|
 What is DLCO?

O The diffusing capacity of

the lung for carbon
monoxide (DLCO), also
referred to as the
transfer factor of the
lung for carbon
monoxide (TLCO)
It is used to evaluate the
transfer of gas from the
distal air spaces into the
pulmonary capillaries

 What is DLCO
O It is measured when a
known but very low
concentrations of carbon
monoxide (CO) is inspired.
O The rate of CO
disappearance is calculated
from the ratio of the CO
concentrations of the
inspired and expired gas
and then expressed as a
function of the driving
pressure (mL
CO/min/mmHg).
O This can be expressed in the
equation below:


O 

'
D '

Where: CO is the uptake of
CO in [mL] of CO at STPD
conditions per minute
PACO is the average partial
pressure of CO in alveoli
PCO is the average partial
pressure of CO in the
pulmonary capillary plasma

 DLCO History

O The 10-second single-breath holding technique is the

most widely used. It was introduced by August
Krogh around 1915, and later refined by Forster and
coworkers, Ogilvie and coworkers, and McGrath and
Thomson.
O Two 10-second single breath holding techniques
have emerged: (1) breath-holding with an alveolar
sample bag, and (2) breath-holding with a rapid
response gas analyzer and no alveolar sample bag.


 Why is DLCO Important?
2005 ATS-ERS Interpretation
Taskforce single Breath͙

Î
 Are there Predicted values?

There are predicted values available, but͙

͙a single ͚͚summary͛͛ prediction equation is in
the works by an ERS/ATS taskforce
However, due to high inter-laboratory variability.
Commonly used equations are
O 1993 ERS
O CRAPO and MORRIS
COTES
PAOLETTI
ROCA

 Why the DLCO Simulator?
O Designed by Hans
Rudolph and Drs. Crapo
& Jensen
O EasyOne Pro is the first
device developed using
this world-wide
accepted QA
O It is like the 24
Spirometry waveforms
for DLCO


 The EasyOne Pro is͙

Significantly different from existing PFT

(Pulmonary Function Test) equipment:
ͻ No Calibration
ͻ Portability
ͻ Single Gas requirement
ͻ Superior accuracy
ͻ Hygienic, preclude cross contamination
ͻ Lowest consumable and running costs
ͻ No down time
Ú
 The EasyOne Pro is͙

Significantly different from existing PFT

equipment
ͻ Small footprint (> 50% smaller than others)
ͻ Completely self contained system:
O Internal PC
O Internal color touch screen monitor
O Internal touch screen keyboard
O Simple, hygienic patient interface
O Flexible

Existing Products

|
 Who is your competitor?

O Carefusion O N͛Spire
Jaeger Master Screen Eagle
Diffusion ZAN
SensorMedics Vmax 22d O Ganshorn
O COSMED O Medical Graphics
Quark PFT Model 3 Ultima PF
O Medisoft O Morgan Scientific
SpiroAIR
O Collins

||
Competition Patient Interfaces

|

 Significant Improvements
O All in one design
O Small Footprint
O Portability
O Handheld light weight sensor assembly
O No support arm restriction
O Near patient interaction / coaching
 The EasyOne Pro is͙

iesigned specifically to meet the needs of

Pulmonary and specialized physicians
performing pulmonary function testing in:
O Private offices
O Alternate testing facilities
O Point-of-care (bedside, outpatient)
O Laboratories
O Satellite labs
O Branch labs |
 X


  

ͻ The EasyOne Pro utilizes state-of-art technology,

providing the operator with reliable,
maintenance-free day-to-day performance.
ͻ The worldwide accepted ndd ultrasound
technology in combination with:
stable, ultra-fast gas analysis sensor technology, provides
the user with the first calibration-free pulmonary function
testing system

|Î
 The EasyOne Pro is͙
±ffordable to the end ±s future options are identified
user and profitable for and developed, new
ndd partners: configurations will allow
ë The EasyOne Pro is penetration into new markets
designed to be easily such as:
packaged to meet the ë University Laboratories
unique needs and ë EMR
requirements of the
worldwide market. ë Cardiology
ë This is achieved by the ë Membrane Diffusion
list of available options ë Pharmaceutical Clinical Trials
which can be bundled or ë 21 CFR Part 11
quoted individually. ë Epidemiological Studies
ë Internet Database Review
ë Occupational Testing
ë Unidentified markets |
The Future

|
The Future

|Ú
A
 
¢ntended ±udience

This manual is
intended for ndd
authorized service
personnel that
uses, maintains,
or troubleshoots
this equipment.
EasyOne Pro Main Unit
 Technical Details of Components
±  


  
 
    
 

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 Sensor
and
¢nterface
 Flowsensor
Flow and molar mass
measurement of
inspired and expired
gas
 ¢nternal sensor
side stream
measurement of
expired gas.
 — Sensor
A sensor based on
NDIR technology for
the CO measurement
of the gas sample.
Linearity calibrated
 ndd Spiroson x2 Board
Supplies CO analyzer
with patient sample
gas.
Block iiagrams
 Ambedded P—
and ±ccessories
 Ambedded P—
O Industrial PC
O Harddisk Drive
O TFT Screen with Touch
Panel
O Medical grade multi
voltage Power supply
O Flash Memory Drive
2




 
 




    

 




   


 
TL— / iL— Gas supply
Primary Gas supply (locally available)
Gas specification of gases that may be used
with EasyOne Pro (target value +/- 10%,
precision +/- 2% accuracy, medical grade gas
only)
o Helium (He): 10% (ð2%)
o (Jaeger-gas 9% allowed)
o Carbon Monoxide (CO): 0.3% (= 3000ppm)
o Oxygen (O2): 20.9%(18 ʹ 25%)
o Nitrogen (N2) balance
 Pressure Reduction Valve
O Pressure reduction valve
Pressure range: 0͙6 bar
Flowrate: 6͙10L/sec
O Quick Connector for Gas
Regulator. Specification:
10mm (outer diameter) tube
(7x10mm PU, polyurethane)
O Order number:
È -5

SP
 Pneumatic Bloc
Control of gas supply and
gas sampling including a
safety over-pressure relief
valves on supply side(8
bar) and patient side (5
mbar)
Contains valves for
calibration cycles
 iemand Valve
Provide test gas with low
pressure, high flow and low
resistance on patients
demand.
Technical details:
ͻ Demand Pressure ndd:1-2mbar
Competitor: ca. 10 mbar
ͻ No vibration at low flow͛s
(Spez. ndd attenuation system)
ͻ Flow: Bis 6l/sec
ͻ Immediate flow-stop in case of
loss of patient demand
 ndd iL— Valve
Deliver test gas to
patient, transport gas
sample from patient to
internal gas sensors.
ͻ Maintenance free
driving system
ͻ Easy cleanable surface
ͻ Quick acting
ͻ Leak tight
ͻ Integrated Sample line
 åotor Block
Open and close the DLCO Valve
ͻ Fast acting
ͻ Maintenance free
ͻ Integrated automatic power
connection
ͻ Exact positioning of the DLCO
Valve
ͻ Snap-On Function for easy
handle
 Filter Pack
Easily exchangeable set for gas
humidity adjustment and filter
for dust protection. This
assures a conditioned uniform
sample.
ͻ What͛s Nafion® : Humidity
(H2O) permeable
membrane (tube) Adjust
sample gas to ambient
Humidity and Temperature.
ͻ Automatic positioning
ͻ Changeable with one screw
 Gas supply tube
Supply patient on demand with
DLCO gas. The internal nafion
tube supplies the CO Analysator
with the expired gas from the
patient. Low gas flow resistance

ͻ FDA approved
ͻ Integrated Sample line
ͻ Dust filer integrated in Sample
line
ͻ Easy to connect (reliable
Tightness )
ͻ Smooth material (max.
Flexibility)
 Pressure tube
Supplies EasyOne Pro
with the DLCO Gas.
ͻ FDA approved
ͻ Special material to
prevent He diffusion
ͻ Connectable without
any tools
ͻ No additional
connector necessary
 One-way valve
O Prevents backflow of
expired gas /
contamination
O Easy changeable
O Integrated Sample line
O Properly positioned
(bayonet lock)
O Opens with ca. 1-2 mbar
(normally closed 0 mbar)
O Allows secure placement of
BarrietteTM
 Overflow Valve

O Overflow valve during the

flushing process.
O Pressure relieve valve <3
mBar.
O Easy changeable
O Self cleaned
O In case of overflow, Patient
is protect from airflow
 BarrietteTM

O Virtual Filter for exhaled

flow.
O collects exhaled
contaminated particles by
absorption
O Hydrophobe net repels
exhaled moisture
O Collects sample gas
O seals spirette effectively
O prevents cross
contamination
O Single packed
O Easy to handle
O Low costs
UPG Side stream sample adapter
used for UPG side stream
procedures
Instead of barriette
 Service Schedule
Consumable: Replacement:
°
   
 °
   
O Spirette O Filter pack
O Bariette O Gas supply tube
O One-way valve
Changeable Spare parts
(no case opening necessary, no adjustment )

O Near patient sensor

O Gas Supply Tube
O One way valve
O Overflow valve
O DLCO Valve
O Motor Block
O Temperature/Humidity Sensor
O Filter pack
O Gas supply tube
O High pressure hose
O Power supply cable
 Service Procedures
1st Level Service 2nd Level Service
° 
O Calibration Checks °  
O Software update O 1st Level Service
O Replacement parts:
Õear patient sensor O Case- Opening und
Gas Supply Tube Closing
ne way valve
verflow valve O Visible Check
iL— Valve ± Pneumatics
åotor Block ± Wiring
Temperature/Humidity
Sensor O Electrical Safety Check
Filter pack
Gas supply tube ± Xesistance (until And of 2  )
High pressure hose ± Alectrics
Power supply cable
O Function Test
± Spirometry
± iL—
Service Procedures
3rd Level Service
°   

O Troubleshooting with ndd-
Support
O Follow the supporters
Instruction
 —alibration —heck
O EasyOne Pro can not be calibrated!
O HOWEVER
O In case of any doubts calibration checks are
available:
DLCO Bio-Cal-check
DLCO Simulator Cal-check
 iL— Bio-—alcheck
O A Bio-Cal-Check tests the performance of the
equipment and operational reliability without
using a calibration tool.
O A Biological Standard subject (BioCal Subject,
usually 1 or more operators) performs a series
of tests which are observed and statistically
controlled.
O The data will be collected on individual
healthy, non smoking BioCal Subjects.
 Perform iL— Bio-—alcheck
O Start application
O Open menu Ë   
O Open menu ——    

O Open menu o   —    

— (Main Screen BioCal-Check is
opened)
O    Select device according to serial number (check label
on sensor)
O o     Select subject which performs the BioCal-
Check test. If the subject is not in the list, press ±o — 
and select or add new subject. Afterwards return to BioCal-Check
menu.
X       
 o o  !
O Press ±
O Perform Test (Test selection: DLCO, (or TLCO,) VA, others as applicable
X    "
  #M—
 ± 
X    $

  o 
  
O Press 2

O The result is shown in the ±
   section and the  section.
 iL— Simulator —alcheck
O The full DLCO Simulator Calcheck Procedure is
availabel on:
http://www.ndd.ch/UserData/Download_01797_01.pdf
 F±

http://www
ndd
ch/Useriata/iownload_ È_ 2
pdf

Why do ¢ not need to calibrate the Aasy ne Pro?

ͻ ndd TrueFlow to measure flow is proven long term stable.
ͻ Over   Aasy ne equipment throughout the world are since
2000 in use and frequently checked for proper functioning .
ͻ ndd MolMass to measure He diffusion for lung volume is applied
physics and cannot / must not be calibrated.
ͻ The CO sensor in fact is automatically calibrated frequently in the
background with the patient diffusion gas itself.
ͻ For all QC assurance procedures you may of course follow the
internally provided procedures with Levy Jennings plots and other
QC diagnostics:
O Bio Cal check using standard persons from your crew
O Syringe procedures variable or single flow
O Simulator cal checks
 F±

What are the running costs for Aasy ne Pro?
ͻ You need a new spirette and barriette for each patient,
prices refer to the local source (around 5$)
ͻ These are the ÕLY consumable required

ͻ The gas (
È—   He -25 2 Õ2) consumption
is ca
5 liters per inhalation, so typically  -5 liters per
patient
ͻ The power consumption is so low that you may easily
use an uninterrupted power supply (UPS) for ͞total
independence͟: bed side, occupational sites etc

 F±

ioes ndd follow the AXS ±TS 2 5 guidelines?
ͻ Yes, Aasy nePro is the first (and so far only) equipment
that has been developed strictly in accordance with
these guidelines

ͻ ±lso we are conform with the Hans Xudolf Simulator
developed by —rapo / Jensen
Published results: best
out of 6 major brands

 F±

What size of Patient test gas bottle should ¢ order?
The size is a consideration between the following key
aspects depending on your own preferences:
O # of patients you want to measure per bottle
O Usually the gas has a certified stability for 2-È
years
O Aase of portability required (down to for example
5l for bedside)
 F±

Supported Printer (Currently available on request)
save Xeport as
pdf (Axport)
P—L Printer (network)
Pre installed printer :
O HP 6,
O ieskjet 6 HP,
O fficejet H
all others need further printer driver
 F±

—onfiguration for network printing
O åain åenu
O Configuration
O Printer: 
 2
 
  HP Universal Printing
P—L5 (Õetwork printer) confirm with ok
O Select Test you want to print

O 1. Press Printer
O 3. Select search for Network printer
O 2. Change to Printer Window
O 4. Select the printer you want to print
 F±

±bsence or faulty — /åå
—urve (Human Test)
O iifferent Arror åessages occur
when the ±ctivate Button has
been pressed to late

O R The iL— Valve unit does not
close
O For correct timing proceed in the
following way:
O ±dvice Patient for tidal
breathing:
O ±dvice Patient to exhale
O For correct timing proceed in
the following way:
O ±dvice Patient for tidal
breathing:
O ±dvice Patient to exhale
O Press ±ctivate at the early
Start of last expiration well
before gas inhalation
The
¢nstrument automatically
detects end of exhale and
opens the gas demand valve
(audible sound)
O ¢n Future SW Version:
O ±utomatic closeing (when
fully exhaled)
O åanual closeing (triggered by
click)