EasyOne Pro™
EasyOne Pro™ LAB
Operator's Manual
Version V03C
Note
The information in this manual only applies to software
version V01.04. It does not apply to earlier software
versions.
Due to continuing product innovation, specifications in this
manual are subject to change without notice.
© ndd Medizintechnik AG, Zürich, Switzerland. All rights
reserved.
No part of this manual may be reproduced without written
permission from ndd.
ndd™, the ndd logo™, EasyOne Pro™, barriette™ and
spirette™ are trademarks owned by ndd Medizintechnik AG.
This manual describes the product EasyOne Pro™ and its
variant EasyOne Pro™ LAB. The safety information and all
operating instructions apply to both devices. Safety
information and operating instructions that apply only to
EasyOne Pro™ LAB are accompanied by the symbol shown
at left and by the word LAB.
ndd
Medizintechnik AG
Technoparkstrasse 1
CH-8005 Zürich, Switzerland
Tel: +41(44) 445 2530
Fax: +41(44) 445 2531
www.ndd.ch
2 EasyOne Pro™ / EasyOne Pro™ LAB
USA
ndd Medical Technologies
2 Dundee Park
Andover, MA 01810
Tel: 1 978 470 0923
Fax: 1 978 470 0924
www.nddmed.com
Contents
1 Introduction 5
1.1 CE Marking Information 5
1.2 Revision History 6
1.3 Manual Purpose 6
1.4 Intended Audience 6
1.5 Styles 6
1.6 Safety Information 6
1.7 Intended Use 14
1.8 Contraindications to Performing DLCO Tests 14
1.9 Additional Functions of EasyOne Pro™ LAB 14
1.10 Components and Functional Description
of EasyOne Pro™ 15
1.11 EasyOne Pro™ Flow Sensor Design and Operation 16
1.12 Test Gas Requirements 17
2 Start-up and Initial Preparation 19
2.1 Unpacking, Environmental Conditions 19
2.2 Equipment Description 20
2.3 Preparing the Device 22
2.4 Gas Supply 25
2.5 Connecting the Keyboard and the Mouse 30
2.6 Connecting the Printer 30
2.7 Power 32
2.8 Inserting the One-Way Valve, DLCO barriette™/
FRC barriette™ and spirette™ 33
2.9 Switching the Device On, Functional Test 37
3 Performing a Test 40
3.1 Selecting/Adding a Patient 40
3.2 Selecting a Test 44
3.3 Forced Vital Capacity (FVC/FVL) 45
3.4 Vital Capacity (SVC) 55
3.5 Maximum Voluntary Ventilation (MVV) 57
3.6 Quick Test 59
3.7 CO Diffusing Capacity (DLCO) 59
3.8 FRC Test (EasyOne Pro™ LAB only) 64
3.9 Ending the Test 66
3.10 Retrieving/Printing Stored Tests 66
3.11 Trend View 69
4 Editing Patient Data 71
5 Quality Messages and Quality Grades 72
5.1 FVC/FVL Quality Messages and Quality Grades 72
5.2 SVC Quality Messages and Quality Grades 75
5.3 DLCO Quality Messages and Quality Grades 76
EasyOne Pro™ / EasyOne Pro™ LAB 3
Contents
5.4 FRC Quality Messages 80
5.5 System Interpretation 82
5.6 Retrospective Test Assessment, Entering Comments 82
5.7 Definition of Important Parameters 85
6 Switching the Device Off 88
7 Hygiene, Cleaning, Maintenance, Disposal 89
8System Settings 99
9 Troubleshooting Tips 116
10 Specifications 117
11 Order Information 119
12 Appendix 120
12.1 Interpretation 120
12.2 Predicted Values 123
12.3 GDT Interface 124
12.4 Introduction to Adjustment of DLCO Measurements 130
12.5 How to interpret TLC from a single breath maneuver 132
12.6 Report Designer 134
12.7 Electromagnetic Compatibility (EMC) 138
12.8 Microsoft Software License Terms
for Windows® XP Embedded Runtime 143
12.9 Quick Reference Guide to the Screen Displays 149
12.10 EasyOne Pro LAB Washout Moment Analysis 164
12.11 Literature 165
4 EasyOne Pro™ / EasyOne Pro™ LAB
1Introduction
1.1 CE Marking Information
The product EasyOne Pro™ bears the CE marking CE-120 (notified body
SGS) indicating its compliance with the provisions of the Council
Directive 93/42/EEC about medical devices and fulfills the essential
requirements of Annex I of this directive.
The flow sensor has been assigned to class IIa as specified in Annex IX of
the Directive 93/42/EEC.
The device fulfills the requirements of standard EN 60601-1 "Medical
electrical equipment, Part 1: General requirements for basic safety and
essential performance" as well as the electromagnetic immunity
requirements of standard EN 60601-1-2 "Electromagnetic compatibility
– Medical electrical equipment".
The radio-interference emitted by EasyOne Pro™ is within the limits
specified in EN 55011, class B.
The CE marking covers only the accessories listed in the Order
Information chapter.
Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason make sure that all external
devices operated in the vicinity of the equipment comply with the
relevant EMC requirements. X-ray equipment, MRI devices, radio
systems, and cellular telephones are possible sources of interference as
they may emit higher levels of electromagnetic radiation. Keep the
equipment away from these devices and verify its performance before
use.
The device is suitable for continuous operation.
The product fulfills the requiremens of the following standards:
EN ISO 14971
IEC60601-1: 2005
EN 60601-1: 2006
EN 60601-1-2: 2007
EN 60601-1-6: 2007
The country of manufacture is indicated on the device label.
Introduction
EasyOne Pro™ / EasyOne Pro™ LAB 5
1.2 Revision History
Edition Date Comment
Version V01.01 2008-07-22 Initial Release
Version V01.02 2009-11-23 Revised Edition
Version V02 2010-04-06 Revised Edition
Version V03 2011-11-29 Revised Edition
Version V03A 2012-01-27 Revised Edition
Version V03B 2012-05-23 Revised Edition
Version V03C 2012-08-23 Revised Edition
1.3 Manual Purpose
This manual contains the instructions necessary to employ the product
safely and in accordance with its function and intended use.
1.4 Intended Audience
This manual is geared for clinical professionals. Clinical professionals are
expected to have working knowledge of medical procedures, practices, and
terminology as required for completing these examinations.
Introduction
1.5 Styles
Keys (softkeys and hardware elements) are represented in bold print, e.g.
New Patient, Select Patient.
Terms appearing on the display and product names are italicized, e.g. Last
Name, First Name, EasyOne Pro™.
1.6 Safety Information
General Information
This manual is an integral part of the device. It should be available to the
equipment operator at all times. Close observance of the information
given in the manual is a prerequisite for proper device performance and
correct operation and ensures patient and operator safety. Please note
that information pertinent to several chapters is given only once.
Therefore, read the manual once in its entirety.
6 EasyOne Pro™ / EasyOne Pro™ LAB
Introduction
To ensure patient safety, the specified measuring accuracy, and
interference-free operation, we recommend using only original
accessories available through ndd. The user is responsible if using nonndd accessories.
ndd is responsible for the effects on safety, reliability, and performance
of the device, only if
assembly operations, extensions, readjustments, modifications, or
repairs are carried out by ndd or by ndd-authorized personnel
the device is used in accordance with the instructions given in this
manual.
The warranty does not cover damage resulting from the use of unsuitable
accessories and consumables from other manufacturers.
Always consult with ndd, if you intend to connect equipment not
mentioned in this manual.
Components and accessories must comply with the applicable IEC
60601 safety standards and/or the configured system must comply with
the collateral standard IEC 60601-1-1 "Requirements for the safety of
medical electrical systems".
The power cord must be an approved type acceptable to the authorities
in the country where the equipment is used.
All publications are in conformity with the device specifications and
standards on safety of electromedical equipment valid at the time of
printing. All rights are reserved for devices, circuits, techniques, software
programs, and names appearing in this manual.
The illustrations in this manual are only examples. They are not binding
in any way.
No part of this manual may be reproduced without written permission
from ndd.
© 2012 ndd Medizintechnik AG, Technoparkstr. 1, CH-8005 Zürich,
Switzerland
EasyOne Pro™ / EasyOne Pro™ LAB 7
Definitions
In this manual the safety information is classified as follows:
Safety Notices
Introduction
Danger
indicates an imminent hazard. If not avoided, the hazard will
result in death or serious injury.
Warning
indicates a hazard. If not avoided, the hazard can result in
death or serious injury.
Caution
indicates a potential hazard. If not avoided, the hazard may
result in minor injury and/or product/property damage.
Danger
Explosion Hazard—EasyOne Pro™ is not designed for use in
areas of medical locations where an explosion hazard may
exist. Explosion hazards may result from the use of
flammable anesthetics, skin cleansing agents or
disinfectants. Great care must be exercised when the system
is used in an oxygen-enriched atmosphere. The atmosphere
is considered to be oxygen-enriched when the room air
contains more than 25% of oxygen or nitrous oxide.
8 EasyOne Pro™ / EasyOne Pro™ LAB
Introduction
Warning
Shock Hazard—
Before using the system, make sure that it is in correct
working order and operating condition. Check the cables
and connectors, in particular, for signs of damage.
Replace damaged cables and connectors immediately,
before use.
Do not expose EasyOne Pro™ to direct sunlight to
prevent system components from reaching inadmissible,
high temperatures. Furthermore, EasyOne Pro™ has no
additional protection against the ingress of humidity.
When disconnecting the device from the power line,
remove the plug from the wall outlet first, before
disconnecting the cable from the device. Otherwise there
is a risk of coming in contact with line voltage by
inadvertently introducing metal parts in the sockets of the
power cord.
Do not use multiple portable socket outlets (MPSO) to
connect the devices to the power line.
Printers operated in the patient vicinity must meet the
requirements of IEC 60601. If they do not, they must be
modified and be connected to earth ground (PE, potential
equalization).
All devices of a system must be connected to the same
power supply circuit. Devices that are not connected to
the same circuit must be electrically isolated when
operated, e.g., with an isolated RS232 interface (this is
not a requirement in the USA).
Devices may be connected to other devices or to parts of
systems only when it has been made certain that there is
no danger to the patient, the operators, or the
environment as a result. In those instances where there is
any element of doubt concerning the safety of connected
equipment, the user must contact the manufacturers
concerned or other informed experts to find out whether
there is any possible danger to the patient, the operator,
or the environment as a result of the proposed
combination of equipment. Standards IEC 60601-1-1/
EN60601-1-1 must be complied with in all cases.
EasyOne Pro™ / EasyOne Pro™ LAB 9
Introduction
Liquids must not be allowed to enter the device or the
sensor. Devices and sensors into which liquids have
penetrated must be immediately cleaned and checked by
a service technician, before they can be reused.
Do not open the device or the sensor. There are no user-
replaceable components inside the device or the sensor.
Do not insert objects of any kind into the device. They
may touch live components and you might suffer an
electric shock, cause fire, or damage the device.
Warning
Patient Hazard—The operator must be trained in the use of
the device.
Patient Hazard—Before performing any tests on patients,
refer to the ATS/ERS Taskforce recommendations (literature
[11] ("Literature" on page 165).
Patient Hazard—Custom configured reports bear the label
Custom Report at the bottom of each page. The user is
responsible for the content and use of all custom configured
reports.
Patient Hazard—Do not touch the accessible contacts of
connectors located at the rear panel and the patient at the
same time.
Patient Hazard, Equipment Damage—Do not modify
EasyOne Pro™ in any way.
Patient Hazard—When used at 230-240 V, 60 Hz equipment
must be connected to a center-tapped 240 V single phase
transformer (US requirement).
Risk of Infection—Follow all cleaning procedures carefully, and
thoroughly inspect the components after they are cleaned and
before each patient is tested. Cleaning residue, particulate
matter, and other contaminates (including pieces of torn or
broken components) in the breathing circuit create a safety
risk to the patient during test procedures. Aspiration of
contaminates can be potentially life-threatening.
Risk of Infection—Proper use of the spirette™ and the DLCO
barriette™/FRC barriette™ provides a reliable infection
barrier. The use of other accessories is not permitted.
Cross Contamination Between Patients—The spirette™ and
the DLCO barriette™/FRC barriette™ are intended for
10 EasyOne Pro™ / EasyOne Pro™ LAB
Introduction
single patient use. Use a new one for each patient to prevent
cross contamination between patients.
Risk of Poisoning—Observe all information provided by the
manufacturers of chemical products required for the use and
care of the product. Always keep these chemical products in
their original containers to avoid any confusion which may
have severe consequences.
RF Interference—Known RF sources, such as cell phones,
radio or TV stations, and two-way radios, may cause
unexpected or adverse operation of this device. Check the
device performance before each use.
Risk to Persons—If the display is broken, avoid contact with
the liquid crystal.
Suffocation Hazard—Dispose of the packaging material,
observing the applicable waste-control regulations. Keep the
packaging material out of children's reach.
Caution
Equipment Damage—Before connecting the device to the
power line, check that the voltage and frequency ratings of
your power line match the values indicated on the device
nameplate.
Equipment Damage—Protect the equipment from viruses,
malware, etc. Always check the USB flash drive for viruses,
before connecting it to the equipment.
Equipment Damage—Do not set up EasyOne Pro™ in the
direct vicinity of a window. Rain, humidity and sunlight may
damage EasyOne Pro™. Do not operate EasyOne Pro™ in
the vicinity of heating appliances (radiators). Do not block air
vents and do not place any objects on the device.
Equipment Damage—Do not drop EasyOne Pro™.
Equipment Damage—For equipment transport, switch off
EasyOne Pro™ and store it in its original packing.
Restricted Sale—U.S. Federal law restricts this device to sale
by or on the order of a physician.
EasyOne Pro™ / EasyOne Pro™ LAB 11
Introduction
EasyOne Pro™ LAB only
Danger
Explosion Hazard—
Ensure that persons working with oxygen have undergone
special training and are aware of the particular properties
of oxygen to guarantee safe handling of oxygen without
accidents. Furthermore, these persons must be familiar
with this operator manual and must have understood its
content.
Do not use hand cream or other skin care products.
Oxygen intensively promotes combustion; therefore,
flammable substances must be kept away from oxygen.
Unintended release of oxygen in confined spaces
increases risk of fire; smoking and open flames are
prohibited. Possible sources of ignition must be
eliminated. Rooms must be well ventilated.
The oxygen inlet must periodically be checked for leaks
(at least once a month).
Use only fittings approved for use with oxygen; these
fittings must be properly connected. All fittings,
downstream lines and devices must be free of oil and
grease.
Connect a pressure relief valve to the pressurized gas
cylinder before opening it! Before connecting the
pressure relief valve, check the connection sleeve of the
pressurized gas cylinder for contamination. Contaminated
connections must be cleaned with a clean cloth. The valve
of the pressurized gas cylinder may be opened only if the
connected fittings are closed. Open the valve of the
compressed gas cylinder very slowly.
12 EasyOne Pro™ / EasyOne Pro™ LAB
Equipment Symbols
0120
Introduction
Observe the information given in the operator manual.
Do not reuse (single patient use).
CE marked per the Medical Device Directive 93/42/EEC of
the European Union.
Product certification for the USA and Canada.
Connection to power line ON (mains power switch).
Connection to power line OFF (mains power switch).
Temperature and humidity sensor.
Potential equalization pin.
Alternating voltage.
Gas inlet for DLCO gas.
Gas inlet for O2 (oxygen).
The number found under this symbol is the date of
manufacture in the YYYY-MM format.
Manufacturer
Type BF applied part
EasyOne Pro™ / EasyOne Pro™ LAB 13
Introduction
This symbol indicates that the waste of electrical and
electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately. Consult
Operator Manual!
Hardware revision.
1.7 Intended Use
The ndd EasyOne Pro™ Respiratory Analysis System is designed for
conducting lung function measurements in general or specialist practices or
in hospitals.
The EasyOne Pro™ Respiratory Analysis System can also be used outside of
the laboratory when performing lung function screenings or measurements
in occupational medicine.
The EasyOne Pro™ Respiratory Analysis System is used to conduct lung
function measurements on adults and children starting at age 4, except
measurements of Diffusing Capacity of the lung based on CO (DLCO), which
can be performed on adults and children starting at age 6.
1.8 Contraindications to Performing DLCO Tests
Do not perform a DLCO test
in the presence of carbon monoxide toxicity
in case of dangerous levels of oxyhemoglobin desaturation without
supplemental oxygen
1.9 Additional Functions of EasyOne Pro™ LAB
EasyOne Pro™ LAB includes the measurement of the FRC (Functional
Residual Capacity) based on the Multiple Breath Nitrogen (N
method. This method is based on washing out the N2 from the lungs, while
the patient breathes 100% oxygen. The analysis of the expired N2 trace is
used to compute the FRC and other parameters like LCI (Lung Clearance
Index) that are used to quantify distribution inhomogeneities of the lung.
The test is based on tidal breathing only and can easily be performed in
adults and children starting at age 4.
14 EasyOne Pro™ / EasyOne Pro™ LAB
) Washout
2
Introduction
A Mains connector
B Power supply unit
C Hard disk
D Storage disk (backup)
EIndustrial standard PC
F PC ports (USB, LAN, etc.)
G Automatic data acquisition
H Sensor for ambient temperature and
humidity
IPump
J Pneumatic system
K Demand valve
LCO sensor
M Molar mass sensor
N Display with touch screen
O Replaceable filter pack
P Gas supply tubing
QDLCO valve
R Motor block
SSensor
T Gas cylinder for DLCO tests
U Oxygen cylinder for FRC test or wall
outlet (EasyOne Pro™ LAB only)
V Oxygen supply unit (EasyOne Pro™
LAB only)
1.10 Components and Functional Description of EasyOne Pro™
Fig. 1-1 EasyOne Pro™, block diagram
EasyOne Pro™ / EasyOne Pro™ LAB 15
Introduction
EasyOne Pro™ consists of a compact main unit and a hand-held flow
sensor S with removable DLCO valve unit Q. The hand-held sensor is
electrically connected to the device. For DLCO tests, a gas supply tube P
delivers gas to the DLCO valve. The sensor measures flow velocity, volume
and molar mass of the gases that the patient inhales and exhales.
The mains connector A connects the device to line power. The gas cylinder T
supplies the medical gas mixture that is required to perform DLCO tests
(normally 0.3% CO, 10% He, 21% O
A temperature and humidity sensor H measures the temperature and
humidity in the examination room.
The device contains an industrial standard PC E (Windows XP embedded)
that performs data acquisition, data analysis and storage of test results.
The user interface for display and control consists of a flat panel display
with touch screen N. If required a keyboard and/or a mouse can be
connected to the PC. A pneumatic system J delivers gas to the patient,
allows flushing of the DLCO gas delivery hose and draws gas samples from
the patient's inspiratory and expiratory breath. The side stream flow used
for gas analysis is driven by a pump I. CO gas is analyzed by a sensor based
on infrared absorption L. A molar mass sensor M based on ultrasound
transit time measurement determines the helium content of the respired air.
The oxygen supply unit V required by the EasyOne Pro™ LAB version is
located on the left side of the device.
Note
EasyOne Pro™ includes the Touch-It Virtual Keyboard developped
by Chessware SA.
in N2).
2
1.11 EasyOne Pro™ Flow Sensor Design and Operation
The ultrasound flow sensor measures the transit time to determine flow
velocity, volume and molar mass of the gas (molecular weight x
concentration). The illustration below explains the measuring principle: two
ultrasound sensors emit very short ultrasound pulses that travel along the
transmission path to the opposite ultrasound transducer. Measuring the
transit times allows the flow velocity to be determined very accurately and
independently of temperature, humidity and molar mass of the gas. Since
the measuring principle is based on a digital measurement technique, the
sensor requires only one single calibration. The sensor calibration does not
change during the sensor's lifetime.
16 EasyOne Pro™ / EasyOne Pro™ LAB
ultrasound sensor 1
ultrasound sensor 2
integrated mouthpiece
Fig. 1-2 Flow sensor
1.12 Test Gas Requirements
DLCO Test Gas
Caution
Patient Hazard, Incorrect Measurements—
Observe local regulations. Use only medical-grade gases, if
required.
Make sure that only ndd-approved gas mixtures are used. If
the gases used do not meet the ndd specifications,
equipment malfunction may occur and the test results may
be incorrect.
Introduction
EasyOne Pro™ / EasyOne Pro™ LAB 17
Gas mixture: 10% helium, accuracy +
10 %; 0.3% carbon monoxide,
accuracy +10 %;18 to 25% oxygen, balance nitrogen
DLCO simulator test require gas mixtures with an accuracy <
Note
You can purchase all necessary gases and cylinders as well
as the fittings from your local ndd dealer. Equipment not
intended for mobile use can also be used with large gas
cylinders.
Use only the supplied original tubing to connect the gas
cylinder to the device.
Use only the original gas supply tube to connect the valve
unit to the device.
2 %.
Introduction
Warning
Improper handling of gas cylinders represents a major risk to
persons and the environment. The relevant regulations must
be observed without exception. Protect the gas cylinders
from falling. The content and fill level must be clearly visible
at all times. Valves, fittings, connections and tubing must be
free of oil and grease. Have the cylinder inspected regularly
by an official test authority. The user is liable for any
damage. Close the main valve whenever the gas cylinder is
not in use!
FRC Gas (100% O2), EasyOne Pro™ LAB only
Medical grade oxygen; 100 % O2. From compressed gas cylinders or the
hospital's oxygen supply system.
Note
When using the wall outlet, please observe the hospital's inhouse instructions and requirements.
18 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
2 Start-up and Initial Preparation
2.1 Unpacking, Environmental Conditions
Transport Damage
Upon arrival, immediately check that the shipment is complete and
undamaged. If you have a complaint, promptly notify the shipping agent
and your local ndd dealer.
Check each of the following items:
the housing
the sensor and its connection cable
the valve unit including the overpressure valves and the one-way
valve
the gas supply tube
the power cord
the gas cylinder fittings.
Cleaning Before Initial Use
EasyOne Pro™ does not require cleaning before its first use.
The gas supply tube and the valve unit are cleaned before shipping, but not
disinfected. These parts can be thoroughly cleaned as described in chapter
"Hygiene, Cleaning, Maintenance, Disposal" on page 89.
Ambient Conditions
Excessive amounts of dust, lint, and miscellaneous clutter around the
instrument could result in malfunctions due to internal tubing blockages,
overheating of components, clogged ventilation ports, etc.
EasyOne Pro™ can be operated under the following ambient conditions:
temperature +5 to +40 °C (41 to 104 °F)
(LAB: 10 to 40 °C (50 to 104 °F))
relative humidity 15 to 95%, no condensation
(LAB: 30 to 75%, no condensation)
atmospheric pressure 700 to 1060 hPa.
Note
Also observe the information given in section
"Electromagnetic Compatibility (EMC)" on page 138.
EasyOne Pro™ / EasyOne Pro™ LAB 19
Start-up and Initial Preparation
abc d fe
a Sensor holder, extendible
b Sensor cable connection
c Connection for gas supply tube to
sensor
dON/OFF switch
eTouch stylus
f Sensor (see Fig. 2-3)
2.2 Equipment Description
Fig. 2-1 EasyOne Pro™
20 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
gqlhi mn pj k o r
g USB ports (keyboard, mouse, printer)
h Memory card slot cover (Flash card,
see "Data Backup on Memory Card" on
page 91)
i LAN ports (printer)
j Monitor
k Serial RS232 ports
l Connection for temperature and
humidity sensor
m Connection for tube from DLCO gas
cylinder
n Potential equalization pin
o Screw to secure the filter pack (must be
removed before the filter can be
replaced)
pNameplate
q Mains connector, mains power switch
r Connection for O
2
gas supply system
(EasyOne Pro™ LAB only)
Fig. 2-2 EasyOne Pro™, rear panel
EasyOne Pro™ / EasyOne Pro™ LAB 21
Fig. 2-3 Sensor
st u w xv
s Coupling ring for the gas supply tube
t Overpressure valves
uOne-way valve
v DLCO barriette™ or for LAB FRC
barriette™
w Motor block, release button
xspirette™
Start-up and Initial Preparation
2.3 Preparing the Device
Connect the sensor cable to the device.
Fig. 2-4 Connecting the sensor cable
22 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
Connect the gas supply tube to the valve unit:
Note
Be sure to connect the side of the tube with the colored
coupling ring to the device.
Slip tubing connector onto connection at sensor
Screw coupling ring tight.
Fig. 2-5 Connect gas supply tube to valve unit
Connect the other end of the gas supply tube to the device and tighten
the coupling ring.
Fig. 2-6 Connecting the gas supply tube to the device
EasyOne Pro™ / EasyOne Pro™ LAB 23
Start-up and Initial Preparation
a
Attach the valve unit to the sensor (aligning the arrow) and advance the
valve unit until you hear it click into place (press button a to unlock).
Note
The valve unit must be mounted on the sensor only for DLCO
and FRC tests. All other tests are performed without the valve
unit.
Fig. 2-7 Attaching the valve unit to the sensor
Pull out the sensor holder on the left side of the device (a, Fig. 2-1) and
place the sensor in the holder.
If you are working with the sensor stand (optional accessory), you can
position the sensor such that the patient is not required to hold it during the
tests.
Using the clamp, screw the sensor stand to the table top.
Open the catch and insert the sensor.
Close the catch.
Fig. 2-8 Inserting the sensor in its stand
24 EasyOne Pro™ / EasyOne Pro™ LAB
Connect the temperature and humidity sensor.
Fig. 2-9 Temperature and humidity sensor
2.4 Gas Supply
Start-up and Initial Preparation
Note
Ensure that the sensor is exposed to the normal room
temperature and that it will not measure incorrect values
because of exposure to a draft from the blower, to lamps or
direct sunlight.
DLCO Gas
Note
It is very important to comply with the information given in
chapter "Test Gas Requirements" on page 17.
The gas cylinder fittings (pressure relief valve) must meet the
following minimum requirements:
input pressure on primary side: 150 to 300 bar (depending on
max. cylinder pressure)
output pressure on secondary side: 0 to 6 bar
flow rate: 6 L/s minimum
You can purchase all necessary gases and cylinders as well
as the fittings from your local ndd dealer.
Equipment not intended for mobile use can also be used
with large gas cylinders.
Use only the supplied original tubing to connect the gas
cylinder to the device.
Use only the original gas supply tube to connect the valve
unit to the device.
EasyOne Pro™ / EasyOne Pro™ LAB 25
Start-up and Initial Preparation
a b dc e
a Gas cylinder main valve
b Manometer, primary side
c Pressure relief valve, secondary side
d Manometer, secondary side
e Port for EasyOne Pro™ connection tube
(DLCO gas)
Warning
Improper handling of gas cylinders represents a major risk to
persons and the environment. The relevant regulations must
be observed without exception. Protect the gas cylinders
from falling. The content and fill level must be clearly visible
at all times. Valves, fittings, connections and tubing must be
free of oil and grease. Have the cylinder inspected regularly
by an official test authority. The user is liable for any
damage. Close the main valve whenever the gas cylinder is
not in use!
Check that the gas meets ndd specifications.
Check that the main valve a and the pressure relief valve c are closed.
Fig. 2-10 Gas cylinder fittings
Connect the tube to the DLCO gas port on EasyOne Pro™: push the tube
onto the stud, exerting sufficient force to overcome the initial resistance;
then advance the tube as far as it will go.
Note
It is important to slide the tube at least 19 mm onto the stud.
To remove the tube, push the bushing ring back and pull the
26 EasyOne Pro™ / EasyOne Pro™ LAB
tube off the stud.
Start-up and Initial Preparation
If the tube end shows signs of mechanical damage
(grooves), cut off the damaged portion.
Fig. 2-11 Connection for tube from DLCO gas cylinder
Connect the other end of the tube to the pressure relief valve c.
Open the main valve a of the gas cylinder completely.
Slowly open the pressure relief valve c and set the manometer d to a
secondary pressure of 4 to 5 bar.
Note
A DLCO overpressure valve that opens at 7.5 bar is integrated
in the device. If you select a higher secondary pressure, the
overpressure valve will open and gas will escape.
Exchange the gas cylinder if the primary pressure drops
below 10 bar!
Warning
Be sure not to confuse the DLCO gas inlet and the FRC gas
inlet.
EasyOne Pro™ / EasyOne Pro™ LAB 27
Start-up and Initial Preparation
a b dc e
a Gas cylinder main valve
b Manometer, primary side
c Pressure relief valve, secondary side
d Manometer, secondary side
e Port for EasyOne Pro™ LAB connection
tube (FRC gas)
FRC Gas (100% O2), EasyOne Pro™ LAB only
Medical grade oxygen is used for FRC measurements with EasyOne Pro™
LAB.
Secondary pressure: 3 bar
Flow: >
0.7 l/s (at 3 bar)
Warning
Improper handling of gas cylinders represents a major risk to
persons and the environment. The relevant regulations must
be observed without exception. Protect the gas cylinders
from falling. The content and fill level must be clearly visible
at all times. Valves, fittings, connections and tubing must be
free of oil and grease. Have the cylinder inspected regularly
by an official test authority. The user is liable for any
damage. Close the main valve whenever the gas cylinder is
not in use!
Check that the main valve a and the pressure relief valve c are closed.
Fig. 2-12 Gas cylinder fittings
28 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
Connect the tube to the FRC gas inlet at the EasyOne Pro™ LAB (Fig.
2-13): push the tube onto the stud, exerting sufficient force to overcome
the initial resistance; then advance the tube until the stop.
Note
It is important to slide the tube at least 19 mm onto the stud.
To remove the tube, push the bushing ring back and pull the
tube off the stud.
If the tube end shows signs of mechanical damage
(grooves), cut off the damaged portion.
Fig. 2-13 Connection for tube from FRC gas cylinder
Connect the other end of the tube to the pressure relief valve c.
Open the main valve a of the gas cylinder completely.
Slowly open the pressure relief valve c and set the manometer d to a
secondary pressure of 3 bar.
Danger
Explosion Hazard—An FRC overpressure valve that opens at
5 bar, is integrated in the device. If you select a higher
secondary pressure, the overpressure valve will open and
gas will escape.
Note
Exchange the gas cylinder if the primary pressure drops
below 10 bar!
EasyOne Pro™ / EasyOne Pro™ LAB 29
Start-up and Initial Preparation
2.5 Connecting the Keyboard and the Mouse
EasyOne Pro™ is equipped with a touch screen display and can thus be
operated without a keyboard or a mouse. However, if you prefer working
with a keyboard and a mouse, connect them to a USB port (g, Fig. 2-2).
2.6 Connecting the Printer
Depending on the printer used, connect it to one of the USB ports (g, Fig.
2-2) or to one of the LAN ports i.
Note
Preinstalled and compatible printer models (please contact
your ndd dealer to find out about other options):
HP Deskjet 6988
HP Deskjet 6940
HP Officejet H470
HP Universal Printing PCL5 (see below).
In the main menu, select Utilities -> Configuration -> Printer.
Open the printer list and select the printer.
Fig. 2-14 Printer tab
Printing with HP Universal Printing PCL5 (network printer)
In the drop-down list, select "HP Universal Printing PCL" and confirm with
OK.
30 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
Select the test to print.
Fig. 2-15 Test selection
Press Print: the printer window will appear.
Fig. 2-16 Printer window
Select Search for Network printers....
Fig. 2-17 Printer window
Select the printer to use.
EasyOne Pro™ / EasyOne Pro™ LAB 31
2.7 Power
Start-up and Initial Preparation
Caution
Equipment Damage—Before connecting the device to the
power line, verify that the ratings of your local power line are
those indicated on the device nameplate.
Warning
Shock Hazard—Do not use this equipment unless it is
properly connected to earth ground.
Use only the original ndd power cord supplied with the
device.
If the device is used within a medical system, it must be
connected with the room's central potential equalization
system (pin a, Fig. 2-18).
Using improperly grounded equipment could result in
serious injury or death and severe damage to the equipment
and interconnected equipment. Grounding reliability and
leakage current suppression can only be assured when the
power connectors are properly connected to earth-grounded
receptacles.
Note
EasyOne Pro™ meets the safety requirements of UL, NFPA,
LACTL, CSA, TUV, BSI, and IEC-60601 for leakage currents.
The device is checked for leakage current before shipment.
The ndd service representative (or distributor representative)
will assist hospital personnel in verification, if requested.
Leave the mains power switch c on all the time and use the
ON/OFF switch on the front panel to switch the device on and
off. Turn off power with the mains power switch only when
the device will not be used for some time.
Connect the power cord to connector b, then plug it into the wall outlet.
32 EasyOne Pro™ / EasyOne Pro™ LAB
Fig. 2-18 Mains connection
acb
a Potential equalization pin
b Mains connector
c Mains power switch
Start-up and Initial Preparation
2.8 Inserting the One-Way Valve, DLCO barriette™/FRC barriette™ and spirette™
One-Way Valve, DLCO barriette™
EasyOne Pro™ / EasyOne Pro™ LAB 33
Note
The valve unit is only required for DLCO and FRC tests. All
other tests are performed without the valve unit. The device
is to be operated only with the original ndd DLCO
barriette™.
Warning
Cross Contamination Between Patients—The DLCO
barriette™ is intended for single patient use. Use a new one
for each patient to prevent cross contamination between
patients.
Start-up and Initial Preparation
Attach the one-way valve to the valve unit (aligning the arrows) as shown
in Fig. 2-19 and turn it clockwise as far as possible.
Fig. 2-19 Attaching the one-way valve
Insert the DLCO barriette™ in the one-way valve (aligning the arrows) as
shown in Fig. 2-20 and check that it sits tight.
Fig. 2-20 Inserting the DLCO barriette™
34 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
FRC barriette™ (EasyOne Pro™ LAB only)
Note
The FRC barriette™ is required only when also FRC tests will
be performed with the EasyOne Pro™ LAB. If the EasyOne
Pro™ LAB is used for DLCO testing, the DLCO barriette™ will
also have to be attached here.
The device is to be operated only with the original ndd FRC
barriette™.
Warning
Cross Contamination Between Patients—The FRC barriette™
is intended for single patient use. Use a new one for each
patient to prevent cross contamination between patients.
Fig. 2-21 Inserting the FRC barriette™
EasyOne Pro™ / EasyOne Pro™ LAB 35
spirette™
Start-up and Initial Preparation
Note
The device is to be operated only with the original ndd
spirette™.
Warning
Cross Contamination Between Patients—The spirette™ is
intended for single patient use. Use a new one for each
patient to prevent cross contamination between patients.
Tear open the plastic bag containing the spirette™ and fold the bag back
so that you can insert the spirette™ in the flow sensor. Ensure that the
plastic bag protects the mouthpiece of the spirette™ until you hand the
flow sensor over to the patient.
This approach not only ensures perfectly hygienic conditions, it also keeps
the spirette™ closed for subsequent setting of the baseline.
Insert the spirette™ - as shown in the illustration - into the flow sensor
as far as possible. When doing this, please ensure that the arrow on the
spirette™ is lined up with the arrow on the flow sensor.
You remove the spirette™ by pushing it out of the sensor from below.
Fig. 2-22 Inserting the spirette™
36 EasyOne Pro™ / EasyOne Pro™ LAB
Start-up and Initial Preparation
2.9 Switching the Device On, Functional Test
Open the main valve of the gas cylinder(s) completely.
Check the secondary pressure: for DLCO gas , it must be 4 to 5 bar, and
for FRC gas, it must be 3 bar (EasyOne Pro™ LAB only).
Turn on the mains power switch on the rear panel of the device.
Turn on the device with the power button: the green indicator is
illuminated.
Fig. 2-23 Power button
After a short start-up phase, the initial screen will be displayed.
Note
If the initial screen appears and no error messages display, the
device is in perfect operating condition.
EasyOne Pro™ / EasyOne Pro™ LAB 37
cfgia hbde j
a Selected patient
b Practice, office, hospital (see "General
Tab " on page 100 for details about
entering the data)
c Click to select a patient or add a new
patient
dClick to perform a test
e Click to review the results from
previous tests
f Click to view the setup screen
g Sensor status (sensor icon, if sensor is
connected)
h Click to display the keypad
i Help button
j Click to quit the program
Fig. 2-24 Initial Screen
Start-up and Initial Preparation
Note
EasyOne Pro™
activate a button by touching it on the display.
(h, Fig. 2-24) is used to display and remove the touch
keypad that allows you to make all entries.
Before the first test, you should follow the instructions given
in "System Settings" on page 99 and
enter the practice/office or hospital name
select the language
select the test types and parameters
Note
After each exchange of the gas cylinder, check whether the
gas concentration in the program corresponds to the
specifications on the cylinder
38 EasyOne Pro™ / EasyOne Pro™ LAB
is equipped with a touch screen display. You
. Follow these steps:
Start-up and Initial Preparation
Select Utilities -> Configuration -> Test -> DLCO.
Compare the displayed values with the data on the gas cylinder.
Close the tab with OK.
Fig. 2-25 DLCO tab
EasyOne Pro™ / EasyOne Pro™ LAB 39
Performing a Test
a cde ibfhg j
k
a Selected patient
b Bar cursor for patient selection
c Click to add a new patient
d Click to perform a test with the selected
patient
e Click to view the selected patient's test
results
f Click to edit the selected patient's data
g Click to delete the data of the selected
patient
h Help button
i Filter Last Name; by entering one or
more letters, you limit the number of
patients to those meeting the filter
criteria
j Additional parameters
k Back to main menu
3 Performing a Test
Note
Before performing a test, you should do the following:
select the test details
(e.g. only expiratory or inspiratory and expiratory FVC
measurement, predicted value calculation, etc., see "Test Tab" on
page 105)
select a patient from the database as described below, or enter a
new patient in the database. As an alternative you can perform a
Quick Test which will be saved to the database with an
automatically assigned ID (e.g. Q_0033) (see "Quick Test" on
page 59).
3.1 Selecting/Adding a Patient
Click Select Patient.
The patient list will be displayed.
Fig. 3-1 Patient list
40 EasyOne Pro™ / EasyOne Pro™ LAB
Selecting the Patient
The displayed patients can be sorted by
Patient ID
Last Name
First Name
Date of Last Test.
To do so, click on the appropriate title in the column headers.
To search for a specific patient, you enter the first letter(s) of the
patient's last name at h.
You select a patient by clicking in the corresponding line of the list: the
bar cursor highlights the selected patient. At the same time, the
patient's name appears at a.
Note
Click to view the patient data. Click again to close
the window.
Performing a Test
Fig. 3-2 Window showing patient data
EasyOne Pro™ / EasyOne Pro™ LAB 41
Adding a New Patient
a b c
Click New Patient.
Enter a patient ID and press the TAB key or the Enter key (click to
enter an automatically generated ID).
Enter the last and first names in the same way.
Click a (Fig. 3-3) to select the gender and press the TAB key.
Also, select the ethnic origin b.
Enter the date of birth, height and weight.
Note
The information regarding gender, age, height, weight and
ethnic origin must be correct, because it is used to calculate
the predicted values and to interpret the acquired data.
Additional information can be entered on the Smoking
History (see Fig. 3-4), History and Comment tabs c.
Close the window with OK.
The patient list will be displayed and the new patient is selected.
Performing a Test
Fig. 3-3 Patient data window
42 EasyOne Pro™ / EasyOne Pro™ LAB
Fig. 3-4 Smoking History tab
Merging a Patient’s Data Records
You can merge data records for one and the same patient, for example, if
they were acquired with different tests or if different spellings of the patient's name exist. Use Drag & Drop (right mouse button) to merge data
records.
Performing a Test
Fig. 3-5 Merging a patient’s data records
EasyOne Pro™ / EasyOne Pro™ LAB 43
3.2 Selecting a Test
The test selection screen will appear either directly after entry of the patient
data or it can be accessed from the initial screen with Perform Test.
Fig. 3-6 Test selection screen
Note
If the unit selected is EasyOne (see "Device Tab"
on page 111), you will see Fig. 3-7.
Observe the instructions shown on the monitor screen and
on the display of the EasyOne when performing tests and
the subsequent synchronization.
Refer to the EasyOne tab (see "EasyOne Tab" on page 112) for configuration
options.
Performing a Test
Fig. 3-7 Selection screen when the selected device is EasyOne
44 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
bc e i jaf kdh
g
a Selected test parameters
b Predicted values, past test results of
the patient
c Flow-volume loop area
d Start button
eScaling
f Displayed curve selection: best trial,
best trial and pre trial, all trials
g Show/hide the animation program for
children (incentive)
h Show/hide expanded parameter list
i Volume-time curve area
j Test information and system
interpretation area
k Click to perform a new test, to view the
patient's test list, to select a new
patient and to print a test
3.3 Forced Vital Capacity (FVC/FVL)
Click FVL (ex/in).
The acquisition screen will be displayed.
Note
The scale for the flow-volume loop depends on the selected
test (only expiratory or inspiratory and expiratory, tidal
breathing yes/no).
Expiratory FVC Measurement
Fig. 3-8 Expiratory FVC acquisition screen
EasyOne Pro™ / EasyOne Pro™ LAB 45
Preparations
The patient should be relaxed and should not wear tight clothing. The
patient may stand or sit during the test. In exceptional cases, the patient
may feel dizzy when performing the test. Therefore, watch your patients
closely, if they are standing for the test.
Performing a Test
Explain that the purpose of the test is to determine how much air a person’s
lungs can hold and how quickly that air can be expelled. Since the
spirometry test requires active participation by the patient, it is very
important to explain the test maneuver:
take the spirette™ into the mouth with the lips sealing around the
spirette™, taking care not to block its opening with the tongue or bite
down excessively on the spirette™
breathe calmly
fill lungs completely
exhale as hard and fast as possible
continue blowing out until the lungs are completely empty
breathe in again.
If you perform spirometry tests with EasyOne Pro™ on patients for the first
time, you should practice testing yourself and others prior to testing
patients. You will learn to recognize the cause of problems by interpreting
the Quality Messages displayed by the program after each effort and how to
avoid these problems. After a poor effort explain to your patient how to
improve the maneuver.
Fig. 3-9 Patient using the sensor
Caution
Risk of Injury—Pulmonary function tests require maximum
effort on the part of the patient and may lead to dizziness.
Risk of Infection—The spirette™ is designed for single use.
Use a fresh spirette™ for each new patient.
Risk of Infection—Clean the nose clip after each patient.
46 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
Measurement
Insert the new spirette™ in the sensor.
Attach the nose clip to the patient.
Press Start.
The device advises you to keep the spirette™ closed until the test start
prompt is displayed. This is necessary to set the baseline correctly.
Note
ndd recommends leaving the spirette™ packaging in place
until after the baseline has been set.
Block off the spirette™ on one end and confirm the message with OK.
When the start test prompt is displayed, hand the sensor over to your
patient and instruct him or her to perform the maneuver as explained
earlier.
Note
If the "Manual Test Stop" option was selected in the
configuration (see "Test Tab" on page 105), the operator
must terminate the measurement by clicking the Test End
button or by pressing the space bar or the Enter key.
During the test, you will see the flow-volume loop and the volume-time
curve on the display. All curves and measured values will be displayed after
the test.
EasyOne Pro™ / EasyOne Pro™ LAB 47
Fig. 3-10 Acceptable FVC test
aabef gc d
aPredicted values
bTest results
c Area for review comments
d Click to perform a post-test (see
"Bronchodilation (Post-Tests)" on
page 52)
e Test information, system interpretation
f Click for a retrospective test evaluation
or to expand the parameter list (see
"Retrospective Test Assessment,
Entering Comments" on page 82)
g Click to view more test information and
system interpretation statements
Performing a Test
In order to assess the patient's pulmonary function, it is necessary to
achieve acceptable test quality. The test quality depends on the cooperation of the patient which, in turn, depends on the quality of the
physician's instructions. EasyOne Pro™ incorporates an automatic quality
control function. This function analyzes the test quality and displays a
message to inform you as to whether the maneuver was acceptable or not
(see "System Interpretation" on page 82). This function also allows the
physician to improve patient instructions.
48 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
a cb
a Quality grade
b Click to perform a post-trial (see
"Bronchodilation (Post-Tests)" on
page 52)
c Area for review comments
When three acceptable maneuvers have been performed, the message
Session complete!
appears. If, even after repeated attempts, it is not
possible to obtain an adequate number of good maneuvers, you should take
a break, depending on how the patient feels, or stop the measurement. Even
after a break, the measurement results remain stored.
Click Add Trial for each subsequent spirometry maneuver.
A review comment can be entered in area c or the results can be edited (do
not forget to give the reviewer's name).
When three acceptable tests have been performed, the message Session
complete! appears and a quality grade from A (optimal) to F a is displayed.
Fig. 3-11 Acquisition screen after three acceptable, expiratory FVC tests
Note
If FEV6 is selected (instead of FVC), the measurement will
stop automatically after 6 seconds.
EasyOne Pro™ / EasyOne Pro™ LAB 49
%Pred Graph
a b c
The %Pred graph is a three-segment bar. The left segment a indicates a
value below the lower limit of normal, the middle segment b represents a
value between the lower limit and the predicted value and the right
segment c indicates a value above the predicted value. FVC, FEV1 and
FEV1/FVC are displayed in color, all other parameters are grey.
Fig. 3-12 %Pred graph
Adding a Spirometry Trial
If you would like to add trials to a previous test, e.g. if the patient needed a
break or if other patients were tested in between, please proceed as
follows. Remember, however, that it is only possible to add a trial to a
previous test that was performed on the same day.
Select the patient.
Click Perform Test.
Select the test, e.g. FVC.
A menu will appear.
Performing a Test
Fig. 3-13 Menu
Click Add Trial or Add Post.
The acquisition screen will be displayed.
Perform the new spirometry maneuvers.
50 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
a bc d e
f
a Conversion factors
b Box for entry of the humidity
c Box for entry of the ambient temperature
d Box for entry of the altitude (atmospheric
pressure)
e Click to recalculate the BTPS factor (if the
ambient conditions were modified)
f Click to confirm and accept the values
FVL Test (inspiratory and expiratory measurement)
Ambient Conditions
The ATPS values (Ambient Temperature Pressure Saturated = spirometer
conditions) of inspiratory measurements must be converted to BTPS values
(Body Temperature Pressure Saturated = body conditions). For this
conversion, the system needs the following data:
relative humidity
room temperature
atmospheric pressure or altitude.
Before the inspiratory test can be started, a window pops up with these
data. Check the data. For the pending test you can now edit the data, if
necessary, or confirm them, if they are correct.
Fig. 3-14 Window showing the ambient conditions
Edit the values, if necessary, and click Confirm >> to close the window.
Warning
Erroneous Measurement Results—Incorrect entries may lead
to erroneous test readings and incorrect system
interpretations. The specified measuring accuracy is ensured
only when all entries are correct.
EasyOne Pro™ / EasyOne Pro™ LAB 51
The inspiratory and expiratory FVL test acquisition screen appears.
Measurement
Prepare the patient (see "Preparations" on page 45) and explain the test
maneuvers to him or her:
take the spirette™ into the mouth with the lips sealing around the
spirette™, taking care not to block its opening with the tongue or bite
down excessively on the spirette™
breathe calmly
fill lungs completely
exhale as hard and fast as possible
continue blowing out until the lungs are completely empty
inhale as hard and fast as possible.
Conduct the tests as described in section "Measurement" on page 47.
Note
The volume-time curve (Fig. 3-16) does not display the
forced inspiration at the end of the maneuver.
Bronchodilation (Post-Tests)
The Post test is usually performed to determine the patient's response to
bronchodilating asthma medication. This is done by administering a
bronchodilator to the patient after he or she has performed a spirometry
test (Pre-Test). Approximately 10 to 20 minutes after the medication (when
bronchodilator shows effect, refer to medication labelling) a second
spirometry test is performed. After the test the Pre and Post results are
compared. Post tests can only be added to previous tests performed on the
same day.
Select the patient.
Select the test, then click Add Post to close the window.
Performing a Test
52 EasyOne Pro™ / EasyOne Pro™ LAB
The window with the patient's existing tests appears. With (Fig. 3-15
left) you display the detailed results of the Pre tests (Fig. 3-15 right).
Fig. 3-15 Detailed test results
Conduct the tests as described in section "Measurement" on page 47.
As soon as three acceptable trials have been performed, the message
Session complete! appears and a quality grade from A (optimal) to F is
displayed (see "Quality Messages and Quality Grades" on page 72).
Performing a Test
Fig. 3-16 Acquisition screen after three acceptable post-trials
EasyOne Pro™ / EasyOne Pro™ LAB 53
Animation Program for Children
An animation program for children is available for FVC, FVL and SVC tests.
You can choose between two animations: Balloon and Monkey. When the
animation program is activated, we recommend disabling the manual test
stop and working with the automatic test stop (see "General Tab" on
page 100).
Performing a Test
Fig. 3-17 Balloon animation program for children, test start, successful test
Fig. 3-18 Monkey animation program for children, test start
The Monkey animation can be viewed in full-screen mode .
54 EasyOne Pro™ / EasyOne Pro™ LAB
3.4 Vital Capacity (SVC)
Slow vital capacity measurements determine the vital capacity, starting
from tidal breathing. (You can configure the device for direct measurement
of the vital capacity, i.e., without initial tidal breathing (see "SVC Tab" on
page 108). For this test type, too, the ATPS values (Ambient Temperature
Pressure Saturated = spirometer conditions) must be converted to BTPS
values ( Body Temperature Pressure Saturated = body conditions) (see
"Ambient Conditions" on page 51).
After three acceptable trials, the message Session complete! appears.
Select the patient (see "Selecting/Adding a Patient" on page 40).
Prepare the patient (see "Preparations" on page 45) and explain the test
maneuvers to him or her:
take the spirette™ into the mouth with the lips sealing around the
spirette™, taking care not to block its opening with the tongue or bite
down excessively on the spirette™
breathe calmly in and out
when the start test prompt appears, take a maximum inspiration
followed by an immediate, but unhurried, exhalation.
Select SVC.
The slow vital capacity acquisition screen appears.
Performing a Test
EasyOne Pro™ / EasyOne Pro™ LAB 55
Performing a Test
a b c e hd f
g
a Selected test parameters
bPredicted values
c Volume-time curve area
d Start button
e Test information and system
interpretation area
f Click for a retrospective test evaluation
or to expand the parameter list (see
"Retrospective Test Assessment,
Entering Comments" on page 82)
g Click to view additional information
h Click to perform a new test, to view the
patient's test list, to select a new
patient and to print a test
Fig. 3-19 Slow vital capacity acquisition screen
Conduct the tests as described in section "Measurement" on page 47.
56 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
When three acceptable trials have been performed, the message Session
complete! appears and a quality grade from A (optimal) to F is displayed
(see "Quality Messages and Quality Grades" on page 72).
Fig. 3-20 Acquisition screen after three acceptable SVC trials
3.5 Maximum Voluntary Ventilation (MVV)
In these tests, the maximum ventilation volume over an uninterrupted
period of 12 seconds is measured. For this test type, too, the ATPS values
(Ambient Temperature Pressure Saturated = spirometer conditions) must
be converted to BTPS values ( Body Temperature Pressure Saturated = body
conditions) (see "Ambient Conditions" on page 51).
Select the patient (see "Selecting/Adding a Patient" on page 40).
Prepare the patient (see "Preparations" on page 45) and explain the test
maneuvers to him or her:
take the spirette™ into the mouth with the lips sealing around the
spirette™, taking care not to block its opening with the tongue or bite
down excessively on the spirette™
when the test start prompt is displayed, breathe in and out as deeply
and as fast as possible over a period of 12 seconds.
Select MVV.
The MVV acquisition screen appears.
EasyOne Pro™ / EasyOne Pro™ LAB 57
Fig. 3-21 MVV acquisition screen
a b c e hd f
g
a Selected test parameters
bPredicted values
c Volume-time curve area
d Start button
e Test information and system
interpretation area
f Click for a retrospective test evaluation
or to expand the parameter list (see
"Retrospective Test Assessment,
Entering Comments" on page 82)
g Click to view additional information
h Click to perform a new test, to view the
patient's test list, to select a new
patient and to print a test
Performing a Test
Conduct the tests as described in section "Measurement" on page 47.
Fig. 3-22 Acquisition screen after two acceptable MVV tests
58 EasyOne Pro™ / EasyOne Pro™ LAB
3.6 Quick Test
You have the option to perform a quick test without entering patient data.
When Quick Test is selected, no predicted values are available, because
they are calculated on the basis of the patient data.
In the main menu, select Perform Test.
A menu will appear.
Fig. 3-23 Menu
Click Quick Test and perform the test as usual.
Performing a Test
Note
It is not possible to edit the predicted values retrospectively
once measurements have been taken.
The Quick Test feature is not available for DLCO tests.
3.7 CO Diffusing Capacity (DLCO)
Note
Before conducting the DLCO test, the valve unit must be
attached to the sensor (see Fig. 2-7). Furthermore, a new
barriette™ and, in case of a new patient, a new spirette™
must be inserted (see "Inserting the One-Way Valve, DLCO
barriette™/FRC barriette™ and spirette™" on page 33).
Before performing the first DLCO test, check that the valve
unit is properly attached and that the metal coupling ring of
the motor is tight.
Before performing a DLCO test, you should measure the vital
capacity.
It is recommended to perform two DLCO tests. The pause
between the two tests must be at least 4 minutes. However,
do not perform more than five consecutive DLCO tests on
one patient (ATS/ERS Taskforce recommendations, literature
[11] ("Literature" on page 165).
Select the patient (see "Selecting/Adding a Patient" on page 40).
EasyOne Pro™ / EasyOne Pro™ LAB 59
Performing a Test
Attach the nose clip to the patient and explain the test maneuvers to him
or her:
Select DLCO.
In the BTPS window, confirm the values for relative humidity,
temperature and atmospheric pressure with Conf irm.
Check that the patient sits fully upright and wears the nose clip.
Instruct the patient to hold the sensor straight (not at an angle) in front of
his or her mouth without taking the spirette™ into the mouth yet.
Fig. 3-24 shows the patient during a test, using the sensor stand (optional
accessory).
Fig. 3-24 Patient using the sensor (with optional stand)
Press Start on the acquisition screen. EasyOne Pro™ will automatically
complete a start-up routine in about 15 seconds.
Initialization
Test preparation
Tidal breathing
When you see the message Start tidal breathing, instruct the patient to
take the sensor into the mouth with the lips sealing around the
spirette™ and to start the tidal breathing maneuver.
After 3 or 4 breaths, the Activate button appears. Now instruct the
patient to fully exhale.
60 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
During exhalation, press the Activate button: the valve will automatically
close at the end of exhalation. it is also possible to manually close the
valve by pressing the Manual Close button.
Now instruct the patient to fully inhale (the patient is expected to inhale
85% of their vital capacity within 2 to 4 seconds) and then hold their
breath for 10 seconds.
After the 10 seconds, the valve opens and the patient is required to
exhale quickly, but avoiding forced breathing, and continue tidal
breathing until the test stops.
After a successful test, the message Good effort will be displayed.
EasyOne Pro™ / EasyOne Pro™ LAB 61
Performing a Test
a bc de jk l mf
g
h i
a Tidal breathing
b Complete exhalation
c Holding breath for 10 seconds
d Collection bar (its width depends on
the selected sampling volume m)
e Complete exhalation
f Keys to expand the curve (to check the
collection bar for artifacts)
g Click to show/hide more curves (mouth
pressure, flow)
h Box for comments (touch to display the
keypad)
i Click to show and hide control buttons
for the collection bar
j Click to reset the collection bar
k Click to move the collection bar to the
right
l Click to adjust the DLCO measurement
(see "Introduction to Adjustment of
DLCO Measurements" on page 130)
m Click to select the sampling volume
Fig. 3-25 DLCO test
62 EasyOne Pro™ / EasyOne Pro™ LAB
The collection bar identifies the range that was analyzed.
With the + button f, you can expand the curve to check the collection bar
range for artifacts (click - to reset the bar to its original width).
Performing a Test
With Collection Bar i you can show and hide control buttons for the
collection bar (j, k, m).
With > k you can move the collection bar to the right. The resulting, new
values will immediately be calculated and displayed.
With I<< j you return the collection bar to its original position.
The text box h provides space for comments. A keypad will be displayed as
soon as you touch the area.
You can double-click on a point in the curve windows to hide a curve. The
curve reappears when you double-click once more.
EasyOne Pro™ / EasyOne Pro™ LAB 63
Performing a Test
3.8 FRC Test (EasyOne Pro™ LAB only)
FRC measurement is based on the nitrogen (N2) washout method where N2
is washed out from the lungs while the patient breathes 100% oxygen. The
test is performed during tidal breathing within the range indicated at a (Fig.
3-26). After a (configurable) number of breaths, the measurement starts
automatically or it can be started manually with the Activate button.
Note
Before conducting the FRC test, the valve unit must be
attached to the flow sensor (see Fig. 2-7). Furthermore, a new
FRC barriette™
rette™
must be inserted (see "Inserting the One-Way Valve,
DLCO barriette™/FRC barriette™ and spirette™" on page 33).
Before performing the first FRC test, check that the valve unit is
properly attached and that the metal coupling ring of the
motor is tight.
Inform patients that they may experience a feeling of dryness
during inhalation. Also, they will hear oxygen escape during
the washout phase.
There is a manual mode and an automatic mode, see "FRC
(mbw) Tab" on page 110.
The patient wears a nose clip during the measurement and the
lips must seal around the mouthpiece to prevent ambient air
from being inhaled.
Attach the FRC barriette™ (see "FRC Test (EasyOne Pro™ LAB only)" on
page 64).
Select the patient (see "Selecting/Adding a Patient" on page 40).
Select the test with FRC.
The FRC test acquisition screen appears.
Explain the test maneuver to the patient and prepare him or her for the
test:
attach the nose clip
take the spirette™ into the mouth with the lips sealing around the
spirette™ , taking care not to bite down excessively on the spirette™
sit upright
during the test, the patient should breathe quietly and steadily. The
respiratory flow should not exceed the displayed range (a , Fig. 3-26).
In automatic mode, the test starts automatically after the "Number of
breaths before test start" and ends automatically when the measured concentration drops repeatedly below the limit of 2 % (as configured under
"FRC (mbw) Tab" on page 110).
and, if a new patient is tested, a new
spi-
64 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
a b c ed
a Tidal breathing
b Measuring curve
cTest results
dEnter comment
e Tracer curve (logarithmic
representation, see "FRC (mbw) Tab"
on page 110)
In manual mode, beginning and end of the Washout phase must be manually determined.
After a successful test, the message Good effort will be displayed.
Fig. 3-26 FRC Test
EasyOne Pro™ / EasyOne Pro™ LAB 65
Performing a Test
3.9 Ending the Test
At the end of the test, push the spirette™ out of the sensor from below.
Dispose of it and do not reuse. Also, replace the barriette™ after each
patient. Refer to section "Hygiene, Cleaning, Maintenance, Disposal" on
page 89 for sensor cleaning instructions.
Warning
Risk of Infection—
spirette™ and DLCO barriette™/FRC barriette™ are
intended for single patient use. Use new ones for each
new patient.
After tests on patients with an infection of the respiratory
tract or patients with a suspected infection of the
respiratory tract, it is recommended to clean all parts
(outside of the sensor) that were touched during the test,
before testing a new patient (see "Hygiene, Cleaning,
Maintenance, Disposal" on page 89).
3.10 Retrieving/Printing Stored Tests
EasyOne Pro™ saves all tests. Old measurements can be called up at any
time to
perform a new test with the same patient
add a spirometry trial
add a post-medication test
review or print the results.
Note
It is only possible to add a trial to a previous test that was
performed on the same day (see "Adding a Spirometry Trial"
on page 50).
Select the patient (see "Selecting/Adding a Patient" on page 40).
66 EasyOne Pro™ / EasyOne Pro™ LAB
Performing a Test
Click the History button (Fig. 3-27).
Fig. 3-27 Retrieving/printing stored tests
A window listing all tests stored for this patient will appear.
Fig. 3-28 Test list
The displayed tests can be sorted by
test protocol (Base, Pre, Post)
test type (FVC, SVC, MVV)
test date
comment.
To do so, click on the appropriate title in the column headers.
Highlight the test to view.
Click View Test to view the test, Print Preview to view the test before
printing it, Print to print the test, or Trend to view the trend display (see
"Trend View" on page 69). Click Patients to display the patient list and
click New Test to display the test selection menu.
EasyOne Pro™ / EasyOne Pro™ LAB 67
Performing a Test
a
b
c d
a Window showing the currently selected
test report
b Click to open the layout selection menu
c Click to print the displayed report
d Click to access a submenu with options
for zooming, exporting, viewing,
printer selection and additional print
functions
Note
Alternative: Double-click on a test to display it.
Examinations for which a Post-test exist, are identified by a
small arrow symbol
.
When you select Print Preview, you will see the print preview of the test:
select b to display the test report menu (report layout)
select c to print the test (select the printer)
select d to change the display scale.
Fig. 3-29 Print preview of the test
68 EasyOne Pro™ / EasyOne Pro™ LAB
3.11 Trend View
a bc d
a Option buttons for selection of the view
b Displayed parameter labels
c Click to select a parameter
d Icon to initiate the trend printout
The trend views allow you to observe the measured parameter values over a
period of time. You can choose between two different views:
One of the views simultaneously presents up to four parameters,
allowing them to be compared. Each parameter has its own vertical
axis and scale.
In the second view, a single parameter can be compared with the
predicted normals.
Performing a Test
Fig. 3-30 Trend view of multiple parameters
EasyOne Pro™ / EasyOne Pro™ LAB 69
Performing a Test
Fig. 3-31 Trend view of a single parameter and its predicted normals
70 EasyOne Pro™ / EasyOne Pro™ LAB
Editing Patient Data
4 Editing Patient Data
On the initial screen, click Select Patient.
Select the patient.
Click Edit Patient.
The patient data window will appear.
Fig. 4-1 Patient data window
Change or add data.
Click Update existing tests to close the window (for example, if the
entered patient data were incorrect and the tests need to be
recalculated) or close the window with OK if you want to apply the edited
data to future tests only.
EasyOne Pro™ / EasyOne Pro™ LAB 71
Quality Messages and Quality Grades
5 Quality Messages and Quality Grades
5.1 FVC/FVL Quality Messages and Quality Grades
Some Basic Facts
End-of-Test criteria, quality criteria and quality grading are based upon the
following published standards:
[1] Standardization of Spirometry. 1994 Update, Am J Respir Crit Care
Med, Vol 152.
[2] Office Spirometry for Lung Health Assessment in Adults: A
Consensus Statement from the National Lung Health Education
Program. Respir Care, 2000, Vol 45, No 5.
[3] ATS/ERS Task Force: Standardization of Lung Function Testing. Eur
Respir J 2005; 26.
[4] An Official American Thoracic Society/European Respiratory Society
Statement: Pulmonary Function Testing in Preschool Children. Am J
Respir Crit Care Med, 2007, Vol 175.
The quality grading is based on [2], [3] and [4].
Additional remarks
The main articles [2] and [3] do not numerically define the minimum
expiratory peak flow time (PEFT) that is required for an acceptable test. In
this case, 160 ms is used.
The end-of-test criteria for FVC tests are as follows: A test ends when the
volume change during the last 2 seconds is <45 ml, or an inspiratory
volume >150 ml is detected. This end-of-test criterion slightly differs from
the published criterion in [3] which is 25 ml in the last second. Reason:
When the 25 ml in 1 second criterion is applied to the 24 waveforms also
defined in [1] and [2], several curves will end too early, and these tests
might fail. We therefore decided to slightly change the criterion to 45 ml
in 2 seconds.
In the following tables the quality messages and the quality criteria are
detailed.
The end-of-test criterion for an FVC test is as follows: A test ends when the
volume change during the last 2 seconds is <45 ml, or an inspiratory volume
>150 ml is detected. When this end-of-test criterion is met, the following
quality messages are checked:
72 EasyOne Pro™ / EasyOne Pro™ LAB
Quality Messages and Quality Grades
FVC/FVL Quality Messages
Message Criterion
Don’t hesitate … Back-extrapolated volume greater
than 150 ml or 5% of FVC
whichever is greater (for age
80 ml or 12.5% of FVC whichever
is greater)
Blast out faster … Time until peak flow greater than
Blow out longer … Expiration time less than 2
Test Abr upt En d! FVC Test onl y: Expi ra tion tim e less
Good effort, do next …Test meets above criteria. Good trial. Only one to two more
Do not start too
early!
160 ms
seconds OR volume in the last 0.5
seconds of the expiration larger
than 100 ml
than 2 seconds OR volume during
last 0.5 seconds >40 ml when
expiration time is <6 seconds OR
volume during last second >25 ml
when end-of-test was initiated by
an inspiration.
The time to peak flow (PEFT) is
less than 30 ms or flow detected
before sensor was initialized (Wait
until 'Start Maneuver …' is
displayed)
6:
Recommended action
The patient must exhale all air at
once and not exhale in short
bursts.
The patient must exhale more
explosively and as firmly and
quickly as possible.
The patient stopped exhaling too
early. The patient must exhale still
further and force as much air as
possible out of his or her lungs.
The patient stopped exhaling too
early. The patient must exhale still
further and force as much air as
possible out of his or her lungs.
good trials and the test is
complete.
Instruct the patient to wait until
the baseline setting is finished
and the device signals that the
trial can start ('Start maneuver …')
Cough detected. Try
again…
Deeper breath … FEV1 or FVC* not reproducible.
A cough has been detected (PEF or
PIF >19 l/s)
Difference with respect to best
test greater than 150 ml or 100 ml
if FVC is < 1.0L (for age
or 10% of FEV1 or FVC* whichever
is greater)
6: 100 ml
Instruct the patient to avoid
coughing during the
measurement. Repeat the test.
The test differs greatly from
previous tests. The patient can
inhale even more deeply and
exhale even more air.
EasyOne Pro™ / EasyOne Pro™ LAB 73
Quality Messages and Quality Grades
Message Criterion
No maneuver
detected!
Session Complete!
Great Job!
No parameter calculation possible Instruct the patient to perform the
QC grade A or B reached. The test is complete. An adequate
Recommended action
maneuver according to its
definition.
number of good tests is available.
*When using FEV6 instead of FVC, FEV6 is also used for the determination of
the quality message.
FVC/FVL Quality Grades
Rating Criteria
A At least 3 acceptable tests (for age
best two FEV1 and FVC values is equal to or less than 100 ml (80 ml if FVC < 1.0 l) (for
6: 80 ml or 8% of FVC whichever is greater)
age
B At least 3 acceptable tests (for age
C At least 2 acceptable tests AND the difference between the best two FEV1 and FVC
best two FEV1 and FVC values is equal to or less than 150 ml (100 ml if FVC < 1.0 l)
6: 100 ml or 10% of FVC whichever is greater)
(for age
values is equal to or less than 200 ml (150 ml if FVC < 1.0 l) (for age
15% of FVC whichever is greater)
6: 2 acceptable) AND the difference between the
6: 2 acceptable) AND the difference between the
6: 150 ml or
D (1) At least 2 acceptable trials but the results are not reproducible according to 'C'.
D (2) Only one acceptable trial
F No acceptable trial available
Quality message: "Result not reproducible" OR only one acceptable trial. Quality
message: "Only one acceptable trial".
74 EasyOne Pro™ / EasyOne Pro™ LAB
Quality Messages and Quality Grades
5.2 SVC Quality Messages and Quality Grades
The quality grading is based on [3].
SVC Quality Messages
The end-of-test criterion for an SVC test is the same as for an FVC test: A test
ends when the volume change during the last 2 seconds is 30 ml (test
time 6 s) 45 ml (test time > 6 s) or if an inspiratory volume >
detected.
When this end-of-test criterion is met, the following quality messages are
checked:
Message Criterion Recommended action
120 ml is
Deeper breath VC of the two largest, accepted
trials are not reproducible.
Difference with respect to best
test greater than 150 ml.
No Steady-Tidal
breathing detected
Maneuver
incomplete
Do not start too
early!
Good effort, do next Test meets above criteria. Good trial. Only one to two more
Session Complete!
Great Job!
All end-inspiratory volumes of the
last 3 breaths within 200 ml.
No ERV and/or no IRV could be
calculated due an incomplete
maneuver session.
Too early, flow detected. Instruct the patient to wait until
QC grade A, VC variability
and at least 3 acceptable trials
available.
150 ml
The test differs greatly from
previous tests. The patient can
inhale even more deeply and
exhale even more air.
Instruct patient to breathe quietly
and steadily.
Perform SVC test according to
ERS/ATS recommendation.
the baseline setting is finished
and the device signals that the
trial can start ('Start maneuver …')
good trials and the test is
complete.
The test is complete. An adequate
number of good tests is available.
EasyOne Pro™ / EasyOne Pro™ LAB 75
SVC Quality Grades
Rating Criteria
Quality Messages and Quality Grades
A At least 3 acceptable tests AND the difference between the best VC values is equal to
B At least 2 acceptable tests AND the difference between the best VC values is equal to
D (1) At least 2 acceptable trials but the results are not reproducible according to 'B'.
D (2) Only one acceptable trial
F No acceptable trial available
or less than 150 ml.
or less than 150 ml.
5.3 DLCO Quality Messages and Quality Grades
The quality grading is based on ATS/ERS Guidelines [3].
DLCO Quality Messages
Message
Breath Hold Time out
of Range
Maneuver not
acceptable. Breath
Hold Time is outside
the 8-12 seconds
range
Criterion
Breath-hold time outside 8 to 12
seconds
Recommended action
Exhale immediately when the
valve opens
Parameter out of
Range
Test ca nnot b e
evaluated; sensor
signals do not pass
QC check
A parameter is out of range, e.g. a
gas concentration is higher or
lower than permitted
1) Helium concentration out of
range
2) CO at zero not within 80 ppm
3) CO at DLCO test gas not
within 500 ppm
4) Alveolar CO out of range
5) Expiratory CO out of range
6) VA out of range
7) DLCO out of range
Check for leaks; make sure
concentrations of gas cylinder are
entered correctly
76 EasyOne Pro™ / EasyOne Pro™ LAB
Quality Messages and Quality Grades
Message
Low Inspiratory
Volum e
Maneuver not
acceptable.
Inspiratory volume
too low
Inspiratory Time Too
Long
Maneuver not
acceptable.
Inspiration time
exceeds the
maximum of 4
seconds
Sampling volume at
this position too
large
Difference
Preparation and
Maneuver
Test ca nnot b e
evaluated; gas
sensor signals do
not pass QC check,
possibly due to leaks
Criterion
The inspiratory volume is smaller
than 85% FVC/VC/Predicted
Inspiratory time > 4 seconds Inhale test gas faster
Sample volume not correctly
determined
Reference gas measurement and
inspiratory gas measurements do
not match within 80 ppm. This
means that most probably there is
a leak in the DLCO hose
Recommended action
Make sure to perform a full
expiration before the valve closes,
and then a full inhalation of test
gas
Reduce sample volume
Check for leaks; check gas supply
Sampling volume at
maximum position
Test ca nnot b e
evaluated; exhaled
volume too small
DLCO-Warning: High
inspiratory CO during
tidal breathing!
Breath-Num
Test ca nnot b e
evaluated; DLCO
maneuver cannot be
detected
Can happen when very small
volumes are exhaled
Collection bar is beyond rightmost
position
An increased CO level was
detected during the tidal
breathing phase.
Breath number of DLCO expiration
could not be detected
Exhale fully after the breath hold
Check the DLCO valve unit.
If the error occurs repeatedly then
please contact service.
Perform the DLCO maneuver with
full effort
EasyOne Pro™ / EasyOne Pro™ LAB 77
Quality Messages and Quality Grades
Message
CO-Calib
CO calibration could
not be performed: no
gas connected to the
system or Instrument
failure
Delay Error
Test ca nnot b e
evaluated; gas
signals do not pass
QC check, automatic
delay correction
failed
End-Insp-Exp
Test ca nnot b e
evaluated; no tidal
breathing detected
prior to DLCO
maneuver
CO-Insp Drift
Maneuver not
acceptable; no stable CO signal during
breath-hold
Criterion
CO calibration could not be
performed: Instrument failure
and/or no gas connected to the
system
Automatic time delay correction
failed
No tidal breathing has been
detected before the test
During breath-hold, CO signal
drifts up or down
Recommended action
Make sure the gas supply is
connected and open
Repeat test correctly
Repeat test correctly
Check spirette
position, check connections,
check DLCO valve unit
™ und barriette™
78 EasyOne Pro™ / EasyOne Pro™ LAB
Quality Messages and Quality Grades
DLCO Acceptability and Quality Grades
The implemented quality grades are designed to provide guidance for
determining the quality of DLCO test sessions.
Score VI [%] BHT [s]
Sample
Volume [l]
A >
B >
C >
D >
F -- - - - -
95% 9.0 - 11.0 0.5 - 1.0 <5.0% or <11.5 - 2.5 >1
90% 8.5 - 11.5 0.5 - 1.0 <7.5% or <21.0 - 3.5 >1
85% 8.0 - 12.0 0.5 - 1.0 <10% or <3<4.0 >1
80% 8.0 - 12.0 - <4<4.0 >1
DLCO Var. [ml/
min/mmHg]
Inspiratory
Time [s]
Accept.
Trials
The score with the lowest value determines the overall score. For quality
grading, all acceptable trials are taken into account.
The following parameters determine the score and quality grades:
1. VI as a percentage of VCtarget: Inspired volume as a percentage of FVC,
VC from a previous test. If none of these is available, the target value is
taken from the test itself.
2 BHT: Breath-hold time in seconds.
3 Sample Volume: Sampling volume for CO and helium measurement
(also called collection window). The sampling volume will be outside
this window only under special circumstances (e.g. for very small VCs).
4 DLCO variability as a percentage and in absolute values.
5 Inspiratory time in seconds.
6 Number of accepted trials.
In order to be acceptable, a trial must meet the following criteria:
VI >85% of VCtarget
Breath-hold time (BHT) of 8.0 to 12.0 seconds
Inspiratory time 4 seconds
Note
The quality grades are recomputed if the user manually
changes the sampling window position (repositioning of the
collection bar).
EasyOne Pro™ / EasyOne Pro™ LAB 79
Quality Messages and Quality Grades
5.4 FRC Quality Messages
Message Criterion Recommended action
FRC(MBW) Warning:
Extrapolated volume
computation failed
(set to zero)!
FRC(MBW) Warning:
Extrapolated volume
computation too
high (set to zero)!
FRC(MBW) Warning:
Inspiratory gas leak!
FRC(MBW) Warning:
In- or expiratory pressure too high!
The extrapolated volume could
not be calculated.
The extrapolated volume (i.e., the
volume that would be washed out
after cancellation of the test) is
greater than 1 liter.
Air entered from outside during
inspiration.
The end-inspiratory molar mass
deviates from the tracer gas molar
mass by more than 0.2 g/mol.
This is indicative of air drawn in
from outside during inspiration.
Pressure in sensor tube is too
high.
The pressure in the sensor tube
exceeds ±5 mbar; possible reasons are:
1) Insufficient pressure at the O2
gas port.
2) Patient's breaths are too deep;
the respiratory resistance and
thus the pressure drop increase
from about 2 l/s.
Contact service.
Do not stop too soon.
Check FRC barriette™: are valves
jammed or was the FRC barri-
ette™ not been properly inserted?
Check position of spirette™ and
of nose clip.
Ask patient to breathe calmly.
Check O2 gas supply: Is the inlet
pressure 3 bar? Only minimal
pressure variations are allowed
during the test.
Is the patient's breathing too
deep/too fast?
Ask the patient to breathe within
the limits of ±1.5 l/s.
FRC(MBW) Warning:
Side-Stream Flow out
of range!
FRC(MBW) Warning:
CO2 sensor scaling
warning!
FRC(MBW) Warning:
Tracer concentration
at test end too high!
During the test, the gas extraction
was not within the limits of 7.5
and 13 ml/s.
concentra-
2
2
sig-
Automatic scaling of the CO
nal failed.
No breath with an N
tion below 2% was measured.
Contact service.
Contact service.
Repeat test.
80 EasyOne Pro™ / EasyOne Pro™ LAB
Quality Messages and Quality Grades
Message Criterion Recommended action
FRC(MBW) Error: No
start of washout
detected!
FRC(MBW) Error:
Error in Gas Signal
Delay Correction!
FRC(MBW) Error: Not
enough breaths for
washout computation!
FRC(MBW) Error:
Error in Tracer Gas
Concentration!
FRC(MBW) Error:
Error in Alveolar
Curve Computation!
FRC(MBW) Error:
DLCO Valve Unit NOT
mounted on handle
sensor!
Multi Breath Washout not found. Perform washout procedure cor-
rectly.
An error occurred during the automatic determination of the delay
between gas signals and flow (i.e.,
the delay is not within the desired
range).
The number of breaths required
for calculation of FRC was not
reached.
The molar mass change caused by
the tracer gas does not correspond to the theoretical values.
An error occurred during calculation of the alveolar gas curve
(from the first breaths of the
washout).
Check FRC barriette™ position.
Contact service.
FRC test was stopped prematurely.
Check whether O2 is used.
Check gas connections for leaks.
Check FRC barriette™ position.
Check that the test is correctly
performed.
Check position of spirette™ and
of nose clip.
Contact service.
Mount valve unit and repeat procedure.
EasyOne Pro™ / EasyOne Pro™ LAB 81
Quality Messages and Quality Grades
a bcd
a Pre-medication test results
b Quality grade
c System interpretation
d Post-medication test results and
deviation from Pre-test results
5.5 System Interpretation
In assessing the system interpretation, it is important to consider the
quality grade b of the test. Quality grades A to C indicate a reliable result. A
quality grade of D or F indicates inadequate test quality. The result must
then be interpreted with caution (see section "Interpretation" on page 120
for details).
You can view the test result on the monitor as soon as you see message
Session Complete! after performing a test.
Fig. 5-1 Test results, system interpretation
5.6 Retrospective Test
Changing the Trial Acceptability
The trial acceptability and ranking of tests can be changed retrospectively.
This means that you can make tests unacceptable that the system judged
acceptable and vice versa. You can also change the trial ranking (rank 1, 2 or
3).
Click a (Fig. 5-2).
82 EasyOne Pro™ / EasyOne Pro™ LAB
Assessment, Entering Comments
Note
You must be logged in as a user to be able to enter a test
assessment and comments.
Quality Messages and Quality Grades
a
b
The test assessment icons b appear on the test results screen.
Fig. 5-2 Changing the trial acceptability
Follow these steps to make a test acceptable that the system judged
unacceptable:
Click the icon.
In the ensuing window, select the Acceptable check box.
Fig. 5-3 Changing the trial ranking
To assign the highest rank to a test
click the icon and
in the ensuing window, click Set Highest Ranked (Fig. 5-4).
EasyOne Pro™ / EasyOne Pro™ LAB 83
Quality Messages and Quality Grades
Note
To assign ranks 1, 2 and 3, please start with rank 3, etc.
Fig. 5-4 Changing the trial ranking
Entering comments
Click in the comment area or click .
Enter a user ID, followed by the comment.
Close the window with Save.
The text will be shown in the comment window, including the user ID and
the date.
Fig. 5-5 Entering comments
84 EasyOne Pro™ / EasyOne Pro™ LAB
Quality Messages and Quality Grades
5.7 Definition of Important Parameters
FVC Forced Vital Capacity
(expiratory)
FIVC Forced Vital Capacity
(inspiratory)
FEV1 Forced Expiratory Volume
(1 s)
FEV6 Forced Expiratory Volume
(6 s)
forced expiratory vital
capacity
forced inspiratory vital
capacity
forced expiratory volume
after 1 second
forced expiratory volume
after 6 seconds
FEV1/FVC ratio of FEV1 to FVC
FEV1/VC
max
ratio of FEV1 to VC
max
FEV1/FEV6 ratio of FEV1 to FEV6
FEF 50
(MEF 50)
FEF 25-75 Mid-Expiratory Flow (25%-
Mid-Expiratory Flow (50%) flow at 50% of expiratory
vital capacity
flow at 25% to 75% of
75%)
expiratory vital capacity
PEF Peak Expiratory Flow peak expiratory flow
PIF Peak Inspiratory Flow peak inspiratory flow
VT Tidal Volume Tidal volume at rest
ERV Expiratory Reserve Volume expiratory reserve volume
IRV Inspiratory Reserve
inspiratory reserve volume
Vol ume
VCmax Maximum Vital Capacity maximum vital capacity of
an SVC, FVC, FVL or DLCO
test
VCex Expiratory Vital Capacity expiratory vital capacity of
a slow spirometric test
VI Inspiratory Vital Capacity inspiratory vital capacity of
a slow spirometric test
IC Inspiratory Capacity inspiratory capacity
(VT + IRV)
EasyOne Pro™ / EasyOne Pro™ LAB 85
Quality Messages and Quality Grades
MVV Maximum Voluntary
Ventilation
maximum ventilation
volume per minute
LLN Lower Limit of Normal lower limit of normal
Lung Age lung age, see section
"Predicted Values" on
page 123 [8]
DLCO CO diffusing capacity
(ml/min/mmHg)
TLCO CO diffusing capacity
(mmol/min/kPa)
DLadj Diffusing capacity
adjusted (Hb, PaO
, COhb,
2
CO diffusing capacity
(ml/min/mmHg)
CO diffusing capacity
(mmol/min/kPa)
adjusted diffusing
capacity
altitude)
VA Alveolar volume (BTPS) alveolar volume (BTPS)
DLCO/VA Krogh Factor Krogh factor
TLC Total Lung Capacity total lung capacity
Note
The parameter names used are those standardized by ATS
and ERS. See literature references [14] and [11] ("Literature"
on page 165).
86 EasyOne Pro™ / EasyOne Pro™ LAB
FRC
Quality Messages and Quality Grades
FRC
MB
Functional Residual Capacity
LCI Lung Clearance Index (equals CEV
divided by FRC at 1/40th of initial
tracer concentration (2% N2), see
"Literature" on page 165 [16])
CEV Cumulative Expired Volume
VT Tidal Volume
VT/kg Tidal Volume/kg
f Breathing Frequency
M0, MR1,
MR2
Moment Value and Moment Ratios
1 and 2 from nitrogen washout
moment analysis. Clinical use of
these parameters is limited since
the available reference data is
based on a small number of patients (see "Literature" on page 165
[17] to [21]); for a detailed description, please refer to chapter "Easy-
One Pro LAB Washout Moment
Analysis" on page 164 in the
Appendix of this manual.
EasyOne Pro™ / EasyOne Pro™ LAB 87
Switching the Device Off
6Switching the Device Off
Caution
Loss of Data—Be sure to correctly terminate the program
before switching EasyOne Pro™ off with the mains power
switch on the back.
Close the main valve of the gas cylinder.
Close the main valve of the O2 gas cylinder or disconnect the wall outlet.
Note
When using the wall outlet, please observe the hospital's inhouse instructions and requirements.
Quit the program with .
Fig. 6-1
Switch off EasyOne Pro™ with OK, or release gas pressure with Release
pressure, if you need to replace a gas cylinder. Then click OK to confirm
the message. EasyOne Pro™ will automatically switch off.
Caution
The device will switch off, but it remains connected to line
power. Only with the mains power switch at the back will
EasyOne Pro™ be disconnected from line power.
88 EasyOne Pro™ / EasyOne Pro™ LAB
Hygiene, Cleaning, Maintenance, Disposal
7 Hygiene, Cleaning, Maintenance, Disposal
Hygiene
Caution
Risk of Infection—
Users with open wounds or contagious diseases on their
hands must wear gloves.
Wash your hands after each patient to protect yourself
and to prevent cross contamination.
The spirette™ and the barriette™ must be properly
disposed of immediately after use.
Cleaning
Warning
Shock Hazard—Disconnect the device from the power line
before cleaning.
Wipe the device surface down with a cloth moistened with alcohol (70%
max.), avoiding the display, the rear panel and the temperature and
humidity sensor. Do not let liquid enter the device.
To clean the rear panel and the temperature and humidity sensor, simply
wipe them off with a dry cloth.
The display is also cleaned with a soft, dry cloth. In case of major
contamination, you can use a cloth moistened with alcohol (50% max.).
Wipe the sensor, the valve unit, the gas supply tube and the power cord
down with a cloth moistened with alcohol (70% max.). Do not let liquid
enter the parts. Replace the gas supply tube each year.
The connecting tube to the gas cylinder and the touch stylus can be
cleaned with a cloth moistened with alcohol (70% max.).
The one-way valve can be rubbed down with a cloth moistened with
alcohol (50% max.). Clean only the side facing the
barriette™
and the
housing. The one-way valve must be replaced each year.
EasyOne Pro™ / EasyOne Pro™ LAB 89
Maintenance
Hygiene, Cleaning, Maintenance, Disposal
Before each use
Before each use, visually inspect the device, the cables, the tubing and the
sensor for signs of mechanical damage. Particularly inspect the gas
cylinder(s) and fittings.
If you detect damage or impaired functions that may adversely affect the
safety of the patient or user, do not use EasyOne Pro™ before it has been
repaired.
Once a year
The following parts must be replaced once a year (see "Start-up and Initial
Preparation" on page 19):
the gas supply tube
the one-way valve.
Every three years
The filter pack at the back of the device must be replaced every three
years. It consists of the air inlet with filter and a Nafion tube to dry the
sampled gas. Open the screw on the right to replace the filter pack
(Fig. 7-1).
Fig. 7-1 Screw to replace the filter pack
90 EasyOne Pro™ / EasyOne Pro™ LAB
Hygiene, Cleaning, Maintenance, Disposal
Data Backup on Memory Card
Each time the device shuts down, the patient and configuration data are
saved to a memory card (Flash card) (h, Fig. 2-2). In case of equipment
failure, the memory card can be inserted into another device and you can
continue working with the same patient database and equipment
configuration.
Follow these steps to exchange the memory card:
Quit the program with and switch off EasyOne Pro™ with OK
(see "Switching the Device Off" on page 88).
Open the two screws and take off the cover.
Grasp the tab of the memory card and remove the card from device.
Insert the memory card into the backup device.
When the backup device starts up, confirm loading the data from the
memory card.
Fig. 7-2 Screws for removing the cover
Data Backup on External Media
To prevent loss of data, we recommend to backup the data on a regular
basis, using the Export function
On the initial screen, select Utilities -> Advanced and enter the password
(EOPTM or 8005).
Choose Export and select the files for the backup.
Click Export to backup the data.
EasyOne Pro™ / EasyOne Pro™ LAB 91
Software Update
The files necessary for a software update are made available by ndd. For a
detailed description of the installation procedure, please go to www.ndd.ch,
Application Note “Update EasyOne Pro Firmware” or “Update EasyOne ProLAB Firmware”.
These are the steps of the installation procedure:
1. Data backup
Save the patient data to a USB flash drive (memory stick).
2. Preparation
Download the most recent revision of the EasyOne Pro software from
3. Software Update
Connect the USB flash drive to EasyOne Pro™.
Click Utilities -> Advanced.
Enter the password (EOPTM or 8005).
Click Software Update and double-click the update file on the USB
Follow the on-screen instructions.
Hygiene, Cleaning, Maintenance, Disposal
Note
Before installing the update, close Adobe Reader or the
Operator's Manual.
the ndd website:
http://www.ndd.ch/Downloads/Software.aspx and copy the data to a
USB flash drive (memory stick).
flash drive.
4. Check settings
Check whether the sensor symbol is displayed.
5. Check function
Perform a calibration test (Utilities -> Calibration test).
Calibrating the Touch Screen
When you notice that you are no longer able to activate system functions by
touching the keys or fields on the display or that the positions have moved,
it is necessary to calibrate the touch screen:
On the initial screen, select Utilities -> Advanced and enter the password
(EOPTM or 8005).
Select Touch calibration.
In the ensuing window, select Configure -> Standard Configuration and
follow the displayed prompts.
92 EasyOne Pro™ / EasyOne Pro™ LAB
Hygiene, Cleaning, Maintenance, Disposal
Caution: When you miss the correct spots, the window will disappear. In
this case you have to restart the device and the calibration procedure.
Technical Inspections
For safety, the device requires regular maintenance. To ensure functional and
operational safety of the device, Technical Inspections should be carried out
on an annual basis.
These checks should be performed by persons with adequate training and
experience.
The inspections include the following checks:
Visually inspect the device and the accessories for signs of
mechanical damage that may impair the device functions.
Check that the device safety labelling is legible.
Run a functional test.
Check measuring accuracy (see following section).
Check Measuring Accuracy
Calibration Check with Syringe
Note
As an alternative, the calibration can be checked with a test
subject (see "Calibration Check with Test Subject" on
page 96).
The EasyOne Pro™ calibration can be checked with a syringe using the
calibration check function. The American Thoracic Society (ATS)
recommends that the spirometer calibration be checked on a regular basis.
Owing to the ultrasound technology used in the flow sensor, the device
requires no calibration, even if used frequently. To comply with the
recommendations, you can check the calibration as follows:
You need the ndd calibration adapter and a calibration syringe (order
number 2030-2).
Using the calibration adapter, connect the sensor to the syringe as
shown below. Ensure that the piston is fully inserted and at the stop
position.
In the Utilities menu, click Calibration Check, then select Syringe
Calibration Check.
On the test screen, click Start.
Wait until the baseline has been set.
Now execute one full inspiratory pump stroke followed by one full
expiratory pump stroke at moderate speed.
EasyOne Pro™ / EasyOne Pro™ LAB 93
Hygiene, Cleaning, Maintenance, Disposal
Three full trials are required for the Single Flow calibration check,
whereas three tests comprising three trials each with different flow rates
are required for the Multiflow calibration check.
After you perform the maneuver, you will see the text Accuracy confirmed
and, beneath it, the percentage deviation and the average flow velocity of
the pump stroke.
You can repeat the test, print the result or quit the program. The calibration
test remains stored and can also be viewed or printed out later.
If you do not reach ±3% accuracy, please follow the troubleshooting
instructions in chapter "Troubleshooting Tips" on page 116. Should you not
be able to remedy the defect by following these instructions either, please
consult ndd or one of their representatives.
Fig. 7-3 Calibration syringe
DLCO Calibration Check
The American Thoracic Society (ATS) recommends checking DLCO
calibration on a weekly basis or whenever irregularities are suspected. DLCO
calibration can be checked with a DLCO simulator (see following section) or
with a test subject (see "Calibration Check with Test Subject" on page 96).
In addition, the ATS/ERS guidelines (Literature [11], page 166) describe a
third method for checking DLCO calibration for which a 3-L syringe is used.
94 EasyOne Pro™ / EasyOne Pro™ LAB
Hygiene, Cleaning, Maintenance, Disposal
Calibration Check with DLCO Simulator
In the Utilities menu, click Calibration check, then select DLCO simulator.
The test procedure is the same as in a human test ("CO Diffusing Capacity
(DLCO)" on page 59). For correct handling of the DLCO simulator, please
read the manual of the simulator manufacturer.
Note
We strongly recommend using only DLCO simulators
manufactured by Hans Rudolph (DLCO Simulator, 5560
Series).
Also refer to the DLCO simulator operator manual or to the
training clip at www.ndd.ch.
As an alternative to checking calibration with a DLCO
simulator, the calibration can be checked with a test subject
(see "Calibration Check with Test Subject" on page 96).
Make sure the gas concentrations of the test gas AND the
Simulator Test Gas are entered correctly as shown in Fig.
8-13.
FRC Calibration Check
The American Thoracic Society (ATS) recommends that testing of biological
controls should be performed at least monthly.
For that purpose use a biological subject and the standard trending
functionality.
EasyOne Pro™ / EasyOne Pro™ LAB 95
Hygiene, Cleaning, Maintenance, Disposal
aehd f gb c
a Sensor selection
b Parameter value tabs
c Deselect tests (remove check mark)
d Click to conduct a new test
e Click to select the BioCal Subject
f Click to select a parameter
g Click to display the graphic trends
h Click to add a new BioCal Subject
Calibration Check with Test Subject
Some Basic Facts
Instead of a syringe a Biological Standard subject with known spirometry
values (BioCal Subject) performs a series of spirometry tests or DLCO tests.
These tests are observed and statistically controlled, if they are within an
expected range.
The data is collected on individual healthy, non-smoking BioCal Subjects
(e.g. physician, respiratory therapist, …).
Note
Also refer to www.ndd.ch. Application Note "DLCO BioCalcheck EasyOne Pro".
Fig. 7-4 BioCal Check main screen
96 EasyOne Pro™ / EasyOne Pro™ LAB
Hygiene, Cleaning, Maintenance, Disposal
Selecting a Test Subject and Performing the Calibration Check
Start the program.
Select the Utilities menu.
Open the Calibration Test menu and select Biological Calibration
Check.
The Biological Calibration Check menu (BioCal-Check main screen) is open.
Select the device according to its serial number a (check label on
sensor).
Select the BioCal Test Subject e. If the subject is not in the list, press Add
New BioCal Subject h and select the subject or add a new one.
Recommendation: Set the Patient ID to "Bio-1", "Bio-2", …
Afterwards return to the BioCal-Check main screen.
Click Add New Test d.
Perform the test (test selection: FVC, FVL, DLCO, Test-End, … according to
configuration settings)
Recommendation: Try to blow a QC grade "A" test.
Recommendation: Perform only one BioCal-Check test a day.
Press Finish Test.
To show the graphic trend, click the Graph button g.
To select another review parameter, change the selection in Displayed
Parameter Selection f.
If you selected a spirometry parameter, the spirometry BioCal quality
grades will be displayed. If you selected a DLCO parameter, the DLCO
BioCal quality grades will be displayed.
The parameter values are divided into two tab sheets b: Baseline Values
(used to calculate warning levels) and Control Values (controlled values for
BioCal-Check QC grade calculation).
To deselect a Test (Baseline and Control Values) remove the check mark c of
the corresponding test. A deselected test is not used for calculations any
more. This means also that by deselecting a baseline value, the first control
value is moved to the baseline values, because a minimum number (20) of
baseline tests is required for a valid analysis.
EasyOne Pro™ / EasyOne Pro™ LAB 97
Hygiene, Cleaning, Maintenance, Disposal
Detailed Description
FEV1, FVC and FEV6 are the spirometry parameters used for BioCal-Check
quality control. The software will establish a baseline mean value (precision
range) for each BioCal Subject and sensor from trials repeated daily for 20
days. This baseline will then be used to trend all subsequent BioCal-Check
sessions for the BioCal Subject and sensor. Immediate quality feedback will
be provided by the software in accordance with the BioCal-Check QC grades
alerting the user of quality warning conditions for the parameters collected.
The BioCal-Check data will be plotted against time. The BioCal-Check
reference lines will be mean (precision range), upper limit and lower limit.
The upper and lower limits are +/- 2 SD (Standard Deviation).
Specifications of the BioCal-Check QC Grades
For each parameter (FEV1, FVC, FEV6, DLCO, VI, VA) an individual BioCalCheck QC grade is calculated. Additionally the lowest grade of all
parameters is reported.
Bio-QC
Grade
BA --
BB 1 value outside ±2SD -
BC 1 value outside ±3SD -
BD
BF < 20 baseline values -
Limitation Additional Limitation
>= 4 values outside ±1SD only consecutive values on
same side of mean
>= 2 values outside ±2SD only consecutive values on
same side of mean
> 1 value outside ±3SD -
>= 10 values, consecutive
values on same side of
mean
-
Disposal
The product described in this operator manual must not be disposed as
unsorted municipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
98 EasyOne Pro™ / EasyOne Pro™ LAB
8 System Settings
System Settings Menu
The system settings menu is displayed with Utilities on the initial screen.
The menu offers the following option keys:
Configuration (general settings)
Check Calibration (measuring accuracy check, see "Check Measuring
Accuracy" on page 93)
Advanced (password-protected (EOPTM or 8005): installation of
software updates, data export, touch screen calibration).
Fig. 8-1 System settings menu
Configuration
These are the tabs of the configuration menu:
General
Test
Device
Report
Printer
EMR
Environment
System Settings
Fig. 8-2 Configuration menu, General tab
EasyOne Pro™ / EasyOne Pro™ LAB 99
System Settings
a bc
a Fields for entry of the hospital/practice
name
b Click to display an illustration (logo)
c Click to display information about the
software program
General Tab
These are the tabs of the General tab:
Header
Storage
System Settings
Administrator
User Handling
Header Tab
On this tab
you enter the hospital/practice name (will appear on the initial screen
and all printed reports) a
you can add and remove an illustration (e.g. a logo, maximum size of
the bitmap: 260x80 pixels) b
you open a window with information about the software program c.
Fig. 8-3 Header tab
100 EasyOne Pro™ / EasyOne Pro™ LAB
Loading...