC maneuvers) can be indicated:
2
abdominal aneurysms, cerebral aneurysms, recent eye surgery (within 2 weeks due to
increased intraocular pressure during forced expiration), recent abdominal or thoracic
surgical procedures, and patients with a history of syncope associated with forced
exhalation.
2
Hemoptysis or oral bleeding procedures.
Inability to follow directions In some cases, successful spirometry can
(eg, confusion, dementia, be obtained with increased coaching and
young age, language barrier) aid of an interpreter.
3
The module should be turned on at least 20 minutes before performing the
calibration and the first test.
This allows the warmup of the device.
2A Open fully each gas cylinder by rotating counter clock wise the tap.
Check the fill in pressure of each gas cylinder.
2B It should be at least 20 bars (290 psi). If lower pressure, replace the
cylinder.
Check the output pressure of the reducer of each gas cylinder. It should
2C
be set to 3.5 bars (50 psi) or 4.5 bar (65 psi) depending on your device.
Check the validity date of each gas cylinder (indicated on the analyse
2D certificate of the cylinder). Replace the cylinders which are no longer
valid.
Verify the device has been calibrated before in the day.
3
Read the chapter about calibration in the Hardware User Manual.
2 Install the patient seated upright with feet firmly on the floor in front of the
device. This is a safety precaution as the subject can become light headed during
3
the test and this can promote his falling from the chair, this posture minimises
any possible risk.
3 Adjust the arm and patient valve to the height of the subject’s mouth in the
normal seated position. The subject’s chest frame should be undistorted and the
diaphragm in a normal position.
4 Put a new single use barrier filter, and optionally a mouthpiece on the front of
the pneumotachograph. Instruct the patient in the correct use of the mouthpiece
and nose clip during the testing.
5 Instruct the patient in the performance of the test. Use simple words for him to
understand the required maneuver.
3
2 If necessary, use the search tool in order to find the patient. Click on Search.
3 Encode the search criteria: last name, ID and or date of birth. Click on Find.
4 Check the patient details to confirm the right patient has been selected.
Encode the patient details: last Name, first name, ID (facultative), gender, date of
2
birth. Click on OK.
3
On the next screen, encode the additional patient details: physician name,
3
predicted set or ethnia. Click on OK.
1 On the main screen of Expair, verify the right patient is selected in the list.
Make sure the patient is not connected to the patient valve. This could lead to a
2
wrong zero measurement.
3
3 Activate the testing mode by following one of these 2 ways:
If the patient has already performed a test that day, a window appears to verify if
4
you want to complete the current test.
6 Complete the patient’s demographic data (at least height and weight).
3
Verify or encode the instrument dead space (volume of the filter in ml) and the
8
instrument resistance (resistance of the filter in cmH2O/L/s).
3
case of any doubt, please contact your filters supplier.
The resistance and the volume values of the filter have no impact on
spirometry calculation, but for other pulmonary function tests such as lung
volumes or diffusion measurements.
In order to obtain the real barometric pressure, the formula below can be
used:
0.0065 × h 5.255
BPreal = BPcorr × (1 − )
288.15
Where:
- BPcorr is the barometric pressure (in mmHg) corrected at sea level, as
indicated on all external weather stations
- h is the altitude (in meters)
If the signal is horizontal, it means the zero of the flow transducer has
been measured correctly. Go to step 3.
If the signal is not horizontal, it means the zero of the flow transducer has
not been correctly measured.
4
2A Click on Stop button.
Verify the patient is not connected to the valve and then click on
2B
Zero in order to measure the zero of the flow transducer.
Ask to the patient to connect his mouth to the antibacterial filter. Verify there is
3
no leak between his mouth and the filter.
The patient breathes normally several times until the ventilatory resting level
4
(FRC) is established.
5 Ask to the patient to perform a vital capacity maneuver. Two ways are possible:
The patient exhales fully from FRC level to RV, then inhales fully from RV
5A
to TLC.
The patient inhales fully from FRC level to TLC, then exhales fully from TLC
5B
to RV.
• End-tidal expiratory level must be perfectly stable for the reliable calculation of the
different pulmonary volumes;
• During deep maneuver, end inspiratory and expiratory phases must reach a plateau
4
on the volume/time curve to ensure a complete vital capacity;
• If previous criteria are not fulfilled, let’s the patient try again with a maximum of 4
repetitions.
4
1 Select a test by clicking on the corresponding test label.
Select to show or hide the cursors (upper and lower limits on the spirogram).
2 You can optimize manually those cursors with the spirogram editor function (see
hereafter).
3 Use the zoom buttons to modify the size of the spirogram.
4 Verify the numerical values and select the best value to report.
Use these radio buttons to take a test into account for the final report. By
5 default, the software automatically chooses the best effort as the effort with the
largest VC.
6 Comment/interpretation editing mode.
NOTE:
The review mode is applied to current test as well as old tests. You can review, edit and print
an existing test by repeating exactly the steps on above.
4
Toggle each of the buttons you would like to adjust (1-4) and place then your cursor on
the best upper or lower limit of volume (TV or VC) you wish to measure:
If the signal is horizontal, it means the zero of the flow transducer has
been measured correctly. Go to step 3.
If the signal is not horizontal, it means the zero of the flow transducer has
not been correctly measured.
5
Verify the patient is not connected to the valve and then click on
2B
Zero in order to measure the zero of the flow transducer.
Ask to the patient to connect his mouth to the antibacterial filter. Verify there is
3
no leak between his mouth and the filter.
The patient breathes normally several times until the ventilatory resting level
4
(FRC) is established.
5 Ask to the patient to inhale fully, then directly after his lungs are filled...
Ask to the patient to exhale as fast as possible during at least 6 minutes
6 (maximum 10 minutes), followed by a deep inhalation. Encourage him in order to
achieve the best effort as possible.
7 Ask to the patient to breath normally.
Note: The vertical red line indicates when the instantaneous expiratory flow is less than
0.025 L/s. This in an indication for the operator that the patient has nearly achieved a
plateau in volume-time curve.
Flying above the trees indicates that the FEV1 and PEF is complete.
Landing the plane corresponds to 6 seconds of expiration.
The birthday cake is a direct measure of FEV1: when the child blows all the
candles in one second, FEV1 measurement is completed.
For adults, a timer for exhaled time and a bar graph of volume effort can
also be displayed.
5
1 The green check means that the test is acceptable.
The red cross indicates that the test doesn’t meet the ATS-ERS criteria and must
2
be rejected.
4 “OP” means that the criteria must be checked and validated by the operator.
5
Select manually or automatically the best values. By default the software
1 automatically selects the best effort as a combination of the best FVC, FEV1, PEF
even from different efforts.
2 Expiratory volume/time curve, with ‘real zero’ and end-expiratory flow criteria.
For editing mode, click right on the number of the test and select Edit.
5
Toggle each of the buttons you would like to adjust (1-4) and place then your cursor on
the best upper or lower limit of volume (VCE or VCI) you wish to measure:
5
1 Toolbox button for setting of default selections.
Mid Expiratory Flow calculation formula. The most common method is (FVC/2)
2
divided by the time interval between F75 and F25. However, an alternative exists.
Display of the vertical red line when expiratory flow is lower than 25 ml/s.
4
Another end-expiratory threshold can be edited too.
If the signal is horizontal, it means the zero of the flow transducer has
been measured correctly. Go to step 3.
If the signal is not horizontal, it means the zero of the flow transducer has
not been correctly measured.
Verify the patient is not connected to the valve and then click on
2B
Zero in order to measure the zero of the flow transducer.
6
2C Verify the volume signal is now perfectly stable.
Ask to the patient to connect his mouth to the antibacterial filter. Verify there is
3
no leak between his mouth and the filter.
The patient breathes with maximal breathing pattern. Highest tidal volume and
4
frequency.
• Acceptability criteria:
o Tidal Volume should be about 50% of VC.
o Respiratory rate (RR) should be close to 90 breaths per minute.
o Ratio MVV/(40 x FEV1) < 0,80 indicates a submaximal effort.
• Repeatability criteria:
o At least two acceptable maneuvers.
o Difference between two acceptable values lower than 20%.
6
Automatic selection for calculation of the MVV. Edit the analysis time interval
1
and then click on the calculator for the MVV calculation in 1 minute.
If the signal is horizontal, it means the zero of the flow transducer has
been measured correctly. Go to step 3.
If the signal is not horizontal, it means the zero of the flow transducer has
not been correctly measured.
Verify the patient is not connected to the valve and then click on
2B
Zero in order to measure the zero of the flow transducer.
7
Ask to the patient to connect his mouth to the antibacterial filter. Verify there is
3
no leak between his mouth and the filter.
7
1 Define the duration of the test.
Parameter Default
Description
name unit
TV L Tidal Volume
VC L Vital Capacity
IRV L Inspiratory Reserve Volume
ERV L Expiratory Reserve Volume
Ti s Inspiratory cycle Time
Ttot s Total cycle Time
Parameter Default
Description Formula
name unit
IC L Inspiratory Capacity TV + IRV
EC L Expiratory Capacity TV + ERV
Ti
Ti/Ttot -- Ratio of the Inspiratory over Total cycle Time
Ttot
60
RF #/min Respiratory rate
Ttot
Parameter Default
Description
name unit
FEV1 L Forced Expiratory Volume after 1 second
FVC L Forced Vital Capacity
PEF L/s Peak Expiratory Flow
MEF25 L/s Flow at 75% of Expired Volume
MEF50 L/s Flow at 50% of Expired Volume
MEF75 L/s Flow at 25% of Expired Volume
FIV1 L Forced Inspiratory Volume after 1 second
PIF L/s Peak Inspiratory Flow
FI25 L/s Flow at 25% of Inspired Volume
FI50 L/s Flow at 50% of Inspired Volume
FI75 L/s Flow at 75% of Inspired Volume
TV L Tidal Volume
IRV L Inspiratory Reserve Volume
8
ERV L Expiratory Reserve Volume
Ti s Inspiratory cycle Time
Texp s Expiration Time
FVC ins L Inspiratory Forced Vital Capacity
FEV0.5 L Forced Expiratory Volume after 0.5 second
FEV3 L Forced Expiratory Volume after 3 seconds
FEV6 L Forced Expiratory Volume after 6 seconds
EV L Extrapolated Volume
T0 s T0 time (time to extrapolated volume)
BTPS Fact -- BTPS Factor
Parameter Default
Description Formula
name unit
FEV1/FVC % FEV1 / FVC ratio (Tiffeneau ratio) FEV1
100 ×
FVC
FEV1/VC % FEV1 / VC ratio FEV1
100 ×
VC
MEF L/s Mean Expiratory Flow 25-75% FVC
2 × Time(MEF75 → MEF25)
MIF L/s Mean Inspiratory Flow FVC ins
2 × Time(FI25 → FI75)
F50 Ex/In % % MEF50
100 ×
FI50
MEF/FVC Hz MEF/FVC ratio MEF
FVC
MEF/VC Hz MEF/VC ratio MEF
VC
IC L Inspiratory Capacity TV + IRV
EC L Expiratory Capacity TV + ERV
FEV1/Ti L/s FEV1/Ti ratio FEV1
Ti
FEV1/FEV6 % FEV1/FEV6 ratio FEV1
FEV6
EV/FVC % EV/FVC ratio EV
FVC
FEV1/VCmax % FEV1/VC ratio FEV1
max (VC, FVC)
F25-F75 L/s MEF25-MEF75 difference MEF75 − MEF25
Parameter Default
Description
name unit
Vmin L/min Ventilation litres per minute
TV L Tidal volume
RF #/min Respiratory Frequency
8
Vol Pef L Volume at peak flow
Tex Pef s Time to reach peak flow
Mef 75% Vt L/s Expiratory flow at 75% of the Tidal volume
Mef 50% Vt L/s Expiratory flow at 50% of the Tidal volume
Mef 25% Vt L/s Expiratory flow at 25% of the Tidal volume
Tex s Time of expiration of tidal volume
ME L/s Mean expiratory flow
Pef L/s Peak tidal flow
Vol Pif L Volume to peak inspiratory flow
Tins Pif s Time to peak inspiratory flow
Tin s Time for inspiration cycle
MI L/s Mean inspiratory flow
Pif L/s Peak inspiratory flow
Ttot s Time of total cycle.
Parameter Default
Description Formula
name unit
RF/TV 1/min/ Ratio of Respiratory Frequency to tidal volume RF
L TV
MVV/Vmin -- Ratio of MVV to ventilation MVV
Vmin
Tin/Tt -- Time of inspiration /Time total ratio Tin
Ttot
Tex/Tt -- Time of expiration /Time total ratio Tex
Ttot
Tin/Tex -- Time inspiration /Time expiration ratio Tin
Tex
ME/MI -- Mean Expiratory Flow/Mean Inspiratory flow ratio ME
MI
F75%/Pef -- Flow at 75% of the Volume to Peak flow ratio Mef 75% Vt
Pef
Pef/TV 1/s Pef/TV ratio Pef
TV
VPef/VPif -- Vol Pef/Vol Pif ratio Vol Pef
8
Vol Pif
TPef/Ttot -- Tex Pef/Ttot Tex Pef
Ttot
Tex/Tin -- Time expiration /Time inspiration ratio Tex
Tin
VPef/TV -- Volume at Pef/Tidal Volume Vol Pef
TV
TV/kg Ml/kg Tidal volume to weight ratio MEF
VC