Alternative applications of ndd spirette

Frequently asked questions about EasyOne Pro
Sales Issues
1. Why do I not need to calibrate the EasyOne Pro?
o ndd TrueFlow to measure flow is proven long term stable. In fact there is
no calibration button on any of our many thousand equipment in use for
over a decade now.
� Over 40’000 EasyOne equipment throughout the world are since
2000 in use and frequently checked for proper functioning . For
more information on references in your area see:
http://www.ndd.ch/AboutUs/references.aspx
� For publications on the subject long term stability refer to:
http://www.ndd.ch/Downloads/scientific_docs.aspx screen for “no
calibration”
� The technology is described in:
http://www.ndd.ch/UserData/Download_00210_00.pdf
o ndd MolMass to measure He dilution for lung volume is applied physics
(molar mass difference in direct proportion to He concentration) and
cannot / must not be calibrated. For more explanation refer to
http://www.ndd.ch/AboutUs/Technology/molmass.aspx
o The CO sensor in fact is automatically calibrated frequently in the
background with the patient diffusion gas itself.
o For all QC assurance procedures you may of course follow the internally
provided procedures with Levy Jennings plots and other QC diagnostics:
� Bio Cal check using standard persons from your crew
� Syringe procedures variable or single flow
� Simulator cal checks
2. Why do other systems need to calibrate daily?
Flow
All other systems which do not apply ndd patented TrueFlow technology use
mechanical sensors; placed within and subjected to the sample breath
stream.
All flow measurement systems based on pressure drop (orifices, Fleisch
pneumotachograph etc.) and all systems based on turbines and heated wires
are subject to:
o A transducer / amplifier converting the measured secondary effect
(pressure drop, turbine speed, heat loss into an electric signal have
naturally
� Linearity issues
� Stability issues
o Any mechanical sensor in contact with the breath suffers contamination
and hence a drift to be considered and cleaned away frequently.

� Some contamination like patient discharge may be filtered out, but
this causes resistance and low flow threshold problems
� Other effects like condensation of existing humidity are being
formed regardless of filters and affect the measurement in a similar
manner as contamination
o Contamination builds up
� And needs to be adjusted for
� Needs to be cleaned away frequently and then re adjusted
Gas composition
All other systems which do not apply ndd patented Molar Mass technology
apply some classical gas component measuring system.
These gas sensors need to be calibrated using reference gases:
o A basic calibration can be achieved uisng 2 reference gases
o For higher quality 3 reference gases are required in order to take into
account the non-linearity of the sensor.
o hence involving complex calibration methods
o and relying on the accuracy of locally supplied gases !!!
Why is ndd calibration free?
ndd applies the ndd patented TrueFlow and Molar Mass measurement which
is uniquely different:
Flow by ndd TrueFlow
As implemented with EasyOne and meanwhile proven by evidence ndd True
flow is “life time stable”.
L td
− tu
F = ⋅
2cosϕ
t ⋅t
d
u
A simple time measurement (of course calibration free, quarz based)
measures the transit-times of ultrasonic pulses traveling up- and downstream
the gas flow:
o up-stream pulses are faster (i.e. smaller transit-time)
o down-stream pulses are slower (i.e. larger transit-times)
Using the above formula flow speed can be computed independently of any
variables (temperature, humidity, ambient pressure, gas density etc.).
Using flow speed the volume can be computed easily.
Since there is no mechanical sensor in the gas stream, there is no
maintenance, no drift, no effect of contamination.
Gas composition by ndd Molar Mass
The Molar Mass measurement determines the mean molar mass of the gas
composition (i.e. the percentage weighted sum of all molar mass values of
the gas components).
4 ⎛ tu
⋅ td
M = κ ⋅ R ⋅T
⋅ 2 ⎜
L ⎝ tu
+ t
d
⎞
⎟
⎠
2
Molar Mass can therefore be used to measure changes in gas compositions.
The molar mass measurement must not be calibrated and it is completely
linear over its measurement range. We therefore do not need to calibrate with

the exception of CO, and this is done automatically and in a new way as
explained below.
EasyOne Pro measures:
Flow and main-stream Molar Mass at the very same spot (same sensors) near
patient.
Helium by MolMass and CO by NDIR in a side stream arrangement.
To have a precise time-alignment of all measurements (Flow, He, CO) the
delay of each signal is automatically determined using a patented technology.
The automatic delay correction is also calibration free and is performed for
each test.
He; Helium by Molar Mass
We perform a 2 point calibration:
1. Air being zero He
2. Test gas being the working range maximum (concentration of the bottle
as indicated by supplier)
The absolute concentration is for ndd technology relatively unimportant since
the relative Molar Mass measurement contains all the information needed to
do accurate DLCO
The absolute concentration is IMPORTANT for all simulator based
measurements since the absolute concentrations of the reference gas bottles
are compared to the absolute concentration of the DLCO test gas.
The Molar Mass calibration is automatic an never requires any external gases.
CO, Carbon Monoxide
We perform an fully automatic 3 point calibration
3. Air being the zero CO
4. test gas being the working range max
5. mid range: The exact gas mixture is determined by Molar mass and then
used to calibrate the CO sensor at the mid point. Using this technology
(patent pending) the non-linearity of the CO sensor can automatically be
determined for each test.
All calibration steps are fully automatic and with no need for any external gas.
Ambient variables input
No variables must be entered since all are either measured or irrelevant
For the side-stream systems the humidity difference between inspiratory and
expiratory measurements is equalized by conditioning of the sample to
environmental level through Nafion® (parmapure) technology.
3. How long does it take to set up EasyOne Pro “from scratch” and then
every time I want to use it?
o The first time the intuitive process (the proverbial 1,2,3) may take up to
10 minutes, following the instructions in the manual
� Connect the gas , the patient tube and adjust the regulator pressure
� Connect the mains power (100-240VAC) and switch on
� Run through the set-up routine

o Any subsequent times, including in different locations, it just takes 2-3
minutes to be ready for measurements, no warm up, no checks, no
maintenance and of course no calibration.
4. How long does it take to measure one patient (LFT: spirometry and
DLCO)?
o It typically takes under 19 minutes for one patient: explanations,
spirometry (BD) and DLCO in practical application with EasyOne Pro; on
remote locations and similar in home site (reference by Respiratory Testing Services,
Fremantle, WA, Australia; May 2009; timed on 2 locations with over 30 patients)
o Important EasyOne Pro features for time saving:
� Hand held sensor assembly, fast, easy and lip tight docking to
patient, no positioning manipulation of support arms needed
� Touch screen display, all operations and operator / patient
interactions on the same screen
� Customer designed report format and print out from main
equipment (no PC required)
� On board software for data processing etc. (free export)
� State of the art design: latest technology, latest hardware
generations, windows based dedicated built-in PC
5. What are the running costs for EasyOne Pro?
o You will need a new spirette and barriette for hygienic reasons for each patient,
for prices refer to the local source, usually well under USD 5. These are the ONLY
consumable required.
o The gas (0.3%CO; 10%He; 18-25% O2; N2) consumption is ca. 5 liters per
inhalation, so typically 10-15 liters per patient
o The power consumption is so low that you may easily use an uninterrupted power
supply (UPS) for “total independence”: bed side, occupational sites etc.
6. Why should I prefer ndd EasyOne Pro over other brands / models?
o ndd is the company that has set the new standard in spirometry:
� true flow (ultrasonic transit time measurement)
� spirette the new hygienic consumable that allows calibration free
(no sensor) use of TrueFlow based instruments.
� References are published from Platino to BOLD, from USA to
Australia
o EasyOne Pro is the first and only instrument based on the new ATS/ERS
standard for DLCO measurement
o And developed by using the new ATS ERS approved simulator
o EasyOne Pro features the same ndd benefits as does the word wide
successful and best sold spirometer EasyOne:
� No calibration
� Ready to use at the touch of a button
� Test QC monitored (and logged) for ATS / ERS compliance
� User prompts to achieve best trials
� Maintenance free, no service parts required,
� but with a new and convincing trouble shooting concept; assuring
help when and wherever needed and backing up the ndd promises.
� It is the brand / instrument preferred by opinion leaders.

• By design of its patented technology TrueFlow and
MolMass currently only available at ndd and a few selected
OEM Partners.
o You will always need only one gas, the DLCO diffusion gas (CO/He/Air),
nothing else.
7. Do you follow the ERS ATS 2005 guidelines
o Yes, EasyOnePro is the first (and so far only) equipment that has been
developed AFTER these guidelines were published. Therefore we match
them better than anyone else.
See:
http://www.ndd.ch/Downloads/scientific_docs.aspx
o Also we are conform with the Hans Rudolf Simulator developed by Crapo /
Jensen. Published results: best out of 6 major brands.
Technical Issues:
8. What size of gas bottle should I order?
o The size is a consideration between the following key aspects depending
on your own preferences:
• # of patients you want to measure per bottle
• Usually the gas has a certified stability for 2-3 years
• Ease of portability required (down to for example 5l for
bedside)
o Attention the filling pressure may be higher with big
bottles (250atm with 20 and higher l) and lower with
small bottles (150 atm. at 5l)
9. Uninterrupted Power Supply (UPS) for EasyOne Pro
o If the power supply has interruption or large Voltage Fluctuations a UPS
units is necessary.
o For specific calculation see:
http://www.apc.com/tools/ups_selector/index.cfm
Note the following specifications:
� Power consumption EasyOne Pro: 80VA (Volt-Ampere, similar to
Watt)
� Use only a slow fuse of 3 Ampere.
� The UPS need to supply 160Wh (Energy for a 2 hour power
interruption)
� For USP usually the Rating is indicated in Watt or VA this value
need to be at least 80 VA
� Depending of the lengths of the power interruption the backup time
value is important. UPS provider indicate this value usually in
Minutes (Example: 700VA � Back uptime 30 min with 50% load)

That means for EasyOne Pro (80VA) the backup time is around 2
hours.
o UPS Units can be bought in most electronic shops.
10. Why are there He and CO curves during tidal breathing?
o The MolarMass Signal is influenced by the MM of the Inspiration gas (MM=28.95
g mol -1 ) and the MM of the expiration (MM=29.78 g mol -1 ). (Green Line) During
tidal breathing. T his has nothing to do with Helium. ( No He gas apply during tidal
breathing)
o The purple line (CO) during tidal breathing is measuring the blank value which
will be deducted in the exhalation.
The scientists believe that during this tidal breathing phase both the He (Green Line)
and the CO (Brown Line) should be flat. Yes but we use it to measure and calibrate the
molar mass signal
11. Does EasyOne Pro give the “same results” as the instrument(s) I
am using currently, do the results match?
o The issue of quality of DLCO results is a very complex one. A published
ERS article deals with the aspects addressing this subject and is
recommended reading for anyone concerned with quality issues:
http://www.ndd.ch/UserData/Download_01471_00.pdf
o EasyOne Pro is the first and so far only instrument that has been
developed based on the ATS/ERS accepted standards of the Hans
Rudolph (Crapo/Jensen) simulator (designed around 2005)
o According to statements by the lead author of the above mentioned
article EasyOne Pro is as close to the standards as he has seen it possible.
And there is no calibration ! No “wrong” manipulation.
o Another poster deals with the current situation of leading brands:
http://www.ndd.ch/UserData/Download_00210_00.pdf
o Your ndd dealer has a Hans Rudolph simulator available to make your
evaluation easier and base it on the only internationally accepted standard
available today.
12. How does single breath DLCO compare to multi breath?
o Single breath DLCO is the only DLCO method standardized by “ATS/ERS:
Task Force; Standardization of Lung Function Testing” and as such the
guide line: http://www.ndd.ch/UserData/Download_01384_00.pdf All
considerations are dealt with in this publication.
13. How does single breath TLC compare to other methods?
o The relationship and circumstance are described in the publication linked
here http://www.ndd.ch/UserData/Download_01468_01.pdf
o If the TLC is "adjusted" with the Punjab equation, then RV would need to
be recalculated. Since TLC = RV + VC, and using FVC as the VC then RV =
TLC - FVC. This is simple, and the increase in RV will be equal to the
increase in TLC due to the Punjab equation. So if the "Pre Punjab" TLC is

say 4.5 and FVC is 3.5 it follows that the RV is 1.0 (TLC - FVC) and it follows
that RV/TLC ratio is 1.0/4.5 or 0.22. If the Punjab equation increases the
TLC from 4.5 to say 5.0, FVC stays the same so the new RV = 5.0 - 3.5 =
1.5, and the new RV/TLC ratio is 1.5/5.0 or 3.0. But keep in mind that the
new RV/TLC ratio is "NOT" the old RV (1.0) divided by the "NEW" TLC (5.0),
which would equal 0.20.
14. What is UPG, the 3rd available mode in EasyOne Pro?
o Ultrasound Pneumology: is a new ndd developed tidal breathing
measurement combining the CO2 concentration measurement with flow
(TrueFlow and MolMass at the same time and point of measurement).
o The resulting CO2 / flow - volume capnography curve shows changes of
slopes and in the different phases.
o The changes in appearance (shape) are characteristic for certain lung
diseases and their severities
o Several publications regarding Vd (Fowler), COPD classification:
http://www.ndd.ch/UserData/Download_00158_00.pdf etc. have been
published.
o The optionally available UPG mode allows measurements for R&D
purposes in a standardized hardware setting with a research SW..
15. Displayed Device Messages
Message 1 – Check Spirette insertion
Message is shown in the following cases:
- Spirette not correctly inserted
- Use of old or defective Spirette
- First measurement on different altitude as last
measurement (e.g. first measurement in
Mexico City after measurement in Switzerland)
Message 2 – Save New Values
How to avoid message:
- Correctly insert Spirette (completely and with
correct position, see position marker)
See also chapter “inserting the spirette” in the
operator’s manual.
- Use new ndd Spirette
- If this message is shown repeatedly, another
message with a question to save values is
shown, press “Yes” and repeat measurement.
Message is shown in the case, where the
“Check Spirette Insertion” message was
shown several times. This means that the
signal amplitude has changed. If Spirette
is correct inserted press “Yes” to save
the new values. This might be necessary
on large altitude changes between
measurements.

Message 3 - Device initialization failed! Retry or call your local service agent
This message is shown if “No” was
pressed in above showed “Save New
Values” dialog. Press “Yes” to save the
new signal amplitude values.
Other Reported Messages
volumen de muestreo en posición maxima: Appeared with the DLCO calibration with syringe.
Sampling volume at maximum position.
This message is shown if:
- The expired volume was too small (expired volume should be > 1liter)
- If it was not exhaled immediately after the DLCO valve has open after the breath hold.
- If no stable gas concentration plateau during exhalation after breath hold was detected.
E.g. too low expiration flow.
- Do you have a screenshot of that test?
Fallo en CO calib: in the biological control.
Test Failure: CO-Calib? More details required and exact error message.
Does this happen several times? Was the gas connected? Is everything correctly
mounted and the system is tight?
Is it only the case in the biological control? Could you send the database or a
picture of the maneuver?
16. Absence or faulty CO/MM Curve (Human Test)
Different Error Messages occur when the Activate Button is pressed to late.
� The DLCO Valve unit does not close

For correct timing proceed in the following way:
Advice Patient for tidal breathing:
Advice Patient to exhale
Press Activate while patient exhale

Attention!
Press Activate at the early Start of last expiration well before
gas inhalation. The Instrument automatically detects end of
exhale and opens the gas demand valve (audible sound)
17. Which breath hold time definition do you apply?
We apply the Jones Meade breath hold definition as specified in the ERS ATS, you
can select between 8 and 11 seconds hold time.
18. Why are we not getting a predicted for the VA and the KCO?
the predicted reference used is Miller – and also why is it not reporting the breathhold
time?
The VA parameter has only a predicted in the Knudson reference. Therefore also
the KCO (which is DLCO / VA) will have a predicted in the Knudson reference.
19. About breath hold time (BHT)
The breath hold time (BHT) is only shown for each trial. There is no definition for a
summary value of the BHT. Therefore in the summary report the BHT is not shown.
In the DLCO report you have the table with values for each trial. There you should
see all BHTs. You can add this table also to the summary report if you wish.

20. Mark DLCO attempts as unacceptable.
Double click first at position (1.), then click on the scroll bar (2.) and then press
the button (3.).
21. Show date of test in patient list
In order to increase the performance the last test date is not shown by default.
The current logo seems not very intuitive ... The screenshot below shows you how
to show the dates:
22. How does the EasyOne Pro know that a VI target of 85% has been
achieved?
The Inspiratory Target Volume in the EasyOne Pro is set at 85% of the patient’s VC
max value which we know from the patient’s previous tests (DLCO, FVL, or SVC) or
in the case of a new patient where spirometry is not performed prior to the DLCO
Test then we use the predicted VC, FVC value for that patient.
23. How does the operator know when a patient has performed a
Valsalva Manoeuvre or Muller Manoeuvre as there does not seem
to be any mouth pressure measurement as there is with other
DLCO systems?
The EasyOne Pro does make a mouth pressure measurement during the DLCO Test
which you can select at the end of the DLCO Test and you will see the pressure
gradient and the pressure value displayed in Mbar and also the Flow plot and
display in LPS.

24. Sample and Washout Volumes
We “let it all out”, analyze the curve and pick the respective segments, including
discard volume. That is (in fact quite often) more than 1 liter and goes against the
traditional understanding. But it is correct.
See the following extract from the ERS ATS guide lines 2005
25. Restriction for EasyOne ProSoftwareupdate
Please do not use MAC for unzipping Software update package.
26. Any new question?
For any other question or to get references please do not hesitate to contact Juerg
Anderauer: Anderauer@ndd.ch or mobile +41 79 238 6804.
Sepember 2010
Juerg Anderauer