NDD Easy On PC Spirometer User Manual - V03b

Easy on-PC
Operator's Manual
Version V03b
Note
The information in this manual applies to software version
V1.5.x.x only. 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, Zurich, Switzerland. All rights
reserved.
No part of this manual may be reproduced without written
permission from ndd.
ndd, the ndd logo and spirette are trademarks owned
by ndd Medizintechnik AG.
ndd USA
Medizintechnik AG ndd Medical Technologies
Technoparkstrasse 1 2 Dundee Park
CH-8005 Zrich, Switzerland Andover, MA 01810
Tel: +41(44) 445 2530 Tel: 1 978 470 0923
Fax: +41(44) 445 2531 Fax: 1 978 470 0924
www.ndd.ch www.nddmed.com
2 Easy on-PC
Contents
1 Introduction 5
1.1 CE Marking Information 5
1.2 Licence Terms 5
1.3 Revision History 6
1.4 Manual Purpose 6
1.5 Intended Audience 6
1.6 Styles 6
1.7 Safety Information 7
1.8 Intended Use 12
1.9 Description of the Medical Electrical Device 13
1.10 Easy on-PC Sensor Design and Operation 13
1.11 System Requirements 14
2 Start-up and Preparation 15

2.1 Software Installation 15
2.2 Connecting the Flow Sensor 21
2.3 Preparing the Flow Sensor 24
2.4 Starting the Software Program 25
3 Performing a Test 26
3.1 Selecting/Admitting a Patient 26
3.2 Selecting a Test 31
3.3 Forced Vital Capacity (FVC/FVL) 32
3.4 Vital Capacity (SVC) 42
3.5 Maximum Voluntary Ventilation (MVV) 45
3.6 Bronchial Provocation 47
3.7 Quick Test 53
3.8 Ending the Test 53
3.9 Retrieving/Printing Stored Tests 54
3.10 Trend View 57
3.11 Definition of Important Parameters 59
3.12 Editing Patient Daa 61
3.13 Quality Messages / Grades (Details) 62
3.14 System Interpretation 67
3.15 Retrospective Test Assessment, Entering Comments 67
4 Hygiene, Cleaning, Maintenance, Disposal 70
5 System Settings 76
6 Troubleshooting Tips 92
Easy on-PC 3
Contents
7 Specifications 93
8 Technical Description 95
9 Order Information 97
10 Appendix 98
10.1 Interpretation 98
10.2 Predicted Values 102
10.3 GDT Interface 103
10.4 Report Designer 109
10.5 Electromagnetic Compatibility (EMC) 113
10.6 Quick Reference Guide to the Screen Displays 118
10.7 Literature 132
4 Easy on-PC
Introduction
1 Introduction
1.1 CE Marking Information

The product Easy on-PC 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 Safety" as well as
the electromagnetic immunity requirements of standard EN 60601-1-2
"Electromagnetic Compatibility Medical Electrical Equipment".
The radio-interference emitted by the flow sensor 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 country of manufacture appears on the device label.
1.2 Licence Terms

By installing the software, you accept the following terms. If you do not
accept these terms, please return the product, including all documentation
and hardware supplied with the product, to your supplier in return for the
reimbursement of the purchase price.
The subject of the contract is the grant of a licence to use the software and
the product documentation. ndd grants you a personal, non-exclusive and
non-transferable right of use. The software and the accompanying
documentation are protected by copyright. The licensee shall comply with
the provisions of copyright law.
Ownership and all other rights to the software are retained by ndd. You may
not transfer the software by network or data channel to another computer.
Easy on-PC 5
Introduction
The software and the accompanying product documentation may not be

altered or copied or, in an altered version, combined with other software
and made accessible to third parties. The licensee shall be liable for all
damage incurred by the licensor as the result of a violation of copyright in
breach of these terms of contract.
1.3 Revision History

Edition Date Comment
Version V01 2008-07-22 Initial Release
Version V01 Rev. A 2008-09-18 Revised Version
Version V01 Rev. B 2010-03-04 Revised Version
Version V02 2010-04-06 Revised Version
Version V03 2012-11-26 Revised Version
Version V03b 2012-12-06 Revised Version
1.4 Manual Purpose

This manual contains the instructions necessary to employ the product
safely and in accordance with its function and intended use.
1.5 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.
1.6 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, Easy on-PC.
6 Easy on-PC
Introduction
1.7 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.
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 non-
ndd 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 electromedical equipment standard IEC 60601-1-1.
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 Zurich,
Switzerland
Easy on-PC 7
Introduction
Definitions
In this manual the safety information is classified as follows:
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.
Safety Information
Danger
Explosion HazardThe flow sensor is not designed for use in
areas of medical locations where an explosion hazard may
occur. 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.
Warning
Shock Hazard
If the flow sensor is connected to a PC, this PC must meet
the requirements outlined in the Technical Description
chapter.
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
8 Easy on-PC
Introduction
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.
Before using the device, the operator must ascertain that
it is in correct working order and operating condition. The
cables, in particular, must be checked for signs of
damage. Damaged cables and connectors must be
replaced immediately, before use.
Liquids must not be allowed to enter the flow sensor or
the PC. Devices into which liquids have entered must
immediately be cleaned and checked by a service
technician, before they can be reused.
Warning
Patient HazardThe operator must be trained in the use of
the device.
Patient HazardBefore performing any tests on patients,
refer to the ATS/ERS Taskforce recommendations (literature
[11] ("Literature" on page 132).
Patient HazardUser-configured printouts bear the label
"Custom Report". The user is entirely responsible for the
design, content and use of the printouts.
Risk of InfectionFollow 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.
Easy on-PC 9
Introduction
Risk of InfectionProper use of the spirette provides a

reliable infection barrier. The use of other accessories is not
permitted.
Cross Contamination Between PatientsThe spirette is
intended for single patient use. Use a new one for each
patient to prevent cross contamination between patients.
Suffocation HazardDispose of the packaging material,
observing the applicable waste-control regulations. Keep the
packaging material out of children's reach.
Danger
Patient hazard Observe the following point when
performing bronchial provocation tests:
Bronchial provocation tests can be dangerous for
patients! A primary condition for safe provocation test
procedures is a trained and experienced physician.
Above all, these physicians must be familiar with
appropriate precautions and guidelines, warnings,
procedures, contraindications, when to stop further
testing, etc. as defined in the medication documentation
and in the standards.
Observe the contraindications for the medication used,
such as
- general clinical instability of the patient
- severely reduced lung function
- treatment with beta blockers
- hyperresponsiveness
- pregnancy.
A physician or specially trained staff must be present
while bronchial provocation tests are being performed.
The patient should never be left unattended during the
tests.
The following should be available throughout provocation
tests:
- a medical specialist capable of treating acute
bronchospams
- appropriate medication as well as resuscitation
equipment (defibrillator, cardiac pacemaker)
Refer to the relevant literature for creating safe protocols
for bronchial provocation tests. Examples are: Sterk PJ,
Fabbri LM, Quanjer PhH, et al. Airway responsiveness.
Standardized challenge testing with pharmacological,
10 Easy on-PC
Introduction
physical and sensitizing stimuli in adults. Report Working

Party Standardization of Lung Function Tests. European
Community for Steel and Coal. Official position of the
European Respiratory Society. Eur Respir J 1993; 6:
Suppl.16, 5383).
Caution
U.S. Federal law restricts this device to sale by or on the
order of a physician.
Easy on-PC 11
Introduction
Equipment Symbols
Observe to the information given in the Operator Manual.
Single-patient use
CE marked per the Medical Device Directive 93/42/EEC of

0120 the European Union.
The number found under this symbol is the date of

manufacture in the YYYY-MM format.
Manufacturer
Type BF applied part
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!
1.8 Intended Use

The software program Easy on-PC in conjunction with the flow sensor is
designed for spirometric measurements in adults and children over the age
of 4. The Easy on-PC system is used by general practitioners, specialists, in
occupational medicine and in hospitals; it may also be used in frontline
applications (pharmacies, screening places, first aid centers). Easy on-PC is
used in combination with the spirette respiratory tube to conduct slow
and forced spirometric maneuvers and MVV tests. The Easy on-PC software
contains data management functions such as displaying, reporting and
exporting of test data.
12 Easy on-PC
Introduction
1.9 Description of the Medical Electrical Device

The Easy on-PC software is installed on a PC or laptop computer to which
the flow sensor is connected by means of a USB cable.
The PC or laptop computer which is not part of the equipment supplied by
ndd Medizintechnik AG is thus considered a requisite accessory necessary
for the intended use of the device. The requirements for the PC and laptop
computer as well as for other peripheral devices such as the monitor and
the printer are specified in chapter "Technical Description" on page 95.
The applied part comprises the handle and the spiretteTM. The connection
cable is not included.
Fig. 1-1 Medical electrical device
1.10 Easy on-PC 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.
Easy on-PC 13
Introduction
integrated mouthpiece ultrasound sensor 2 ultrasound sensor 1
Fig. 1-2 Flow sensor
1.11 System Requirements
minimum requirements
operating system Windows 7, Windows 8, 1), Windows

XP SP3, Windows Vista (32 bit and
64 bit)
1)Windows 8: EasyOne-line (Screen-
Connector) and units with serial numbers

<80000 are not currently supported.
Web browser Internet Explorer 6 or later
processor Intel -/Pentium processor or

compatible, 1 GHz
monitor resolution 1024 x 600
hard drive memory installation/system: 1 GB

data memory 4 GB
RAM 512 MB
Beyond the minimum requirements, a larger RAM of >1 GB and a larger

monitor with a resolution of 1280 x 960, for example, would be
recommended.
14 Easy on-PC
Start-up and Preparation
Note
The software supports only 100% DPI (if a value different
than 100% is selected, information may not be displayed
completely.
Use ClearType to enhance screen fonts (for Windows XP, refer
to http://support.microsoft.com/kb/306527/en-us; for
Windows Vista or newer operating systems, ClearType is the
default setting).
2 Start-up and Preparation
2.1 Software Installation

Note
Install the software on the PC before connecting the flow
sensor.
You will require Administrator privileges to install the
software on the PC.
The installation dialogs are available in English only.
Exit all programs and insert the Easy on-PC CD in the CD ROM drive. As a
rule, the installation routine starts automatically within 30 seconds of
inserting the CD. If the installation routine does not start automatically,
go to the CD-ROM directory and start the EasyWareProStarter.exe
program.
Fig. 2-1
Easy on-PC 15
Installation with Windows 7

(For installation in a Windows XP environment, please refer to "Installation with Windows XP"
on page 20 )
Fig. 2-2
Click Next.
Fig. 2-3
16 Easy on-PC
Confirm with I Agree.
Fig. 2-4
Click Next >.
Fig. 2-5
Easy on-PC 17
Option: Installing .NET Framework 4 (if not already installed)
Fig. 2-6
Click Install.
Fig. 2-7
18 Easy on-PC
Confirm with Finish.
Fig. 2-8
When this dialog is displayed, select Restart Now.
Easy on-PC 19
Installation with Windows XP
System requirements: Windows XP SP3.
Before the installation, confirm the Run As... dialog to obtain Admin
privileges (Admin privileges must be confirmed before the installation
of each sub-module, i.e., the user is repeatedly asked to confirm).
Users with Admin privileges should clear the Protect my computer ..

check box.
Fig. 2-9
Install .NET Framework 4 and restart the computer if prompted to do so.
20 Easy on-PC
2.2 Connecting the Flow Sensor

For operation of the flow sensor, the corresponding driver must be installed.
Note
In most situations the CD-ROM will not be required for
installation of the driver, because the driver already exists on
the PC.
After installation of the Easy on-PC software program, connect the USB
connector of the flow sensor to a free USB port on your PC.
The message New hardware found will appear. You will also see the Found
New Hardware Wizard.
Fig. 2-10
Answer the prompt Can Windows connect to Windows Update to search

for software with No, not this time and click Next >.
.
Fig. 2-11
Easy on-PC 21
At the prompt What do you want the wizard to do? select Install the
software automatically (Recommended) and click Next >.
Fig. 2-12
After the driver has been found on the system, the following message
displays:
Fig. 2-13
22 Easy on-PC
Accept the proposed driver and click Finish.
Fig. 2-14
Click OK to save the new COM port.
Note
Please note that you will have to install the driver again, if
the flow sensor is connected to a USB port on which it was
not used before.
Easy on-PC 23
2.3 Preparing the Flow Sensor
Warning
Shock HazardIf the flow sensor is connected to a PC, this
PC must meet the requirements of IEC standard 60950-1.
Tear open the plastic bag containing the spirette and fold the bag
back, allowing you to insert the spirette into the flow sensor. Ensure
that the plastic bag protects the mouthpiece of the spirette until you
hand over the flow sensor to the patient.
This approach not only ensures perfectly hygienic conditions, it also keeps
the spiretteTM closed for the subsequent determination of the baseline.
Introduce 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.
Warning
Cross Contamination Between PatientsThe spirette is
intended for single patient use. Use a new one for each
patient to prevent cross contamination between patients.
Fig. 2-15 Inserting the spirette
24 Easy on-PC
2.4 Starting the Software Program

Click .
The initial screen is displayed.
a b c d e f g h i
Fig. 2-16 Initial screen

a Practice, office, hospital (see "General e Click to review the results from
Tab" on page 77 for details about previous tests
entering the data) f Click to view the setup screen
b Selected patient g Sensor status (sensor icon, if sensor is
c Click to select a patient or admit a new connected)
patient h Help button
d Click to perform a test i Click to quit the program
Note
Before working with the program, setup the system as
described in "System Settings" on page 76
enter the practice/office or hospital name
select the language
select the test types and parameters
Easy on-PC 25
Performing a Test
3 Performing a Test
Note
Before performing a test, you must 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 81)
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 53).
3.1 Selecting/Admitting a Patient

Click Select Patient.
26 Easy on-PC
Performing a Test
The patient list will be displayed.
a b c d e f g h i j k
Fig. 3-1 Patient list

a Selected patient patient (password-protected, EOPTM
b Bar cursor for patient selection or 8005)
c Click to admit a new patient h Help button
d Click to perform a test with the selected i Filter Last Name; by entering one or
patient more letters, you limit the number of
e Click to view the selected patient's test patients to those meeting the filter
results criteria
f Click to edit the selected patient's data j Additional parameters
g Click to delete the data of the selected k Back to main menu
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 i (Fig. 3-1).
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.
Easy on-PC 27
Performing a Test
Note
Click to view the patient data. Click again to close
the window.
Fig. 3-2 Window showing patient data
28 Easy on-PC
Performing a Test
Admitting a New Patient
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.
a b c
Fig. 3-3 Patient data window
Easy on-PC 29
Performing a Test
Fig. 3-4 Smoking History tab
Merging a Patients 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 pati-
ent's name exist. Use Drag & Drop (right mouse button) to merge data
records.
Fig. 3-5 Merging a patients data records
30 Easy on-PC
Performing a Test
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 menu
Note
If the unit selected is EasyOne (see "Device Tab"
on page 86), 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 87) for configuration
options.
Fig. 3-7 Selection screen when the selected device is EasyOne
Easy on-PC 31
Performing a Test
3.3 Forced Vital Capacity (FVC/FVL)

Click FVC/FVL.
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
a b c d e f g h i j k
Fig. 3-8 Expiratory FVC acquisition screen

a Selected test parameters g Click to show and hide the animation
b Predicted values, past test results of program
the patient h Show/hide expanded parameter list
c Flow-volume loop area i Volume-time curve area
d Start button j Test information and system
e Scaling interpretation area
f Displayed curve selection: best test, k Click to perform a new test, to view the
best test and pre test, all patient's test list, to select a new
patient and to print a test
32 Easy on-PC
Performing a Test
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.
Explain that the purpose of the test is to determine how much air a persons
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 spiretteTM into the mouth with the lips sealing around the
spiretteTM, taking care not to block its opening with the tongue or bite
down excessively on the spiretteTM
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 are new to spirometry, 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 spiretteTM respiratory tube
Easy on-PC 33
Performing a Test
Caution
Risk of InjuryPulmonary function tests require maximum
effort on the part of the patient and may lead to dizziness.
Risk of InfectionThe spiretteTM is designed for single use.
Use a fresh spiretteTM for each new patient.
Risk of InfectionIn settings where tuberculosis or other
diseases that are spread by droplet nuclei are likely to be
encountered, proper attention to environmental engineering
controls, such as ventilation, air filtration or ultraviolet
decontamination of air, should be used to prevent disease
transmission.
Risk of InfectionClean the nose clip after each patient.
Measurement
Insert the new spiretteTM in the sensor.

Attach the nose clip to the patient.
Click Start.
The device advises you to keep the spiretteTM closed until the test start
prompt is displayed. This is necessary to set the baseline correctly.
Note
ndd Medizintechnik AG recommends removing the rest of
the spirette packaging which wraps the mouthpiece and
keeps it closed only after the baseline has been set.
Block off the spiretteTM 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
When the system is set up for Manual Test Stop (see "Test
Tab" on page 81), the operator is required to end the test
(click the Test End button or press the Space bar or Enter
key).
During the test, you will see the flow-volume loop and the volume-time
curve on the monitor screen. All curves and measured values will be
displayed after the test.
34 Easy on-PC
Performing a Test
a b c a d e f g
Fig. 3-10 Acceptable FVC test

a Predicted values f Click for a retrospective test evaluation
b Test result or to expand the parameter list (see
c Quality message: Quality control result "Retrospective Test Assessment,
d Click to perform a post-test (see Entering Comments" on page 67)
"Bronchodilation (Post-Tests)" on g Area for review comments
page 39)
e Test information, system interpretation
In order to assess the patient's pulmonary function, it is necessary to obtain

an acceptable test quality. The test quality depends on the co-operation on
the part of the patient which, in turn, depends on the quality of the
physician's instructions. Easy on-PC incorporates an automatic quality
control function. This function analyzes the test quality and outputs a
message to inform you as to whether the maneuver was acceptable or not
(see "System Interpretation" on page 67). At the same time this function
allows the physician to improve patient instructions.
Easy on-PC 35
Performing a Test
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 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).
As soon as three acceptable tests have been performed, the message
Session complete appears and a quality grade from A (optimal) to F a is
displayed.
a b c
Fig. 3-11 Acquisition screen after three acceptable, expiratory FVC tests
a Quality grade c Area for review comments
b Click to perform a post-test (see
"Bronchodilation (Post-Tests)" on
page 39)
Note
If FEV6 is selected (instead of FVC), the measurement will
stop automatically after 6 seconds.
36 Easy on-PC
Performing a Test
%Pred Graph
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. Only the most
important parameters are displayed in color, all other parameters are grey.
a b c
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. Bear in mind, 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.
Fig. 3-13 Test menu
Click Add Trial or Add Post.

The acquisition screen will be displayed.
Perform the new spirometry maneuvers.
Easy on-PC 37
Performing a Test
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 you confirm them, if they are correct.
a b c d e f
Fig. 3-14 Window showing the ambient conditions

a Conversion factor e Click to recalculate the BTPS factor (if the
b Box for entry of the humidity ambient conditions were modified)
c Box for entry of the room temperature f Click to confirm and accept the values
d Box for entry of the altitude (atmospheric
pressure)
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.
The inspiratory and expiratory FVL test acquisition screen appears.
38 Easy on-PC
Performing a Test
Measurement
Prepare the patient (see "Preparations" on page 33) and explain the test
maneuvers:
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 34.
Note
The volume-time curve (Fig. 3-16) does not represent 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 spirometric
test (Pre-Test). Approximately 10 to 20 minutes after the medication (when
bronchodilator shows effect, observe information supplied with the
medication) a second spirometric test is performed. After the test the Pre
and Post results are compared. Post-tests can only be added to previous
tests on the same day.
Select the patient.
Select the test, then click Add Post to close the window.
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).
Easy on-PC 39
Performing a Test
Fig. 3-15 Detailed test results

Session complete appears and a quality grade from A (optimal) to F is
displayed (see "Quality Messages / Grades (Details)" on page 62).
Fig. 3-16 Acquisition screen after three acceptable post-tests
40 Easy on-PC
Performing a Test
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 81).
Fig. 3-17 Animation program for children, test start, successful test
Fig. 3-18 Animation program for children, test start, successful test
The Monkey animation can be viewed in full-screen mode .
Easy on-PC 41
Performing a Test
3.4 Vital Capacity (SVC)

Slow vital capacity measurements determine the vital capacity, starting
from tidal breathing. 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 84). 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 38).
After three acceptable maneuvers the message Session complete appears.
Select the patient (see "Selecting/Admitting a Patient" on page 26).
maneuvers:
breathe calmly in and out
when the start test prompt appears, take a maximum inspiration
followed by an immediate, but unhurried, exhalation.
Select the test with SVC.
The slow vital capacity acquisition screen appears.
42 Easy on-PC
Performing a Test
a b c d e f g h
Fig. 3-19 Slow vital capacity acquisition screen

a Selected test parameters Entering Comments" on page 67)
b Predicted values g Click to view additional information
c Volume-time curve area h Click to perform a new test, to view the
d Start button patient's test list, to select a new
e Test information and system patient and to print a test
interpretation area
f Click for a retrospective test evaluation
or to expand the parameter list (see
"Retrospective Test Assessment,
Easy on-PC 43
Performing a Test

Session complete appears and a quality grade from A (optimal) to F is
displayed (see "Quality Messages / Grades (Details)" on page 62).
Fig. 3-20 Acquisition screen after three acceptable SVC tests
44 Easy on-PC
Performing a Test
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 38).
maneuvers:
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 the test with MVV.
The MVV acquisition screen appears.
a b c d e f g h
Fig. 3-21 MVV acquisition screen

a Selected test parameters f Click for a retrospective test evaluation
b Predicted values or to expand the parameter list (see
c Volume-time curve area "Retrospective Test Assessment,
d Start button Entering Comments" on page 67)
e Test information and system g Click to view additional information
interpretation area h Click to perform a new test, to view the
patient's test list, to select a new
patient and to print a test
Easy on-PC 45
Performing a Test
Fig. 3-22 Acquisition screen after six acceptable MVV tests
46 Easy on-PC
Performing a Test
3.6 Bronchial Provocation
Introduction and Safety Information
Bronchial provocation tests are performed by administering increasing

doses of an airway irritant. The reaction of the respiratory system to these
substances is measured. A number of standardized substances are avail-
able as provocative agents.
Danger
Patient Hazard
Bronchial provocation tests can be dangerous for
patients! A primary condition for safe provocation test
procedures is a trained and experienced physician.
Physicians must be familiar with appropriate precautions
and guidelines, warnings, procedures, contraindications,
when to stop further testing, etc. as defined in the
medication documentation and in the standards.
Observe the contraindications for the medication used,
such as
- general clinical instability of the patient
- severely reduced lung function
- treatment with beta blockers
- hyperresponsiveness
- pregnancy.
A physician or specially trained staff must be present
while bronchial provocation tests are being performed.
The patient should never be left unattended during the
tests.
The following should be available throughout provocation
tests:
- a medical specialist capable of treating acute
bronchospams
- appropriate medication as well as resuscitation
equipment (defibrillator, cardiac pacemaker)
Refer to the relevant literature for creating safe protocols
for bronchial provocation tests. Examples are: Sterk PJ,
Fabbri LM, Quanjer PhH, et al. Airway responsiveness.
Standardized challenge testing with pharmacological,
physical and sensitizing stimuli in adults. Report Working
Party Standardization of Lung Function Tests. European
Community for Steel and Coal. Official position of the
European Respiratory Society. Eur Respir J 1993; 6:
Suppl.16, 5383).
Easy on-PC 47
Performing a Test
Performing a Test
Select a medication (Challenge Test Protocol, see "Provocation Tab" on

page 85). The following is a brief description of how to perform a
measurement with the Methacholine ATS short protocol (5 breaths).
Explain the test maneuver to your patient and attach the nose clip.
Select Provocation.
The initial screen is displayed.
a b c d e f g h i
Fig. 3-23 Initial screen for bronchial provocation tests

a Selected protocol f Baseline
b Protocol steps g Threshold line
c Current test step h Measured values in tabular form
d Start button i Zoom icon to change the scale
e Next action
The baseline is determined either at the pre-test stage or at the 0 mg/ml

level, depending on the test protocol. Three acceptable FEV1 measurements
should be available for the baseline determination (see "Forced Vital Capac-
ity (FVC/FVL)" on page 32).
Click Start to initiate the measurement.
48 Easy on-PC
Performing a Test
When three acceptable maneuvers have been performed, the message Ses-
sion complete! Great Job! appears.
b
c
d
Fig. 3-24 Screen after three acceptable expiratory FVC measurements

a Toggles between volume-time and test c Click to add an FEV1 measurement
diagramm d Click to display the protocol screen
b Current test step
Click Protocol (d, Fig. 3-24) to display the protocol screen.
a
b
d
Fig. 3-25 Protocol screen
a Current test step c Next action
b Pre-test value d Menu button
Note
If a reduced lung function is determined, the physician
needs to decide if and how to continue the test.
With Menu d, you can display a number of keys and then
return to the FVC acquisition screen with Spirometry, for
example.
Easy on-PC 49
Performing a Test
Now proceed to the next test step (c, Fig. 3-25) and confirm with Done.
The next step will be displayed and the next action indicated at c is Wait 30
seconds.
When the waiting time is over, click Done (you can abort the waiting time
at any time with Done).
The next step will be displayed and the next action is Perform repeatable
FEV1 measurements.
Click Start to initiate the FEV1 measurement.

Note
After the FEV1 measurement, you need to check whether the
measurement quality is sufficient or whether additional
trials are required.
With key a (Fig. 3-24) you can display the test diagram
(response curve) at any time during the test.
Click Protocol to display the protocol screen: the measurement and the
next step will be displayed and the next action shown in this example is
Administer 0.0625 mg/mL concentration.
50 Easy on-PC
Performing a Test
Continue executing the remaining levels. As soon as you reach the 20%
limit, the message POSITIVE TEST RESULT... will appear, the next level
(Post) and the next action Administer a bronchodilator will be
displayed.
Note
Some protocols require the administration of a
bronchodilator even for tests with a negative result.
Fig. 3-28 Protocol screen with a positive test result
Easy on-PC 51
Performing a Test
Perform the post test according to the instructions. Then the final proto-
col screen with the post-rest results will be displayed.
Note
After the test, the patient should leave the laboratory only
after the obstruction is reversed either spontaneously or
upon administration of a bronchodilator substance. The
reversal should be documented with a lung function test.
52 Easy on-PC
Performing a Test
3.7 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. 3-30 Menu
Click Quick Test and perform the test as usual.
Note
It is not possible to edit the predicted values retrospectively
once measurements have been taken.
3.8 Ending the Test

At the end of the test, push the spirette out of the sensor from below.
Dispose of and do not reuse. Refer to section "Hygiene, Cleaning,
Maintenance, Disposal" on page 70 for sensor cleaning instructions.
Warning
Risk of Infection
The spirette is for single use only and must not be
reused.
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 70).
Easy on-PC 53
Performing a Test
3.9 Retrieving/Printing Stored Tests

Easy on-PC 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
Bear in mind that 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 37).
Click the History button (Fig. 3-31).
Fig. 3-31 Retrieving/printing stored tests
54 Easy on-PC
Performing a Test
A window listing all tests stored for this patient will appear.
Fig. 3-32 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 57). Click Patients to display the patient list and
click New Test to display the test selection menu.
Note
Alternative: Double-click on a test to display it.
Examinations for which a Post-test exists, are identified by a
small arrow symbol .
When you select Print Preview, you will see the print preview of the test:
select b to choose the test
select c to print the test
select d to display the print menu.
Easy on-PC 55
Performing a Test
a b c d
Fig. 3-33 Print preview of the test

a Selected test c Click to print the test
b Click to select another test d Click to display the print menu
Fig. 3-34 Menu bar when the Print Menu button is pressed
56 Easy on-PC
Performing a Test
3.10 Trend View

The trend views allow you to observe the measured parameter values over a
longer 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.
a b c d
Fig. 3-35 Trend view of multiple parameters

a Option buttons for selection of the view c List boxes for parameter selection
b Displayed parameter labels d Icon to initiate the trend printout
Easy on-PC 57
Performing a Test
Fig. 3-36 Trend view of a single parameter and its predicted normals
58 Easy on-PC
Performing a Test
3.11 Definition of Important Parameters
FVC Forced Vital Capacity forced expiratory vital

(expiratory) capacity
FIVC Forced Vital Capacity forced inspiratory vital

(inspiratory) capacity
FEV1 Forced Expiratory Volume forced expiratory volume

(1 s) after 1 second
FEV6 Forced Expiratory Volume forced expiratory volume

(6 s) after 6 seconds
FEV1/FVC ratio of FEV1 to FVC
FEV1/VCmax ratio of FEV1 to VCmax
FEV1/FEV6 ratio of FEV1 to FEV6
FEF 75 Mid-Expiratory Flow (25%) flow at 75% of expiratory

(MEF 25) vital capacity


MEF 25-75 Mid-Expiratory Flow (25%- flow at 25% to 75% of

75%) expiratory vital capacity
PEF Peak Expiratory Flow peak expiratory flow
PIF Peak Inspiratory Flow peak inspiratory flow
FET Forced Expiratory Time duration of expiratory

phase
BEV Back Extrapolated Volume backextrapolated volume
VT Tidal Volume tidal volume at rest
ERV Expiratory Reserve Volume expiratory reserve volume
IRV Inspiratory Reserve inspiratory reserve volume

Volume
VC or VCmax Maximum Vital Capacity maximum vital capacity of

a slow spirometric test
Easy on-PC 59
Performing a Test
VCex Expiratory Vital Capacity expiratory vital capacity of

VCin Inspiratory Vital Capacity inspiratory vital capacity of

IC Inspiratory Capacity inspiratory capacity(VT +

IRV)
MVV Maximum Voluntary maximum ventilation

Ventilation volume per minute
% Diff (PRE/ percentage deviation of

POST %) the pre and post
medication values
(bronchodilation test)
LLN lower limit of normal
Lung Age lung age, see section

"Predicted Values" on
page 102 [8]
Note
The parameter names used by ndd Medizintechnik AG are
those standardized by ATS and ERS. (See literature
references [14] and[11] ("Literature" on page 132).
60 Easy on-PC
Performing a Test
3.12 Editing Patient Daa

Note
Changes to the patient data will only affect future
measurements. Stored tests will not be affected.
Click Select Patient on the initial screen.
Select the patient.
Click Edit Patient.
The patient data window will appear.
Fig. 3-37 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.
Easy on-PC 61
Performing a Test
3.13 Quality Messages / Grades (Details)
Some Basic Facts
End-of-Test criteria, quality criteria and quality grading are based upon the
published standards [1], [4], [11], [15] ("Literature" on page 132).
Quality grading is based on [4], [11], [15] ("Literature" on page 132).
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
applied in Easy on-PC software are detailed.
62 Easy on-PC
Performing a Test
FVC/FVL Quality Messages for Easy on-PC
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:
Message Criterion Recommended action

Dont hesitate Back-extrapolated volume greater The patient must exhale all air at
than 150 ml or 5% of FVC once and not exhale in short
whichever is greater (for age <= 6: bursts.
80ml or 12.5% of FVC whichever
is greater)
Blast out faster Time until peak flow greater than The patient must exhale more
160 ms explosively and as firmly and
quickly as possible.
Blow out longer Expiration time less than 2 The patient stopped exhaling too
seconds OR volume in the last early. The patient must exhale still
0.5 seconds of the expiration further and force as much air as
larger than 100 ml possible out of his or her lungs.
Test Abrupt End! FVC Test only: Expiration time less The patient stopped exhaling too
than 2 seconds OR volume during early. The patient must exhale still
last 0.5 seconds >40 ml when further and force as much air as
expiration time is <6 seconds OR possible out of his or her lungs.
volume during last second >25 ml
when end-of-test was initiated by
an inspiration.
Good effort, Test meets above criteria. Good trial. Only one to two more
do next good trials and the test is
complete.
Do not start too The time to peak flow (PEFT) is Instruct the patient to wait until
early! less than 30 ms or flow detected the baseline setting is finished
before sensor was initialized (Wait and the device signals that the
until 'Start Maneuver ' is trial can start ('Start maneuver ')
displayed)
Cough detected. A cough has been detected Instruct the patient to avoid
Try again... (PEF or PIF > 19l/s) coughing during the first second.
Repeat the test.
Easy on-PC 63
Performing a Test

Deeper breath FEV1 or FVC* not reproducible. The test differs greatly from
Difference with respect to best previous tests. The patient can
test greater than 150 ml or 100 ml inhale even more deeply and
if FVC is < 1.0L (for age <= 6: exhale even more air.
100 ml or 10% of FEV1 or FVC*
whichever is greater)
No maneuver No parameter calculation possible Instruct the patient to perform the

detected! maneuver according to its
definition.
Session complete! QC grade A or B reached. The test is complete. An adequate

Great Job! 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 for Easy on-PC
Rating Criteria
A At least 3 acceptable tests (for age <= 6: 2 acceptable) AND the difference between
the best two FEV1 and FVC values is equal to or less than 100 ml (80 ml if FVC < 1.0 L)
(for age <= 6: 80ml or 8% of FVC whichever is greater)
B At least 3 acceptable tests (for age <= 6: 2 acceptable) AND the difference between
the best two FEV1 and FVC values is equal to or less than 150 ml (100 ml if FVC
< 1.0 L) (for age <= 6: 100 ml or 10% of FVC whichever is greater)
C At least 2 acceptable tests AND the difference between the best two FEV1 and FVC
values is equal to or less than 200 ml (150 ml if FVC < 1.0 L) (for age <= 6: 150 ml or
15% of FVC whichever is greater)
D (1) At least 2 acceptable trials but the results are not reproducible according to 'C'.
Quality message: "Result not reproducible" OR only one acceptable trial. Quality
message: "Only one acceptable trial".
D (2) Only one acceptable trial
F No acceptable trial available
64 Easy on-PC
Performing a Test
SVC
The quality grading is based on [3].
SVC Quality Messages
The end-of-test criterion for an SVC 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 > 120 ml is
detected.
When this end-of-test criterion is met, the following quality messages are
checked:
Deeper breath VC of the two largest trials are not The test differs greatly from
reproducible. Difference with previous tests. The patient can
respect to best test greater than inhale even more deeply and
150 ml. exhale even more air.
No Steady-Tidal All end-inspiratory volumes of the Instruct patient to breathe quietly

breathing detected last 3 breaths within 200 ml. and steadily.
Maneuver No ERV and/or no IRV could be Perform SVC test according to

incomplete calculated due an incomplete ERS/ATS recommendation.
maneuver session.
Do not start too Too early, flow detected. Instruct the patient to wait until
early! the baseline setting is finished
and the device signals that the
trial can start ('Start maneuver ')
Good effort, do next Test meets above criteria. Good trial. Only one to two more
good trials and the test is
complete.
Session complete! QC grade A, VC variability <= The test is complete. An adequate

Great Job! 150 ml and at least 3 acceptable number of good tests is available.
trials available.
Easy on-PC 65
Performing a Test
SVC Quality Grades
Rating Criteria
A At least 3 acceptable tests AND the difference between the best VC values is equal to
or less than 150 ml.
B At least 2 acceptable tests AND the difference between the best VC values is equal to
or less than 150 ml.
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
66 Easy on-PC
Performing a Test
3.14 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 98
for details).
You can view the test result on the monitor screen as soon as you see
message "Session Complete! Great Job!" after performing a test.
a b c d
Fig. 3-38 Test results, system interpretation

a Pre-medication test results c System interpretation
b Quality grade d Post-medication test results and
deviation from Pre-test results
3.15 Retrospective Test Assessment, Entering Comments

Note
You must be logged in as a user to be able to enter a test
assessment and comments.
Changing the Trial Acceptability
The trial acceptability and ranking of tests can be changed retrospectively.

This means that you can make tests inacceptable that the system judged
acceptable and vice versa. You can also change the trial ranking (rank 1, 2 or
3).
Click a (Fig. 3-39).
Easy on-PC 67
Performing a Test
The test assessment icons b appear on the test results screen.
Fig. 3-39 Changing the trial acceptability
Follow these steps to make a test acceptable that the system judged
inacceptable:
Click the icon.
In the ensuing window, select the Acceptable check box.
Fig. 3-40 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. 3-41).
68 Easy on-PC
Performing a Test
Note
To assign ranks 1, 2 and 3, please start with rank 3, etc.
Fig. 3-41 Changing the trial ranking
Entering Comments
Click in the comment area or click .

Write the text in the window and click Save to close the window.
The text will appear in the comment area; the reviewer's name and the date
of the last review are displayed below the area.
Fig. 3-42 Entering comments
Easy on-PC 69
Hygiene, Cleaning, Maintenance, Disposal
4 Hygiene, Cleaning, Maintenance, Disposal
Hygiene
Caution
Risk of Infection
Thoroughly clean the sensor when you suspect it to be
contaminated.
Users with open wounds or contagious diseases must
wear gloves.
For the users own safety and to prevent cross-
contamination, wash hands after each patient.
The spiretteTM must be properly disposed of immediately
after use.
Cleaning
Warning
Shock HazardDisconnect the flow sensor from the PC
before cleaning.
A risk of infection is eliminated by disinfection of all contaminated surfaces.

For an efficient disinfection of the surfaces, thoroughly clean the device
first.
Do not use abrasive cleaning agents.
Wipe the flow sensor and the connection cable down with a cloth moistened
with alcohol (70% max.).
Caution
Equipment DamageLiquids must not be allowed to enter
the flow sensor. Sensors into which liquids have entered
must be checked by a service technician before they can be
reused.
70 Easy on-PC
Note
It is not necessary to clean the connection cable, unless it is
contaminated with blood or sputum. For disinfection, wipe
the cable down with a disinfectant. Do not immerse the
cable in liquids.
Maintenance
Before each use
Before each use, visually inspect the device, the cables, the tubing and the
sensor for signs of mechanical damage.
If you detect damage or impaired functions that may adversely affect the
safety of the patient or user, do not use the system before it has been
repaired.
The sensor does not require any routine maintenance.
Do not open the housing. There are no parts inside the housing that can be
maintained or repaired by the user.
Check Measuring Accuracy
With Syringe
Note
As an alternative, the calibration can be checked with a test
subject (see "With Test Subject" on page 72).
The Easy on-PC calibration can be checked with a syringe using the calibra-
tion check function. The American Thoracic Society (ATS) recommends that
the spirometer calibration be checked on a regular basis. Owing to the ultra-
sound technology used in the flow sensor, the device requires no calibra-
tion, 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 num-
ber 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.
Easy on-PC 71
Now execute one full inspiratory pump stroke followed by one full
expiratory pump stroke at moderate speed.
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 instruc-
tions in chapter "Troubleshooting Tips" on page 92. Should you not be able
to remedy the defect by following these instructions either, please consult
ndd or one of their representatives.
Fig. 4-1 Calibration syringe
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. 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, ).
72 Easy on-PC
a b c d e f g h
Fig. 4-2 BioCal Check main screen

a Sensor selection e Click to select the BioCal Subject
b Parameter value tabs f Click to select a parameter
c Deselect tests (remove check mark) g Click to display the graphic trends
d Click to conduct a new test h Click to add a new BioCal Subject
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.
Easy on-PC 73
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, 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.
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.
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 refer-
ence lines will be mean (precision range), upper limit and lower limit. The
upper and lower limits are +/- 2 SD (Standard Deviation).
74 Easy on-PC
Specifications of the BioCal-Check QC Grades
For each parameter (FEV1, FVC, FEV6, DLCO, VI, VA) an individual BioCal-
Check QC grade is calculated. Additionally the lowest grade of all parame-
ters is reported.
Bio-QC Limitation Additional Limitation

Grade
BA - -
BB 1 value outside 2SD -
BC 1 value outside 3SD -
>= 4 values outside 1SD only consecutive values on

same side of mean
>= 2 values outside 2SD only consecutive values on

same side of mean
BD
> 1 value outside 3SD -
>= 10 values, consecutive -

values on same side of
mean
BF < 20 baseline values -
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 concern-
ing the decommissioning of your equipment.
Easy on-PC 75
System Settings
5 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 (calibration verification)
Export (data export)
XML export.
Fig. 5-1 System settings menu
Configuration
These are the tabs of the Configuration menu

General
Test
Device
Report
Printer
EMR
Environment.
Fig. 5-2 Configuration menu, "General" tab
76 Easy on-PC
System Settings
General Tab
These are the tabs of the General tab:

Header
Storage
System Settings
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, max. size 260 x
80 pixel (bmp)) b
you open a window with information about the software program c.
a b c
Fig. 5-3 "Header" tab

a Fields for entry of the hospital/practice c Click to display information about the
name software program
b Click to search for an illustration (logo)
to display
Easy on-PC 77
System Settings
Storage Tab
This tab is protected with a password (password EOPTM or 8005). On this

tab you can
create a new database folder a
import a database b
export a database e
copy data (from/to a storage medium) c
perform a data backup f
select a target folder for the current tests g (path and name are shown
at d).
a b c d e f g
Fig. 5-4 Storage tab

a Click to create a new database folder e Click to export a database
b Click to import a database f Click to perform a data backup
c Click to copy data from/to a storage g Click to select the database folder
medium
d Path and name of the currently used
78 Easy on-PC
System Settings
System Settings Tab
On this tab
you select the units for length, temperature, weight, hemoglobin and
pressure a
you choose whether all options are to be visible on the Test and
Device tabs (even options not currently implemented in the device) b
select the language c.
a b c
Fig. 5-5 "System Settings" tab

a Click to select the units c Click to select the language
b Select check box to always view all pos-
sible test and device settings, or dese-
lect
Easy on-PC 79
System Settings
User Handling Tab
This tab is protected with a password (password EOPTM or 8005). On this

tab you can enter an ID for each user. To start the system, users are then
required to log on with their ID. Condition: the function is enabled with
"Enable user handling" (b, Fig. 5-6). All tests will be annotated with the user
who performed the test.
The ID of the user who is logged on is shown next to the time.
a b c
Fig. 5-6 User Handling tab

a Select line to edit logged on users c Select to enter a new user
b Select check box to enable/disable the
function
80 Easy on-PC
System Settings
Test Tab
The tab comprises the following sub-menus

General
FVC/FVL
SVC
MVV
Cal-Check
Provocation.
General Tab
a b c d e f gh i
Fig. 5-7 General tab

a Option buttons to select the value (Best g Select the check box to display the ratio
Value/Best Trial) parameter as a percentage value
b Click to select the predicted values for h Select the check box to display the per-
children centage deviation from predicted for
c Click to select the predicted values for bronchodilation tests; otherwise,
adults remove the check mark by clicking
d Select/deselect the system interpreta- again
tion i Boxes for entry of correction factors
e Curve selection criteria (see Note below)
f Select this check box, if you want to
stop tests manually
Note
The predicted normal is corrected by the factor i, if no
specific calculation is defined for the ethnic group in the
selected predicted normal publication.
Easy on-PC 81
System Settings
Note
The settings selected here affect the predicted normals, the
interpretation and the displayed parameter readings.
Note
When the "Best Value " option is selected, the values for the
"Best " column are determined as follows:
The IC, IRV, VT and ERV parameters are calculated from the
average of all accepted trials.
For PEF, PIF and the volume parameters, the best value is the
highest value from all accepted trials.
Ratios such as FEV1/FVC, FEF50 / VCmax , MTC1 are
recalculated.
All other parameters are taken from the highest ranked trial
(= 1).
FVC/FVL Tab
a b c d e
Fig. 5-8 "FVC / FVL tab

a Select FVC/FEC6 d Predicted values are represented by
b Select the test type points or as a range
c Click to select a parameter e Select one of the options if you wish to
print the lung age
Note
Additional information for FVC-FEV6 selection: FEV6
indicates the exhaled volume after 6 seconds. When set to
FEV6, the program stops the measurement after 6 seconds.
Several parameters such as FEF25, FEF50, FEF75 and FEF25-
75 are not reported with this selection.
82 Easy on-PC
System Settings
Note
The settings selected here affect the predicted normals, the
interpretation and the displayed parameter readings.
With Parameter Select c you open a window for selection of the parameters
to be calculated. Different parameters can be selected for the display and
for the printout.
Choose a parameter in the "Available" list a
click b to transfer it to the "Selected" list.
Follow these steps to remove a parameter from the list
select it in the "Selected" list c
click d to remove it from the list.
Click e to scroll the list up and down.
Note
The parameter selection relates to the current test only.
Different parameters can be selected for each test.
a b c d e a b c d e
Fig. 5-9 FVC tab
Easy on-PC 83
System Settings
SVC Tab
On this screen you determine the start condition for measurement of the
vital capacity: after a phase of tidal breathing or directly without an initial
tidal breathing phase.
You also select the parameters for the SVC measurement.
Fig. 5-10 SVC tab
MVV Tab
On this screen, you select the parameters for the MVV measurement.
Fig. 5-11 MVV tab
84 Easy on-PC
System Settings
Provocation Tab
You select the test protocol from this tab.
Fig. 5-12 Provocation tab
Easy on-PC 85
System Settings
Device Tab

Flow sensor (USB connector)
EasyOne
Selection
Flow Sensor Tab
On this tab you specify flow sensor port or let the system determine the port
automatically with Auto Detect, e.g., after installation of the driver. The tab
also presents detailed sensor information a.
a b c
Fig. 5-13 Flow sensor tab

a Detailed information about the flow c Click to auto detect the sensor port
sensor
b Click to select the sensor port
86 Easy on-PC
System Settings
EasyOne Tab

Status
Test Configuration
General Configuration
Report Configuration
Consult the EasyOne operator manual for details.
Fig. 5-14 EasyOne tab
Selection Tab
Select your preferred sensor type on this tab.
Fig. 5-15 Selection tab
Easy on-PC 87
System Settings
Report Tab
On the Report tab, you can:

display the Report Designer (Layout Editor, see "Report Designer" on
page 109)
load layouts (Load layout, also refer to www.ndd.ch. Application Note
"EasyOne Pro import Layout") b
save layouts (Export layout) c
select the files for an XML export d
a b c d
Fig. 5-16 Report tab

a Press to display the Report Designer d Press to select the data for an XML
b Press to load report layouts export
c Press to save (export) layouts
88 Easy on-PC
System Settings
Printer Tab
Here you choose the printer if you do not want to print the tests on the
default printer.
a b c
Fig. 5-17 Printer tab

a Select the default printer c Press to update the printer list
b Press to open the printer list
Easy on-PC 89
System Settings
EMR Tab
Here you select the EMR system and the corresponding settings (see "GDT
Interface" on page 103).
This tab also allows you perform a new installation of the program e.
Note
Administrator privileges are required for the new installation
of a program.
a b c d e
Fig. 5-18 "EMR" tab

a Enter the GDT ID. d Press button to search for the GDT
b Select the EMR system from the list. folder.
c Select the character set from the list. e Click to install a new EMR system.
90 Easy on-PC
System Settings
Environment Tab
On this tab you enter the ambient conditions. These will be overwritten by
values entered prior to the test (see "FVL Test (inspiratory and expiratory
measurement)" on page 38).
a b c d e f g
Fig. 5-19 Environment tab

a Boxes for entry of room temperature, e Case temperature of the flow sensor
relative humidity and altitude (above f Click to close the window, saving the
sea level) of the examination site data
b BTPS conversion factor g Recalculate BTPS conversion factor
c ATPS values will be used, yes/no (no (e.g. after a change of the ambient
BTPS conversion) conditions)
d Select the check box, if you do not want
to enter ambient conditions for two
hours or until a restart. Otherwise,
remove the check mark by clicking
again.
Easy on-PC 91
Troubleshooting Tips
6 Troubleshooting Tips
Should you encounter problems operating your spirometer, please consult
the table below for troubleshooting tips.
When the Easy on- Self-test failed Quit the program and
PC is switched on, restart. If you receive
you see the the same message
following error again, contact your
message on the Easy on-PC dealer.
display:
When you start a The spirette is not Ensure that the

test, you see the correctly positioned. triangle on the
message spirometer is lined up
spirette. with the triangle on the
spirette.
Calibration check The spirette is not Insert the

outside of 3.5 %. correctly positioned. spirette as
described in section
"Preparing the Flow
Sensor" on page 24.
You have not used an Use the ndd

ndd adapter. calibration adapter.
There are leaks in the Check the

syringe connection. connections.
The specified syringe Choose the correct

volume differs from syringe volume via
the actual syringe Configuration > Test >
volume. Cal-Check.
Note
The most recent information and frequently asked questions
can be found on our web site at www.ndd.ch.
92 Easy on-PC
Specifications
7 Specifications
Measurement ultrasound transit time measurement

principle
Measuring volume: 2 % or 0.050 l

accuracy flow 2 % or 0.020 l/s, (except PEF)
PEF 5 % or 0.200 l/s
MVV 5 % or 5 l/min
Measuring volume: 12 l
range flow 16 l/s
Resistance less than 0.3 cm H2O/l/s
Parameters FVC, FVL, slow VC, MVV, Pre/Post, FVC, MVV6, FEV6,
FEV1, FEV1/FVC, FEV1/VCmax,
FEV1/FEV6, FEF25 (MEF75), FEF50 (MEF50), FEF75
(MEF25), FEF25-75% (MEF25-75%), PEF, FET, FIVC, PIF,
ERV, IRV,
Pre/Post % variation, lung age
(only the most important parameters are listed)
Respiratory spirette respiratory tube

tube
Predicted NHANES III, Knudson_83, Knudson_76, Crapo,

values (adults) Morris, Hsu, Dockery (Harvard), Polgar, Gutierrez
(Canada), Eigen, Pereira, Pereira 2006/2008, Prez-
Padilla (PLATINO), Prez Padilla (Mexico), Prez
Padilla (Mexico, Ped.), Chile 2010, 1997, ERS (ECCS/
EGKS), Zapletal 1977, Zapletal 2003, Stanojevic 2009
(GLI), Quanjer 2012 (GLI), Rosenthal, Austria 1988,
Austria 1994, Sapaldia (Swiss), Roca (Spain, SEPAR),
Vilozni 2005, Falaschetti, Klement (Russia),
Hedenstrm (Sweden), Gulsvik, (Norway), Berglund,
Birath (Sweden), Langhammer (Norway), Finnish,
Nystad, Hibbert, Gore, Crockett, Ethiopia, Asia 1-4,
JRS 2001, Fukuda Standard
Predicted Dockery (Harvard), Hsu, Zapletal, Polgar, Hibbert

values
(children)
Report format A4 (210 mm x 297 mm)
Operating temperature 0 to 40 C (32 to 104 F)

conditions relative humidity 5% to 95%,
(sensor) atmospheric pressure 500 hPa to 1060 hPa
Easy on-PC 93
Specifications
Storage temperature -20 to 50 C (-4 to +122 F)

relative humidity 5% to 95%,
atmospheric pressure 500 hPa to 1060 hPa
Certifications CE Declaration of Conformity
Device type BF applied part

classification device not suitable for operation in the presence of
(sensor) flammable, gaseous anesthetic agents, mixtures with
O2, or NO
Life time 7 years
94 Easy on-PC
Technical Description
8 Technical Description
PC/Laptop Requirements
The Easy on-PC software is installed on a PC or laptop computer to which

the flow sensor is connected by means of a USB cable.
The PC or laptop computer which is not part of the equipment supplied by
ndd Medizintechnik AG is thus considered a requisite accessory necessary
for the intended use of the device.
In your capacity as the operator of the medical electrical device you are
obliged to ensure that the specific, applicable requirements of the standard
EN 60601-1:2006 are complied with. The following conditions must be met:
All equipment operated in the patient environment must meet the
requirements of IEC 60601-1.
All equipment set up outside the patient environment must meet the
requirements of the applicable IEC or ISO safety standards (e.g. IEC
60950-1).
Fig. 8-1 Patient environment
If IEC XXXXX devices (devices that do not fulfill the requirements of IEC
standard 60601-1) are operated in the patient environment, it must be
ensured that the maximum allowed touch currents will not be exceeded.
These are the applicable limits:
normal condition: 100 A
with interruption of the (not permanently connected) protective earth
conductor: 500 A.
Appropriate measures must be taken, if these limits are exceeded.
Suggestions:
additional protective earth connection of the PC or
isolating transformer for the PC or
Easy on-PC 95
Technical Description
isolating transformer with built-in power outlet strip for the PC and the
devices connected to it.
Note
EN 6060-1:2006 specifies the requirements for power outlet strips.
Bear in mind that the touch currents may vary with the system
configuration.
Warning
Patient Hazard, Equipment DamageDo NOT modify the flow
sensor unless authorized by the manufacturer.
PC Maintenance
Back up the data on a regular basis.

Regular safety updates (incl. anti-virus software, firewall) are mandatory
for computers integrated in a data network.
The calibration must be checked after each update.
Warning
Equipment DamageViruses and malware may degrade the
Easy on-PC software performance. Therefore the PC must be
protected by adequate measures, such as anti-virus software
or a firewall.
Note
If updates of the operating system are performed
automatically (e.g Windows updates), we recommend
checking the calibration on a regular basis (see "With Test
Subject" on page 72).
96 Easy on-PC
Order Information
9 Order Information
2700-3 Easy on-PC, software program incl. accessories and

packaging
2050-1 spirette standard, case of 50
2050-5 spirette standard, case of 200
2030-2 Calibration syringe with calibration adapter
Easy on-PC 97
Appendix
10 Appendix
10.1 Interpretation
The automatic system interpretation can be selected and deselected on the
configuration tab (see c, "General Tab" on page 81).
GOLD-Hardie Interpretation
The following diagram outlines the criteria EasyOne Pro applies in the
automatic interpretation after GOLD/HARDIE (see "Literature" on page 132).
98 Easy on-PC
Appendix
NLHEP Interpretation
The following diagram outlines the criteria EasyOn PC applies in the auto-
matic interpretation after NLHEP (see "Literature" on page 132, [4]).
Note: 1. LLN = Lower limit of normal

2. If FEV6 is selected instead of FVC, FEV6 will be used for the interpreta-
tion instead of FVC.
3. If the selected predicted value publication does not define a lower
limit of normal (LLN), LLN is calculated as predicted value - 1.645 x
RSD (residual standard deviation). If RSD is not defined, the LLN for
FEV1/FVC is set at 90% of the predicted value, the LLN for FEV1 at
80% of the predicted value and the LLN for FVC at 80% of the predic-
ted value.
4. If the quality grade is D and the results are within the limits, the fol-
lowing interpretation will be output: "normal spirometry, insufficient
test quality, data not suitable for comparison".
Easy on-PC 99
Appendix
NICE Interpretation
Predominantly used in Great Britain. Source unknown.
1) FER = FEV1/FVC
NICE 2010 Interpretation
COPD Management of chronic obstructive pulmonary disease in adults in

primary and secondary care (partial update). NICE clinical guideline 101.
The NICE 2010 interpretation according to this algorithm (Fig. 10-1) does
not detect restrictive disorders. Our application, however, always identifies
restrictive disorders if FVC and FEV1 < LLN.
100 Easy on-PC

Appendix
Fig. 10-1
Easy on-PC 101

Appendix
System Interpretation Messages
Printed Text
No interpretation, not enough acceptable maneuvers
Normal Spirometry
Mild Obstruction
Moderate Obstruction
Severe Obstruction
Very Severe Obstruction
Restriction probable; further examinations recommended.
Normal Spirometry; at COPD risk
No interpretation, no predicted values
10.2 Predicted Values

Note
For the most recent predicted value sets and other pertinent
information, please visit our website at http://www.ndd.ch.
102 Easy on-PC

Appendix
10.3 GDT Interface
Introduction
The following describes the interface set up to facilitate the data

communication between Easy on-PC and an Electronic Medical Record
System (EMR). As an example the integration of the German GDT standard is
described.
Software Settings
The following settings need to be made in the Configuration menu:
Parameter Description
GDT Folder The GDT folder of the EMR system. This may also be a folder in a network
drive. For convenient path entry the Browse button may be used. The
GDT file will be written to this folder and read in from this folder.
Computer Name Name of the EMR computer.
Export single If this check box is selected, additionally the best values will be included
measurement value as single measurement values.
Easy on-PC 103

Appendix
Example: EMR Application "TurboMed"
TurboMed Software Settings
The following settings have to be applied only when the EMR interface is
used.
Start TurboMed software and select the record of a patient.
In the patient record select "Konsultationen / Gerteanbindung".
Select "Gert anbinden".
Enter the following:
Field Entry Description
Name Easy on-PC Name of equipment
Program c:\nddmed\EasyWarePro.exe Complete path of EasyWare software.
Export File c:\nddmed\nddturbomed.gdt Name and path of the export file.
Import File c:\nddmed\turbomedndd.gdt Name and path of the import file. The path (in
the example c:\nddmed\) must be identical
with the export file path.
Type 2 Version of the GDT / EMR interface
Confirm the entry with: Save.

Confirm the Gerte anbinden dialog with Ende.
These adjustments are sufficient for the set up of the EMR software. Now
proceed with the set up of Easy on-PC.
Setup Easy on-PC Software
When the EMR interface is used for the first time, the following settings have
to be made:
Start Easy on-PC.
Open the menu Utilities / Configuration / EMR.
Enter the path of the EMR folder according to the export path set in EMR
TurboMed (in the above example c:\nddmed\).
Enter the EMR computer name as "TurboMed".
Confirm the dialog with OK.
Close Easy on-PC.
104 Easy on-PC

Appendix
Performing a Measurement
The following describes the test procedure.

Start TurboMed, select a patient and open that file.
Select Konsultationen / Gerteanbindung.
Select Easy on-PC and then Start.
The patient data entry window appears automatically.
Enter the required data.
Confirm with OK.
Select the appropriate test type (FVC, FVL, SVC, MVV) and confirm with
Enter.
Perform a complete test with the patient.
Print a report if required.
Finish EMR (sends data to EMR and closes Easy on-PC).
TurboMed now receives the data.
Confirm with OK.
Close the program now with Ende.
Data accepted by Easy on-PC from EMR / GDT
The following data is read in by Easy on-PC from the GDT interface. The data
that is actually transmitted depends on the EMR (GDT) system used.
Excessive data is ignored by Easy on-PC.
GDT Field ID Description Comment
8000 Record ID
8316 GDT-ID of EMR
3000 Patient ID The ID may include letters and

numbers. Maximum length: 15
3101 Name Last Name, maximum number of

characters: 47
3102 First Name First name, maximum number of

characters: 47
3103 Date of Birth
Easy on-PC 105

Appendix
3110 Gender (1 = male)
3622 Height (in cm)
3623 Weight (in kg)
Here is an example of a GDT file (nddPCS.gdt), received from an EMR with

the name PCS:
01380006302
014810000202
0158315Extern
0128316PCS
014921802.00
01030001
0093100
0143101Meier
0163102Manfred
017310301011966
0093104
019310624106 Kiel
0203107Schulstr. 1
01031101
0123622185
011362363
In addition to some GDT specific information the file contains the following
patient information: Name, date of birth, gender, height in cm, weight in kg.
106 Easy on-PC

Appendix
Viewing tests with Easy on-PC
View test via GDT record type 6311 with patient name, ID and date and
time of test
Record type 6311 is supported. In the transmission of test results using GDT
record type 6310, field IDs 8432 (date) and 8439 (time) are always
included:
8432ddmmyyyy (day, month, year)
8439hhmmss (hours, minutes, seconds)
In case of a recall via GDT record type 6311, the test can be identified by
patient name, ID, test date and test time.
Example "forced expiratory spirometry"
Here the example transmission GDT Export with a forced loop test (FVL). The
data marked grey will be exported only when the "Export single
measurement value" check box is selected.
01380006310
014810001385
0128315EDV
0128316NDD
014921802.00
01230006-0
0183101Appeldorn
0173102Heinrich
017310323101945
01031101
0123622178
011362366
0158402LUFU02
017620024042008
017843224042008
017843918210004
0366228Your FEV1 / Predicted: 103%
0096228
0436228----------------------------------
0436228 Pre
0436228Parameter Pred Best %Pred
0436228----------------------------------
0436228FVC L 4.72 4.03 85
0436228FEV1 L 3.55 3.67 103
0436228FEV1/FVC 0.75 0.91 121
Easy on-PC 107

Appendix
0436228FEF25-75% L/s 2.88 5.55 193

0436228PEF L/s 9.09 10.60 117
0436228FET s - 4.12 -
0436228FIVC L 4.72 3.67* 78
0436228PIF L/s - 9.38 -
0586228* indicates: below LLN or significant post change.
0096228
0408410SN:DT 200076:633446580643340000
0348470Predicted Set: NHANES III
0378470System Interpretation Set: -
0096227
0128410FVC
0128411FVC
01384204.03
0108421L
0138410FEV1
0138411FEV1
01384203.67
0108421L
0178410FEV1/FVC
0178411FEV1/FVC
01384200.91
0098421
0188410FEF25-75%
0188411FEF25-75%
01384205.55
0128421L/s
0128410PEF
0128411PEF
014842010.60
0128421L/s
0128410FET
0128411FET
01384204.12
0108421s
0138410FIVC
0138411FIVC
01484203.67*
0108421L
0128410PIF
0128411PIF
01384209.38
0128421L/s
108 Easy on-PC

Appendix
10.4 Report Designer
Starting the Report Designer
On the initial screen, select Utilities.

Select Configuration.
In the Configuration menu, select the Report tab.
On the Report tab, select the Layout Editor..
Fig. 10-2 "Report" tab
Adding a Logo to an Existing Test
On the Report Designer tab, select New Report (Fig. 10-3 left).
Fig. 10-3 New Report button (left), test selection (right)
Select the test to which you want to add the logo (Fig. 10-3 right).
Easy on-PC 109

Appendix
Select the Picture Box (Fig. 10-4).
Fig. 10-4 Picture Box button
Insert the frame in the appropriate position (Fig. 10-5).
Fig. 10-5 Positioning the frame
110 Easy on-PC

Appendix
Select Image and click to open the Explorer (Fig. 10-6) .
Fig. 10-6 Image button
Select the logo. (Fig. 10-6). The logo will appear in the frame.
Save the test under a new name.
Configuring the Graphic Representation of an Existing Test
Select the test via New Report or Open.
Fig. 10-7 New Report, Open buttons
Select Windows and then Report Explorer (Fig. 10-8).

Select Detail Report Graph (Fig. 10-8).
Click graphVT1.
Easy on-PC 111

Appendix
Fig. 10-8 Windows, Report Explorer, Detail Report Graph buttons
Click the small arrow in the upper right corner of the "Detail Report
Graph" window (Fig. 10-8).
Click Run Designer. The Spiro Graph Configuration window will be dis-
played (Fig. 10-10).
Fig. 10-9 Detail Report Graph window
Select Test Type.

Choose options in the Trial Selection pane.
Choose options in the Appearance pane..
Fig. 10-10 Fenster Spiro Graph Configuration
Close the window with OK.

Save the test under a new name.
112 Easy on-PC

Appendix
10.5 Electromagnetic Compatibility (EMC)

Changes or modifications to the Easy on-PC not expressly approved by ndd
could cause EMC issues with this or other equipment. The Easy on-PC
system is designed to comply with applicable regulations regarding EMC. Its
compliance with these requirements has been verified. It needs to be
installed and put into service according to the EMC information stated as
follows.
Warning
Use of portable phones or other radio frequency (RF)
emitting equipment near the system may cause
unexpected or adverse operation.
The equipment or system should not be used adjacent to,
or stacked with, other equipment. If adjacent or stacked
use is necessary, the equipment or system should be
tested to verify normal operation in the configuration in
which it is being used.
Guidance and Manufacturers Declaration Electromagnetic Emissions
The Easy on-PC is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that the Easy on-PC is used in
such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions to Group 1 The Easy on-PC uses RF energy only for its
EN 55011 internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions to Class B The Easy on-PC is suitable for use in all

EN 55011 establishments, including domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Easy on-PC 113

Appendix
Guidance and Manufacturers Declaration Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment -

Level Guidance
Electrostatic 6 kV contact 6 kV Floors should be wood,

discharge (ESD) 8 kV air 8 kV concrete or ceramic tile. If
to EN 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least
30 %.
Electrical fast 2 kV for power the product

transient/burst supply lines has no power
to EN 61000-4-4 1 kV for input/ cords or input/
output lines output lines
Surge to EN 1 kV differential the product

61000-4-5 mode has no power
2 kV common cords
mode
Voltage dips, < 5 % UT the product

short (> 95 % dip in UT) for has no power
interruptions 0.5 cycles cords
and voltage 40 % UT
variations on (60 % dip in UT) for 5
power supply cycles
input lines to
EN 61000-4-11 70 % UT
(30 % dip in UT) for
25 cycles
< 5 % UT
(> 95 % dip in UT) for
5s
Power frequency 3 A/m passed Power frequency magnetic

(50/60 Hz) fields should be at levels
magnetic field to characteristics of a typical
EN 61000-4-8 location in a typical
commercial or hospital
environment.
NOTE UT is the AC mains voltage prior to application of the test level.
114 Easy on-PC

Appendix
Guidance and Manufacturers Declaration Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance Electromagnetic

Level Environment - Guidance
Portable and mobile RF

communications equipment
should be used no closer to
any part of the Easy on-PC,
including cables, than the
recommended separation
distance calculated from the
Conducted RF to 3 Vrms 3V equation applicable to the
EN 61000-4-6 150 kHz to 80 MHz frequency of the transmitter.
Radiated RF to 3 V/m 3 V/m Recommended separation
EN 61000-4-3 80 MHz to 2.5 GHz distance:
d = 1.2 P
d = 1.2 P 80 MHz to
800 MHz
d = 2.3 P 800 MHz to
2.5 GHz
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site
surveya, should be less than
the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol
Easy on-PC 115

Appendix
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which
the Easy on-PC is used exceeds the applicable RF compliance level above, the Easy
on-PC should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating
the Easy on-PC.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile

RF communications equipment and the Easy on-PC
The Easy on-PC is intended for use in the electromagnetic environment on which
radiated RF disturbances are controlled. The customer or the user of the Easy on-PC can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Easy on-PC
as recommended below, according to the maximum output power of the
communications equipment.
rated separation distance according to frequency of transmitter

maximum
output [m]
power
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of
d = 1.2 P d = 1.2 P d = 2.3 P
transmitter
[W]
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.7 3.7 7.37
100 11.7 11.7 23.3
116 Easy on-PC

Appendix
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Compliant Cables and Accessories
The Easy on-PC has no accessories that affect EMC compliance.
Easy on-PC 117

Appendix
10.6 Quick Reference Guide to the Screen Displays
Initial Screen
Click to perform a test

Click to select a patient or
admit a new patient Click to review the results from
previous tests
Click to modify the Help

system settings button Click to quit
the program
Selected patient 'Sensor connected'
indicator
Also refer to
"Safety Information" on page 7

"Start-up and Preparation" on page 15
"Performing a Test" on page 26
"System Settings" on page 76
"Index" on page 135
118 Easy on-PC

Appendix
Selecting/Admitting a Patient
Filter Last Name; by entering one or more letters,

Bar cursor for patient you limit the number of patients to those meeting
selection the filter criteria
Click to clear the filter
criterion
Click to admit a new Click to view all the 'Sensor Help

patient patient's tests connected' button
indicator Click to display
Click to the menu
Click to perform a test Click to edit the delete the options
with the selected patient patients data patient data
Also refer to
"Selecting/Admitting a Patient" on page 26

"Editing Patient Daa" on page 61
"Index" on page 135
Easy on-PC 119

Appendix
Admitting a Patient
Click to generate
Press the TAB or Enter key Click to open the tabs. automatic patien
after each entry. Click to select the ID.
Click to select ethnic origin.
the gender
Help
Click to close the button
window without saving
the data 'Sensor connected' Click to display
indicator the menu
options
Click to close the window,
saving the data
Also refer to
"Selecting/Admitting a Patient" on page 26

"Editing Patient Daa" on page 61
"Index" on page 135
120 Easy on-PC

Appendix
Test Menu
Note
The content of this menu depends on the device
configuration.
Click to select a test
Click to view patient data Help button

Selected Back to main
patient menu
'Sensor connected'
indicator
Also refer to
"Selecting a Test" on page 31

"Forced Vital Capacity (FVC/FVL)" on page 32
"Vital Capacity (SVC)" on page 42
"Maximum Voluntary Ventilation (MVV)" on page 45
"Index" on page 135
Easy on-PC 121

Appendix
Viewing Ambient Conditions
Ambient conditions
Click to recalculate BTPS
Selected Click to view patient data Help Back to

'Sensor button main
patient
connected'
menu
Click to close the window indicator
without saving the data
Click to close the window,
saving the data
Also refer to
"FVL Test (inspiratory and expiratory measurement)" on page 38

"Easy on-PC Sensor Design and Operation" on page 13
"Index" on page 135
122 Easy on-PC

Appendix
Retrieving/Printing Stored Tests
Test with Post-test data Click to view patients
Click column header to sort the list
Selected Click to view Help

Click to view trend
patient patient data button
Back
information
to
Click to view the test main
Click to Show print
'Sensor connected' menu
preview, print the test
indicator
Also refer to
"Retrieving/Printing Stored Tests" on page 54

"Quality Messages / Grades (Details)" on page 62
"Index" on page 135
Easy on-PC 123

Appendix
FVC Test Result
Click to select Click to select a new patient

curve display Click to conduct a
Predicted values
new test
Click to select Click to view the test list
the scale Click to enter a
test evaluation
Help button
Selected Click to view
patient patient data Back to main
'Sensor connected' menu
Click to view the indicator
test
Also refer to

"Index" on page 135
124 Easy on-PC

Appendix
Provocation Test Results
Protocol steps Test diagram

Protocol Next step to complete Measured values
in tabular form
Test result
Selected Help
Click to view
patient patient data Back to main
Sensor connected
menu
indicator
Also refer to
"Index" on page 135
Easy on-PC 125

Appendix
Print Preview
Selected test report

Click to select other Click to print the report
report layouts Click to display a submenu
with zoom, export, viewing
and print functions
Help button
Selected Click to view
patient patient data 'Sensor connected' indicator
Also refer to

"Index" on page 135
126 Easy on-PC

Appendix
Trend Display
Option buttons for selection of the view

Displayed parameter labels
Click to select a parameter Icon to initiate the
trend printout
Help button
Click to view
Selected patient data 'Sensor connected' indicator
patient
Also refer to
"Trend View" on page 57

"Hygiene, Cleaning, Maintenance, Disposal" on page 70
"Index" on page 135
Easy on-PC 127

Appendix
System Settings Menu
Click to display the

configuration menu Click to perform the Click to export data
calibration check
Help button
Click to view Back to
Selected patient data 'Sensor connected'
indicator main
patient
menu
Also refer to

"Index" on page 135
128 Easy on-PC

Appendix
Configuration Menu
Click to display more tabs
Click to search for an

Text boxes for entry of Click to view details about
illustration to be added
the header texts the software program
or removed
Selected Click to view 'Sensor connected' Help

patient patient data indicator button
Also refer to

"Index" on page 135
Easy on-PC 129

Appendix
Calibration Check
Calibration check with test subject

Calibration check with syringe
Click to view Help button

Selected patient data
patient
'Sensor connected' Back to
indicator main menu
Also refer to
"With Syringe" on page 71

"Specifications" on page 93
"Index" on page 135
130 Easy on-PC

Appendix
Calibration Check with Test Subject
Click to select the

Select the sensor BioCal Subject Click to add a new
Click to select the BioCal Subject
parameter for display
Deselect a test
(remove check mark)
Click to display the Help

Selected Click to view graphic trends
patient button
patient data
Back to main menu
Click to display the
baseline / control values Click to conduct a new test
Also refer to
"With Test Subject" on page 72

"Specifications" on page 93
"Index" on page 135
Easy on-PC 131

Appendix
10.7 Literature
[1] American Thoracic Society. Standardization of Spirometry: 1994
Update, Nov. 11,1994. Am J Resp Crit Care Med 1995; 152:1107-
1136.
[2] Occupational Health and Safety Administration (OSHA), Pulmonary
Function Standards for Cotton Dust, 29 CFR: 1910.1043 Appendix D.
[3] Social Security Administration Disability (SSD) Guidelines, CFR404:
Appendix 1 to Subpart P.
[4] Ferguson GT, Enright PL, Buist AS, et al. Office spirometry for lung
health assessment in adults: A consensus statement from the
National Lung Health Education Program. Chest 2000; 117:1146-
1161.
[5] ATS Pulmonary Function Laboratory Management and Procedure
Manual, American Thoracic Society, New York, NY 10019.
[6] Enright PL, Hyatt RE. Office Spirometry. Lea & Febiger, Philadelphia,
1987.
[7] Hyatt, RE, Scanlon PD, Nakamura M. Interpretation of Pulmonary
Function Tests - A Practical Guide. Lippincott - Raven, Philadelphia,
1997.
[8] American Thoracic Society. Lung Function Testing: Selection of
Reference Values and Interpretative Strategies, Am Rev Respir Dis
1991; 144:1202-1218.
[9] Morris JF, Temple W. Short Report: Spirometric "Lung Age"
Estimation for Motivating Smoking Cessation, Preventive Medicine
14. 655-662 (1985).
[10] Polgar, Promadhat, Pulmonary Function Testing in Children:
Techniques and Standards. W.B. Saunders Co., Philadelphia, 1971.
[11] M.R. Miller, R. Crapo, J. Hankinson, et al. ATS/ERS Task Force:
Standardization of Lung Function Testing. Numbers 1 to 5. Eur Respir
J 2005; 26: 153-161, 319-338, 511-522, 720-735, 948-968.
[12] Global Strategy For The Diagnosis, Management, And Prevention Of
Chronic Obstructive Pulmonary Disea-se, Executive Summary,
Updated 2003 (GOLD).
[13] Hardie et.al., Risk of over-diagnosis of COPD in asymptomatic
elderly never-smokers Eur Respir J2002;20: 1117-1122.
[14] ATS/ERS Task Force: Standardization of Lung Function Testing Eur
Respir J 2005;26:153161.
132 Easy on-PC

Appendix
[15] N. Beydon, S.D. Davis et al.; An Official American Thoracic Society/

European Respiratory Society Statement: Pulmonary Function Test-
ing in Preschool Children. Am J Respir Crit Care Med Vol 175. pp
13041345, 2007.
Easy on-PC 133

Appendix
134 Easy on-PC

Index
Index
A F
Ambient conditions . . . . . . . . . . . . . . . 38 FEV6 . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Ambient conditions, enter . . . . . . . . . . 91 Flow sensor . . . . . . . . . . . . . . . . . . . . . .13
ATPS values. . . . . . . . . . . . . . . . . . . . . . 38 Forced vital capacity . . . . . . . . . . . . . . .32
FVC . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
FVL test (inspiratory and expiratory mea-
B
surement) . . . . . . . . . . . . . . . . . . . . . . .38
BioCal Check . . . . . . . . . . . . . . . . . . . . . 72
BioCal Check QC grades. . . . . . . . . . . . 75
Bronchial provocation G
introduction and safety information GDT interface . . . . . . . . . . . . . . . . . . . 103
47 General Tab . . . . . . . . . . . . . . . . . . . . . .77
performing a test . . . . . . . . . . . . . 48 GOLD-Hardie Interpretation . . . . . . . . .98
safety information . . . . . . . . . . . . 10
Bronchodilation . . . . . . . . . . . . . . . . . . 39
H
BTPS values. . . . . . . . . . . . . . . . . . . . . . 38
Header Tab. . . . . . . . . . . . . . . . . . . . . . .77
Hygiene . . . . . . . . . . . . . . . . . . . . . . . . .70
C
Calibration adapter. . . . . . . . . . . . .71, 97
I
Calibration syringe . . . . . . . . . . . . .71, 97
Initial screen . . . . . . . . . . . . . . . . . . . . .25
Caution (definition) . . . . . . . . . . . . . . . . 8
Installation with Windows 7 . . . . . . .16
CE marking . . . . . . . . . . . . . . . . . . . . . . . 5
Installation with Windows XP . . . . . .20
Check Measuring Accuracy . . . . . . . . . 71
Intended use . . . . . . . . . . . . . . . . . . . . .12
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . 70
Interpretation. . . . . . . . . . . . . . . . . . . . .98
Comments, enter . . . . . . . . . . . . . . . . . 67
Interpretation, NICE. . . . . . . . . . . . . . 100
Configuration . . . . . . . . . . . . . . . . . . . . 76
Interpretation, NLHEP . . . . . . . . . . . . . .99
D L
Danger (definition) . . . . . . . . . . . . . . . . . 8
Licence terms . . . . . . . . . . . . . . . . . . . . .5
Data backup . . . . . . . . . . . . . . . . . . . . . 78
Literature . . . . . . . . . . . . . . . . . . . . . . 132
Data, copy . . . . . . . . . . . . . . . . . . . . . . . 78
Logo, add to test . . . . . . . . . . . . . . . . 109
Database folder, create . . . . . . . . . . . . 78
Lung function test, select . . . . . . . . . . .81
Definition of the parameters . . . . . . . . 59
Disposal . . . . . . . . . . . . . . . . . . . . . . . . 75
Driver installation . . . . . . . . . . . . . . . . . 21 M
Maintenance . . . . . . . . . . . . . . . . . . . . .71
E Maximum Voluntary Ventilation. . . . . .45
Merging patient records . . . . . . . . . . . .30
EasyOne tab . . . . . . . . . . . . . . . . . . . . . 87
MVV . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Electromagnetic Compatibility. . . . . . 113
MVV tab . . . . . . . . . . . . . . . . . . . . . . . . .84
EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
EMR Tab. . . . . . . . . . . . . . . . . . . . . . . . . 90
Equipment checks before each use . . 71 N
Expiratory FVC measurement . . . . . . . . 32 New patient, admit . . . . . . . . . . . . . . . .29
NICE Interpretation . . . . . . . . . . . . . . 100
Easy on-PC 135

Index
NLHEP Interpretation . . . . . . . . . . . . . . 99 T
Technical description . . . . . . . . . . . . . .95
O Test assessment, retrospective . . . . . .67
Order Information . . . . . . . . . . . . . . . . . 97 Test, end . . . . . . . . . . . . . . . . . . . . . . . .53
Test, print. . . . . . . . . . . . . . . . . . . . . . . .54
Test, retrieve . . . . . . . . . . . . . . . . . . . . .54
P Test, selection . . . . . . . . . . . . . . . . . . . .31
Parameter definitions. . . . . . . . . . . . . . 70 Trend view . . . . . . . . . . . . . . . . . . . . . . .57
Parameter, select . . . . . . . . . . . . . . . . . 83 Troubleshooting . . . . . . . . . . . . . . . . . .92
Patient data, edit . . . . . . . . . . . . . . . . . 61
Patient, selection . . . . . . . . . . . . . .26, 27
PC maintenance . . . . . . . . . . . . . . . . . . 96 W
Post-test . . . . . . . . . . . . . . . . . . . . . . . . 39 Warning (definition) . . . . . . . . . . . . . . . .8
Predicted values . . . . . . . . . . . . . . . . . 102 Warranty. . . . . . . . . . . . . . . . . . . . . . . . . .7
Pre-test . . . . . . . . . . . . . . . . . . . . . . . . . 39
Printer Tab. . . . . . . . . . . . . . . . . . . . . . . 89
Provocation tab. . . . . . . . . . . . . . . . . . . 85
Q
Quality grade. . . . . . . . . . . . . . . . . . . . . 36
Quality grades. . . . . . . . . . . . . . . . . . . . 62
Quality messages . . . . . . . . . . . . . . . . . 62
Quick Test . . . . . . . . . . . . . . . . . . . . . . . 53
R
Revision history . . . . . . . . . . . . . . . . . . . 6
S
Safety information
bronchial provocation . . . . . . . . . 10
Screen displays, quick reference . . . 118
Selection tab. . . . . . . . . . . . . . . . . . . . . 87
Sensor, connect . . . . . . . . . . . . . . . . . . 21
Software installation . . . . . . . . . . . . . . 15
Specifications . . . . . . . . . . . . . . . . . . . . 93
spirette, insertion . . . . . . . . . . . . . . . . . 24
Spirometry trial, add. . . . . . . . . . . . . . . 37
Storage Tab . . . . . . . . . . . . . . . . . . . . . . 78
SVC . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
SVC tab . . . . . . . . . . . . . . . . . . . . . . . . . 84
System interpretation. . . . . . . . . . . . . . 67
System requirements . . . . . . . . . . . . . . 14
136 Easy on-PC

Index
Easy on-PC 137

ndd Medical Technologies ndd Medizintechnik AG
2 Dundee Park Technoparkstr. 1
Andover, MA 01810 CH-8005 Zurich,
USA Switzerland
www.nddmed.com www.ndd.ch

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What safety information is provided regarding the device?

What safety information is provided regarding the device?

Easy on-PC

2 Start-up and Preparation 15

4 Hygiene, Cleaning, Maintenance, Disposal 70

1.1 CE Marking Information

1.2 Licence Terms

The software and the accompanying product documentation may not be

1.3 Revision History

1.4 Manual Purpose

1.5 Intended Audience

1.7 Safety Information

This manual is an integral part of the device. It should be available to the

In this manual the safety information is classified as follows:

any element of doubt concerning the safety of connected

Risk of InfectionProper use of the spirette provides a

physical and sensitizing stimuli in adults. Report Working

Observe to the information given in the Operator Manual.

CE marked per the Medical Device Directive 93/42/EEC of

The number found under this symbol is the date of

Type BF applied part

This symbol indicates that the waste of electrical and

1.8 Intended Use

1.9 Description of the Medical Electrical Device

Fig. 1-1 Medical electrical device

1.10 Easy on-PC Sensor Design and Operation

integrated mouthpiece ultrasound sensor 2 ultrasound sensor 1

Fig. 1-2 Flow sensor

1.11 System Requirements

operating system Windows 7, Windows 8, 1), Windows

Connector) and units with serial numbers

Web browser Internet Explorer 6 or later

processor Intel -/Pentium processor or

monitor resolution 1024 x 600

hard drive memory installation/system: 1 GB

Beyond the minimum requirements, a larger RAM of >1 GB and a larger

2 Start-up and Preparation

2.1 Software Installation

Installation with Windows 7

Confirm with I Agree.

Click Next >.

Option: Installing .NET Framework 4 (if not already installed)

Confirm with Finish.

When this dialog is displayed, select Restart Now.

Installation with Windows XP

System requirements: Windows XP SP3.

Users with Admin privileges should clear the Protect my computer ..

Install .NET Framework 4 and restart the computer if prompted to do so.

2.2 Connecting the Flow Sensor

Answer the prompt Can Windows connect to Windows Update to search

Accept the proposed driver and click Finish.

Click OK to save the new COM port.

2.3 Preparing the Flow Sensor

Fig. 2-15 Inserting the spirette

2.4 Starting the Software Program

Fig. 2-16 Initial screen

3.1 Selecting/Admitting a Patient