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EasyOneAir Operators Manual V01 EN

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0% found this document useful (0 votes)

133 views143 pages

EasyOneAir Operators Manual V01 EN

Uploaded by

Alexandru Mart

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

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new diagnostic design

EasyOne Air
Operator’s Manual
V01

9000007_00
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
Preface

1 Preface

1.1 Revision history of the EasyOne Air Operator’s Manual

Revision date Version Description

02 February 2017 V01 Initial release for market launch
 Revision history of the EasyOne Air Operator’s Manual

1.2 Identification and revision of the EasyOne Air spirometer

This revision V01 of the EasyOne Air Operator’s Manual applies to

EasyOne Air with a serial number greater than 1,000,000 and with a firmware
version greater than V1.5.0.
If you are in doubt whether this revision of the Operator’s Manual applies to
your particular EasyOne Air sensor, please contact the ndd Servicing
Department.
You can find the most recent revision of this Operator’s Manual on the
ndd website.
 Contact information, 4
On www.ndd.ch
For the US, on www.nddmed.com

1.3 Version history of the EasyOne Connect PC software

A comprehensive version history of EasyOne Connect is available on the ndd

website. Simply search for “version history” on the ndd website.
EasyOne Air requires EasyOne Connect V3.0 or later.
 On www.ndd.ch
For the US, on www.nddmed.com

1.4 Intended use of the EasyOne Air spirometer

The EasyOne Air spirometer is intended for prescription use only to conduct
diagnostic spirometry testing of adults and pediatric patients over 4 years
old. The EasyOne Air spirometer is used by general practitioners, specialists,
and health care professionals, in hospitals and clinics, in pharmacies, and in
clinical settings in occupational medicine.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

1.5 Intended audience of this Operator’s Manual

This Operator’s Manual is intended for general practitioners, specialists, and

health care professionals. General practitioners, specialists, and health care
professionals are expected to have working knowledge of medical
procedures, practices, and terminology as required to conduct or interpret
diagnostic spirometry tests.

1.6 Using this Operator’s Manual

Read this Operator’s Manual prior to operating EasyOne Air and

EasyOne Connect.
Store the Operator’s Manual in a safe and easily accessible place.

1.7 Application Notes for further information

You can find further information on specialized topics in Application Notes on

the ndd website.
 http://AppNotes.ndd.ch
For the US, http://AppNotes.nddmed.com

1.8 Legal information

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, ndd new diagnostic design and EasyOne are registered trademarks of
ndd Medizintechnik AG.
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
PCL® is a registered trademark of Hewlett-Packard Development Company, L.P.
Wi-Fi® is a registered trademark of Wi-Fi Alliance.
Microsoft and Windows are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

1.9 About electromagnetic interference

This device complies with part 15 of the FCC rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference,
and (2) this device must accept any interference received, including
interference that may cause undesired operation.
For the US, see 47 Code of Federal Regulations Sec. 15.19(a)(3)
This Class B digital apparatus complies with Industry Canada RSS standards.
For Canada, see RSS-Gen — General Requirements for Compliance of Radio
Apparatus

1.10 Contact information

ndd Medizintechnik AG ndd Medical Technologies

Technoparkstrasse 1 300 Brickstone Square, Suite 604
CH-8005 Zurich, Switzerland Andover, MA 01810, USA
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

1.11 Product registration

Registering EasyOne Air facilitates the handling of warranty claims.

To register EasyOne Air, go to the ndd website.
 http://reg.ndd.ch
For the US, http://reg.nddmed.com

1.12 Disposal

In the European Union, the product you have purchased should not be disposed of as
unsorted municipal waste. Please make use of your local WEEE collection facilities to
dispose of this product and otherwise observe all applicable requirements.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

1 Preface 2
Revision history of the EasyOne Air Operator’s Manual . . . . . . . . . . . . . . . . . 2
Identification and revision of the EasyOne Air spirometer . . . . . . . . . . . . . . . 2
Version history of the EasyOne Connect PC software . . . . . . . . . . . . . . . . . . . 2
Intended use of the EasyOne Air spirometer . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Intended audience of this Operator’s Manual . . . . . . . . . . . . . . . . . . . . . . . . . 3
Using this Operator’s Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Application Notes for further information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Legal information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
About electromagnetic interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contact information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Product registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 Safety information 11
Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Safety information regarding electromagnetic compatibility . . . . . . . . . . . . 14
About requirements for connections to external devices . . . . . . . . . . . . . . . 15
List of equipment icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3 First-time setup 17
List of box contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
About compatible printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Setting up the physical components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Setting up the EasyOne Air spirometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Installing or updating the EasyOne Connect software on your PC . . . . . . . . 25

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 5/143 10
4 Introduction 26
Introduction to the EasyOne Air spirometer. . . . . . . . . . . . . . . . . . . . . . . . . . 26
Overview of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
About using the touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Overview of the user interface of EasyOne Air . . . . . . . . . . . . . . . . . . . . 29
Introduction to the EasyOne Connect software . . . . . . . . . . . . . . . . . . . . . . . 33
Overview of features of EasyOne Connect . . . . . . . . . . . . . . . . . . . . . . . 33
Overview of the user interface of EasyOne Connect. . . . . . . . . . . . . . . . 34
List of terms and definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
List of tests and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
About sources for predicted normal values . . . . . . . . . . . . . . . . . . . . . . . . . . 39

5 Cybersecurity 40
About cybersecurity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
About password policies and password expiration. . . . . . . . . . . . . . . . . . . . 40
About periodical software updates and patches . . . . . . . . . . . . . . . . . . . . . . 41
About backups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Escalating in case of a security breach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Dealing with a lost or stolen EasyOne Air or PC . . . . . . . . . . . . . . . . . . . . . . . 42
Using EasyOne Air securely – general guidelines . . . . . . . . . . . . . . . . . . . . . 43

6 Connectivity and data exchange 44

About connectivity between EasyOne products. . . . . . . . . . . . . . . . . . . . . . . 44
About integration of EMR systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
About supported EMR standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
About possible workflows with your EMR system . . . . . . . . . . . . . . . . . 45
About using EasyOne Air to process orders . . . . . . . . . . . . . . . . . . . . . . 46
Overview of the integration process. . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Overview of the plug-ins for EMR systems . . . . . . . . . . . . . . . . . . . . . . . 47
About the HL7 plug-in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
About the GDT plug-in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
About the XML file exchange plug-in . . . . . . . . . . . . . . . . . . . . . . . 48
About custom plug-ins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Working with your EMR system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Processing orders from your EMR system . . . . . . . . . . . . . . . . . . . 49
Initiating a spirometry test with the direct-start workflow . . . . . . 50
Sending individual test results to your EMR system . . . . . . . . . . . 51

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 6/143 10
7 Performing spirometry 52
Overview of the spirometry workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
About preparation of spirometry and instructions for the patient . . . . . . . . 53
About quality messages for trials and quality grades for tests . . . . . . . . . . 54
About posts and bronchodilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Performing spirometry using EasyOne Air stand-alone. . . . . . . . . . . . . . . . . 55
Choosing a test and adding a new patient . . . . . . . . . . . . . . . . . . . . . . 55
Choosing a test and selecting an existing patient . . . . . . . . . . . . . . . . 56
About the summary screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Performing a complete test using EasyOne Air stand-alone . . . . . . . . . 58
Performing spirometry using EasyOne Connect in combination with
EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Connecting EasyOne Air to EasyOne Connect . . . . . . . . . . . . . . . . . . . . 64
Performing a complete test using EasyOne Connect together with
EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
About interpreting results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
List of quality messages and quality grades . . . . . . . . . . . . . . . . . . . . . . . . . 72
About quality messages and quality grades . . . . . . . . . . . . . . . . . . . . . 72
List of quality messages for trials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
List of quality grades for tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

8 Breathing maneuvers for all available tests 76

About breathing maneuvers for all available tests . . . . . . . . . . . . . . . . . . . . 76
Performing the breathing maneuver for the FVC test. . . . . . . . . . . . . . . . . . . 76
Performing the breathing maneuver for the FVL test . . . . . . . . . . . . . . . . . . . 77
About the OSHA test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
About the SSA test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Performing the breathing maneuver for the MVV test . . . . . . . . . . . . . . . . . . 79
Performing the breathing maneuver for the SVC test . . . . . . . . . . . . . . . . . . 80

9 Hygiene and cleaning 81

Avoiding contamination while performing spirometry . . . . . . . . . . . . . . . . . 81
List of cleaning solutions for EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

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10 Working with patient data and reports 83
Working with patient data and reports on EasyOne Air. . . . . . . . . . . . . . . . . 83
Adding a patient to the database on EasyOne Air . . . . . . . . . . . . . . . . . 83
Editing patient data on EasyOne Air. . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Deleting a patient from the database on EasyOne Air. . . . . . . . . . . . . . 84
Exporting data from EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Viewing and printing reports on EasyOne Air . . . . . . . . . . . . . . . . . . . . 86
About the reports menu and the history menu . . . . . . . . . . . . . . . . . . . 86
Working with patient data and reports in EasyOne Connect . . . . . . . . . . . . . 87
Adding patient data to the database of EasyOne Connect . . . . . . . . . . 87
Editing patient data with EasyOne Connect . . . . . . . . . . . . . . . . . . . . . . 87
Merging two patient data records with EasyOne Connect . . . . . . . . . . . 88
Deleting patient data from the database of EasyOne Connect . . . . . . . 88
Copying patient data between EasyOne Air and EasyOne Connect . . . 89
Viewing and printing reports with EasyOne Connect. . . . . . . . . . . . . . . 90
About the trend view with EasyOne Connect . . . . . . . . . . . . . . . . . . . . . 91
Assessing tests retrospectively and entering comments with
EasyOne Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
About exporting comprehensive data from EasyOne Connect . . . . . . . 92
About exporting XML from EasyOne Connect . . . . . . . . . . . . . . . . . . . . . 92
About exporting from EasyOne Connect to EasyWare . . . . . . . . . . . . . . 93

11 Configuration 94
Configuration of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Configurations in the settings menu of EasyOne Air . . . . . . . . . . . . . . . 94
Description of device settings of EasyOne Air . . . . . . . . . . . . . . . . 94
Description of spirometry settings of EasyOne Air . . . . . . . . . . . . 95
Description of display settings of EasyOne Air . . . . . . . . . . . . . . 100
Description of print settings of EasyOne Air . . . . . . . . . . . . . . . . 101
Performing a firmware update with EasyOne Air . . . . . . . . . . . . . . . . . 102
Performing a backup of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . 103
About the information menu of EasyOne Air . . . . . . . . . . . . . . . . . . . . 104
About the user menu of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Configuration of EasyOne Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
About saving or discarding configuration changes of EasyOne Connect . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
About user handling and the default password of EasyOne Connect . 106
Description of general configurations of EasyOne Connect . . . . . . . . 106
Utilities > Configuration > General > Header . . . . . . . . . . . . . . . . 106
Utilities > Configuration > General > Storage . . . . . . . . . . . . . . . 107
Utilities > Configuration > General > System Settings . . . . . . . . 107
Activating user handling and administering user accounts . . . . 107
Description of test configurations of EasyOne Connect . . . . . . . . . . . 108

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

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Utilities > Configuration > Test > General . . . . . . . . . . . . . . . . . . 108
Utilities > Configuration > Test > Predicted . . . . . . . . . . . . . . . . . 109
Recalculating predicted values of previous test results . . . . . . . 113
Utilities > Configuration > Test > FVC / FVL . . . . . . . . . . . . . . . . . 114
Utilities > Configuration > Test > SVC . . . . . . . . . . . . . . . . . . . . . 115
Utilities > Configuration > Test > MVV . . . . . . . . . . . . . . . . . . . . . 115
Utilities > Configuration > Test > CalCheck . . . . . . . . . . . . . . . . . 115
Utilities > Configuration > Test > Provocation . . . . . . . . . . . . . . . 116
Description of device configurations of EasyOne Connect . . . . . . . . . 116
Description of report configurations of EasyOne Connect. . . . . . . . . . 116
Loading and selecting a custom report layout of EasyOne Connect . . 117
Description of printer configurations of EasyOne Connect . . . . . . . . . 117
Description of environment configurations of EasyOne Connect . . . . 118

12 Calibration check 119

About calibration check with EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Performing a calibration check with EasyOne Air . . . . . . . . . . . . . . . . . . . . 120

13 Servicing and troubleshooting 122

About charging the battery of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . 122
Checking for correct operation of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . 122
List of troubleshooting solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
About reactivating EasyOne Air after storage . . . . . . . . . . . . . . . . . . . . . . . 124
Exporting logging information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

14 Specifications and bibliography 125

List of specifications for EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
List of specifications for the lithium-ion battery of EasyOne Air. . . . . . . . . 128
List of order numbers and accessories for EasyOne Air . . . . . . . . . . . . . . . 130
List of system requirements for EasyOne Connect. . . . . . . . . . . . . . . . . . . . 131
List of bibliographic references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

15 Index 133

A Appendix 139
Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

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EMC conformance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Compliant cables and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Wireless module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Electromagnetic emission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

2 Safety information

2.1 Classification

In this manual, safety information is classified as follows:

WARNING
WARNING …
… indicates a hazard. If not avoided, the hazard can result in death or serious
injury.

CAUTION
CAUTION …
… indicates a potential hazard. If not avoided, the hazard may result in minor
injury and/or product/property damage.

2.2 General safety information

Electric Shock Patients and technicians may be exposed to dangerous voltage.

Connect only medical-grade power supply released by the manufacturer.
To ensure electric safety, connect only equipment, such as printers and net-
works, that complies with the IEC 60950-1 standard for the electrical safety of
IT equipment.

Patient health Inadequate qualification of personnel who operate EasyOne Air can put the
hazard patient’s health at risk.
The patient may suffer an asthma attack or a bronchospasm while performing
spirometry.
EasyOne Air must only be used by qualified personnel.
Do not leave the patient unattended while performing spirometry or in be-
tween trials.
Intended audience of this Operator’s Manual, 3

Cross- After use, the disposable EasyOne Flow Tube can be infectious.
contamination and Provide means for proper disposal of infectious waste, according to legal re-
adverse reaction quirements.

False diagnosis Inadequate qualification of the personnel that operates EasyOne Air can lead
to false results, false interpretation, and false diagnosis.
EasyOne Air must only be used by qualified personnel.
Intended audience of this Operator’s Manual, 3

Electric shock Do not open EasyOne Air.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Fire Follow the manufacturer’s recommendation for proper disposal of the battery.
Only use an original battery by the manufacturer.
Do not store EasyOne Air close to flammable materials like paper or textiles.
Disposal, 4
List of order numbers and accessories for EasyOne Air, 130

False diagnosis EasyOne Air may be damaged when dropped or during transport.
Perform an incoming inspection when you first receive EasyOne Air. If you de-
tect any damage, contact your EasyOne Air dealer or the ndd Servicing Depart-
ment.
Especially check the battery for visible damage before use.
Do not drop EasyOne Air.
If EasyOne Air has been dropped, check for correct operation of EasyOne Air.
Checking for correct operation of EasyOne Air, 122

Fire due to explosive If used in the vicinity of flammable gases, the plastic case may catch fire and
or flammable gases cause burn injuries to the patient.
For preventive measures, make sure that the device is not used near flamma-
ble gases (for example, anesthetic agents).
If not in daily use, remove the battery from EasyOne Air and store the battery
in the original packaging.

False diagnosis Environment conditions outside the range described in the specifications can
cause measurement errors.
Use EasyOne Air only within the defined environment specifications for tem-
perature, humidity, and atmospheric pressure/altitude.
Observe the limits of storage conditions.
Setting up the EasyOne Air spirometer, 24
List of specifications for EasyOne Air, 125
Configuration of EasyOne Air, 94
List of specifications for EasyOne Air, 125
About reactivating EasyOne Air after storage, 124

False diagnosis Setup with wrong environment data can cause false results.
Verify the environment data that you have set up.

False diagnosis Electromagnetic fields from other devices may cause disturbances in
EasyOne Air.

False diagnosis Graphs on the display of EasyOne Connect may be misleading due to unclear
curve scaling between different patients.
Only conduct result interpretation of curves with a printed report.
About interpreting results, 71
List of quality messages and quality grades, 72

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Failed update An update may fail.

Perform backups of the database of EasyOne Air and EasyOne Connect fre-
quently.
Performing a backup of EasyOne Air, 103

Data loss Data loss may occur for various other reasons and is generally unpredictable.
Backup the database of EasyOne Air frequently.
Performing a backup of EasyOne Air, 103

False diagnosis For unforeseen reasons, malfunction of EasyOne Air can lead to false results.
Perform calibration checks periodically.
Calibration check, 119
Checking for correct operation of EasyOne Air, 122

Malfunction Viruses, malware, and other hazardous software on your PC may adversely af-
fect the performance of EasyOne Connect.
Install anti-virus software on your PC.

Malfunction Damaged components can lead to false results.

Make sure that no liquid penetrates into EasyOne Air, for example through the
battery compartment or the USB port.

Leakage of acids Do not connect the battery improperly.

and explosion Do not throw the battery into fire.
Remove the battery from the battery compartment if you do not intend to use
EasyOne Air for a longer period.
Avoid mechanical shock to the battery.
If the rechargeable battery is damaged, liquids from the battery must not get
into contact with skin or eyes. In case of contact with skin or eyes, rinse thor-
oughly with water and consult a physician.
Only charge the battery using EasyOne Air, the power supply released by the
manufacturer, and the cradle.
Follow the manufacturer’s recommendation for proper disposal of the battery.
About charging the battery of EasyOne Air, 122
Disposal, 4

Malfunction Servicing must only be carried out by ndd staff or by qualified service person-
nel of official ndd distributors.
Do not open EasyOne Air.

Malfunction Non-original accessories and disposables, like respiratory tubes, battery,

power adapter, or cables can cause malfunction.
Only use original accessories and disposables by the manufacturer.
List of order numbers and accessories for EasyOne Air, 130

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False diagnosis Non-original respiratory tubes can cause measurement error and false results.
You must only use EasyOne Flow Tube respiratory tubes by the manufacturer to
assure accuracy, long-life, and full warranty coverage.
List of order numbers and accessories for EasyOne Air, 130

Excessive heat Prolonged exposure to direct sunlight, for example in cars, or exposure to oth-
er sources of heat may cause the battery to explode.
Do not store in places that can exceed temperatures of 50°C or 122°F.
Remove the battery and store the battery in the original packaging.

Network connection Connection of EasyOne Connect to an IT network that includes other equip-
ment could result in previously unidentified risks to patients, operators, or
third parties.
Subsequent changes to the IT network could introduce new risks and require
additional analysis.
Changes to the IT network include:
• changes in the IT network configuration,
• connection of additional items to the IT network,
• disconnecting items from the IT network,
• update of equipment connected to the IT network, and
• upgrade of equipment connected to the IT network.
It is your responsibility to identify, analyze, evaluate, and control these risks.
IEC 80001-1:2010 provides guidance to address these risks.

2.3 Safety information regarding electromagnetic compatibility

Influence by HF Electrical devices with a high RF power output during intended use (e.g. High
surgical equipment frequency (HF) surgical equipment) should not be operated in parallel with
EasyOne Air.

Portable wireless Portable wireless communications equipment such as wireless home network
communications devices, mobile phones, cordless telephones and their base stations, walkie-
equipment talkies, etc. can affect EasyOne Air.
Keep a distance of at least 30 cm (12 inches) to any part of EasyOne Air.

Increased emissions Accessories, transducers, and cables other than those specified by the manu-
or decreased facturer or replacement parts for internal components may result in increased
immunity emissions or decreased immunity of EasyOne Air.

Proximity to other EasyOne Air should not be used adjacent to or stacked with other equipment.
equipment Should close proximity or stacking be unavoidable, however, the configura-
tion in which it is used needs to be watched closely to ensure that the equip-
ment is functioning normally.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Interruption of the Electrical fast transient coupling to the USB cable or electrostatic discharge on
USB connection the device may cause an interruption of the USB connection, which is indicat-
ed to the user. After reconnecting, the USB connection will work as expected.
There is no harm because the data transmission is secured.
 Electromagnetic Compatibility (EMC), 139

2.4 About requirements for connections to external devices

EasyOne Connect is installed on a PC or laptop, to which EasyOne Air is

connected via the cradle or wirelessly.
The PC or laptop is not part of the equipment supplied by the manufacturer
and is considered a requisite accessory that is necessary to use EasyOne Air
with the PC software EasyOne Connect.
In your capacity as the operator of the medical electrical device you are
obliged to ensure that the specific, applicable safety requirements for the
operation of a medical-electrical device 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).

 Patient environment
If 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.
The following limits are applicable:
• normal condition: 100 μA
• with interruption of the (not permanently connected) protective earth
conductor: 500 μA
Appropriate measures must be taken if these limits are exceeded.
Operator’s Manual • EasyOne Air • EasyOne Connect • V01
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 15/143 16
Safety information

Suggestions:
• additional protective earth connection of the PC or
• isolating transformer for the PC or
• isolating transformer with built-in power outlet strip for the PC and the
devices connected to it
EN 60601-1:2006 specifies the requirements for power outlet strips.
Bear in mind that the touch currents may vary with the system configuration.

2.5 List of equipment icons

Follow instructions for use.

Do not reuse (single-patient use).

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

Product certification for the USA and Canada.

Medical electric equipment that includes a radio frequency transmitter

and emits non-ionizing radiation.

Date of manufacture—the number found under this icon is the date of

manufacture.

Manufacturer

Caution: Federal law restricts this device to sale by or on the order of a

licensed healthcare practitioner.
In the European Union, the product you have purchased should not be
disposed of as unsorted municipal waste. Please make use of your local
WEEE collection facilities to dispose of this product and otherwise
observe all applicable requirements.
Instrument classification: Type BF applied part

Universal Serial Bus (USB)—standard for data transfer, connecting

devices, and battery charging, applies to cables and connectors

Battery

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3 First-time setup

3.1 List of box contents

The box contains the following items:

A EasyOne Flow Tube respiratory tubes B EasyOne Air spirometer

 Box contents – top inlay

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

B
C
G
D

A Battery B USB Bluetooth adapter

C USB flash drive D 2x USB cable
E Nose clip F ndd power supply
G Cradle

 Box contents – bottom inlay

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

A USB cable micro to type A B USB cable micro to type B

 The different USB connectors of the two USB cables

The box contains the following documents:
• The EasyOne Air Quick Guide
• Certificate of Stability
The USB flash drive contains the following:
• The EasyOne Air Operator’s Manual
• The EasyOne Air Quick Guide
• Instructional movies
• The EasyOne Connect PC software

3.2 About compatible printers

EasyOne Air can print over USB when using the cradle.
To print via the cradle, the printer must support the protocols Direct PDF,
Postscript, or HP PCL 3 Enhanced.
EasyOne Connect can use any printer that is installed on your PC. To print
using EasyOne Connect, connect the printer to your PC and not to the cradle.
 Description of print settings of EasyOne Air, 101
Setting up the physical components, 20
Application Note Printer Compatibility List
Application Notes for further information, 3

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3.3 Setting up the physical components

WARNING
ELECTRIC SHOCK
Patients and technicians may be exposed to dangerous voltage.
Connect only medical-grade power supply released by the manufacturer.
To ensure electric safety, connect only equipment, such as printers and net-
works, that complies with the IEC 60950-1 standard for the electrical safety of
IT equipment.

CAUTION
ELECTRIC SHOCK, PATIENT HEALTH HAZARD, AND FALSE DIAGNOSIS
Damage to casing or broken components may expose the patient or technician
to dangerous voltage. Small parts from damaged disposables can be ingested
or inhaled by the patient. Measurement errors can cause false diagnosis.
Check the device and especially the battery for visible damage before on-site
installation and before usage.

1 Unpack EasyOne Air and the battery.

2 Unlock and open the battery compartment by turning the lock screw
clockwise.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3 Insert the battery into the battery compartment of EasyOne Air.

 The battery fits easily into the compartment. If the battery does not
seem to fit, check the correct insert direction. Do not apply force.

4 Close and lock the battery compartment by turning the lock screw
counterclockwise.

5 Unpack the cradle and the USB cables.

6 Turn the cradle around so that the back of the cradle is facing towards you.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7 If you want to connect the cradle to a printer, do the following:

a) Connect the smaller plug of the USB cable micro to type B to the left USB
port of the cradle (marked with the printer/PC icon).
b) Connect the larger plug of the USB cable micro to type B to the
corresponding USB port of your printer.

8 If you want to connect the cradle to a PC, do the following:

a) Connect the smaller plug of the USB cable micro to type A to the left USB
port of the cradle (marked with the printer/PC icon).
b) Connect the larger plug of the USB cable micro to type A to a USB port of
your PC.
 You can connect the cradle either to a PC or to a printer. If you connect
the cradle to a PC, you can use EasyOne Connect to print.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

9 For charging EasyOne Air, always connect the ndd power supply:
a) Plug the ndd power supply into a power outlet.
b) Connect the cable of the ndd power supply to the right USB port of the
cradle (marked with the plug icon).

 Setting up the EasyOne Air spirometer, 24

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3.4 Setting up the EasyOne Air spirometer

Prerequisite
 You have set up the physical components
Setting up the physical components, 20
1 Turn on EasyOne Air.

 The region selection screen is displayed.

2 Select your region from the world map.
 The language selection screen is displayed.
3 Select your language from the language selection list.
4 Select the date and time format.
5 Enter the date and time and choose Next.
 If the battery is removed for more than 8 hours, your need to reenter
date and time.
 Configuration of EasyOne Air, 94
Description of print settings of EasyOne Air, 101

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3.5 Installing or updating the EasyOne Connect software on your PC

The procedure for installing EasyOne Connect is the same as for updating
EasyOne Connect. If EasyOne Connect is already installed on your PC, the ndd
SmartInstaller performs an update.
Prerequisite
 Your PC meets the system requirements for EasyOne Connect.
List of system requirements for EasyOne Connect, 131
CAUTION
FAILED UPDATE
An update may fail unnoticed.
After performing an update, restart EasyOne Air and EasyOne Connect and per-
form a calibration check.
Calibration check, 119
Checking for correct operation of EasyOne Air, 122

1 Connect the USB flash drive from the box contents to your PC.
2 Choose the file SmartInstaller.exe.
 The User Account Control of Microsoft Windows is displayed and asks
for confirmation.
3 In the User Account Control window, choose Yes.
 The ndd SmartInstaller is displayed.
4 Choose Install Software.
 The required software packages are automatically determined.
5 When required, choose Next repeatedly.
6 When the license agreement is displayed, read the license agreement,
select I Agree, and choose Next.
 EasyOne Connect and all required software packages are installed.
7 After the installation has finished, choose Close and/or OK.
 The installation is complete.
8 In the ndd SmartInstaller, choose Exit.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4 Introduction

4.1 Introduction to the EasyOne Air spirometer

4.1.1 Overview of EasyOne Air

The EasyOne Air spirometer

A
D

A EasyOne Flow Tube holder B Touchscreen

C Handles D Power button

 Top-view of EasyOne Air

A Speaker B USB port to connect to the cradle

C Lock screw for battery compartment D Battery compartment

 Bottom-view of EasyOne Air

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

When EasyOne Air is turned on and not in use, the screensaver and automatic
power-off function are activated to save battery power. You can change the
default configuration in the following menu:
> > > Screensaver after and Power-off after
A low battery message will alert you when battery power falls below 10%.
Data saved in non-volatile memory is not lost when battery power is low or
when batteries are removed.

The EasyOne Flow Tube respiratory tube for single-patient use

 The EasyOne Flow Tube respiratory tube

To ensure hygienic testing, the EasyOne Flow Tube respiratory tube is a
disposable for single-patient use. EasyOne Air recognizes the correct position
of the EasyOne Flow Tube in the EasyOne Flow Tube holder and gives feedback
if the EasyOne Flow Tube is not placed correctly. The EasyOne Flow Tube is
designed to work accurately with the ultrasonic sensor of EasyOne Air. For
reliable results, use only the original EasyOne Flow Tube by the manufacturer.

CAUTION
FALSE DIAGNOSIS
Non-original respiratory tubes can cause measurement error and false results.
You must only use EasyOne Flow Tube respiratory tubes by the manufacturer to
assure accuracy, long-life, and full warranty coverage.
List of order numbers and accessories for EasyOne Air, 130

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4.1.2 About using the touchscreen

There are some controls and gestures for the touchscreen, which you can use
throughout the system.

Controls and gestures for navigating on the touchscreen

To choose a button or to select a list item, tap on the button or list item on the
touchscreen. For every tap, you hear a clicking sound as audible feedback if
this function is enabled. Also for every tap, the area or the key that you have
tapped is highlighted as visible feedback.
To scroll through lists, a scroll bar is displayed on the right side of lists.
To move a slider on the touchscreen, drag your finger across the touchscreen.

Using the touchscreen with gloves

You can use the touchscreen wearing disposable gloves made of any
material. Standard disposable gloves used in hospitals and general
practioners’ offices work fine with the touchscreen.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4.1.3 Overview of the user interface of EasyOne Air

Basic interface elements are used throughout EasyOne Air for status
information and for navigation in the menus.

HIPAA compliance
EasyOne Air is compliant to the Health Insurance Portability and
Accountability Act. Access to EasyOne Air is password-protected. The internal
database of EasyOne Air is encrypted.

The home screen

The home screen is the starting point when working with EasyOne Air.

 The home screen of EasyOne Air

The home screen displays the following icons:

This icon is a shortcut to the most commonly performed test, the FVC
test.

In the more menu, you can choose from all available tests.

?
In the reports menu, you have access to the reports in chronological
order.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

In the patients menu, you have access to patient data and also to the
reports, which are sorted by patient here.

In the tools menu, you can configure EasyOne Air and perform
calibration checks and have access to settings and database
functionalities.

In the orders menu, you have access to orders for spirometry tests from
your EMR system.

The patients menu displays the following icons:

With the add patient button, you can add a patient to the database.

With the delete patient button, you can delete a patient from the
database.

With the edit patient data button, you can edit patient data.

In the history menu, you have access to patient data and results.

With the export button, you can export patient data and results.

The tools menu displays the following icons:

In the settings menu, you have access to various settings that are
listed in the table below.

In the calibration check menu, you can perform calibration checks to

verify that EasyOne Air is functioning correctly.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

In the update menu, you can perform firmware updates.

In the backup menu, you can backup the patient database, results and
configurations.

The information menu displays information about the currently

installed firmware.

In the user menu, you can configure individual users and their
passwords for login.

The settings menu displays the following icons:

In the device settings menu, you have access to device settings, like
speaker volume, empirical or metric units settings, date and time
settings, or Bluetooth settings.

In the spirometry settings menu, you have access to spirometry

settings, like predicted normal values, system interpretation, or the
automatic quality control setting.

In the display settings menu, you have access to settings like

language, date and time format, or settings for how results are
displayed.

In the print settings menu, you can configure the printer that is
connected to the cradle.

In the factory reset menu, you can reset the configuration of

EasyOne Air to its delivery status. However, the patient data will not be
deleted.

Configuration of EasyOne Air, 94

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

The status bar

The status bar on the top of the home screen displays basic status
information.

 The status bar on the top

The status bar displays the following icons:

Indicates that Bluetooth is enabled.

Indicates that Wi-Fi is enabled.

Indicates a connection to a printer.

Indicates a connection to a PC.

Indicates that an SD memory card is inserted.

Indicates that charging level of the battery is very low.

Indicates that EasyOne Air is connected to the ndd power supply and
currently charging. But the charging level is still low.

Indicates that EasyOne Air is connected to the ndd power supply and
currently charging. The charging level is at about 50%.

Indicates that EasyOne Air is connected to a power supply, but cannot

charge.
Check whether EasyOne Air is connected to the ndd power supply or to a
different USB power source.
Only use the ndd power supply.
Indicates that the health of the battery is low.
Consider replacing the battery.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

The < Back button and the home button

 The < Back button is at the bottom left-hand side, and the home button is at the
bottom in the middle.
In any menu, the < Back button is displayed at the bottom left and the home
button at the bottom middle of the touchscreen. To go back to the home
screen, choose the home button. To navigate back in menus, choose the
< Back button.

4.2 Introduction to the EasyOne Connect software

4.2.1 Overview of features of EasyOne Connect

EasyOne Connect offers the same features as EasyOne Air to perform

spirometry, to work with patient data, or to evaluate results, as well as some
additional features.
EasyOne Connect is especially helpful to work with patient data and to
evaluate results because you can use a full-size PC monitor and keyboard.
If you want to perform spirometry with EasyOne Air stand-alone, for example
off-site, EasyOne Connect enables you to enter all relevant patient data
beforehand and synchronize that data to EasyOne Air. Then, after you return
from performing spirometry, you can synchronize the test results back to
EasyOne Connect and evaluate the test results, print reports, and archive the
data on your PC.
To work efficiently with patient data and orders for spirometry tests, you can
link up EasyOne Connect with your EMR system.
 Connectivity and data exchange, 44

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4.2.2 Overview of the user interface of EasyOne Connect

Basic interface elements are used throughout EasyOne Connect for status
information and for navigation in the menus.

The main menu

The main menu is the starting point when working with EasyOne Connect.

 The main menu of EasyOne Connect

The main menu displays the following icons:

In the patients menu, you have access to patient data and also to the
reports.

In the test menu, you can choose from all available tests.

In the history menu, you have access to the reports in chronological order.

In the orders menu, you have access to orders for spirometry tests from your
EMR system.
This icon is only displayed if you have configured a connection to your EMR
system.
In the utilities menu, you can configure EasyOne Connect and perform
calibration checks and have access to settings and database
functionalities.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

The menu bar

The menu bar at the bottom of the screen is visible at all times. In the menu
bar, you can navigate back to the main menu and quickly access the active
patient data or this Operator’s Manual.

 The menu bar at the bottom of the screen

The menu bar displays the following areas:

This area displays the name and patient ID of the patient that
you have selected last. To view a summary of the patient’s
demographic data, choose this area.

To open the PDF file of this Operator’s Manual, choose ?.

With the menu area, you can navigate back to the main
menu. The label and function of this area varies between
menus.

4.3 List of terms and definitions

Term Definition
test Short for spirometry test.
A test is an examination that is defined by the breathing maneuver that the patient performs and by
the parameters that are calculated from the measured data.
For each test, a report exists.
trial The performing of one breathing maneuver.
A trial is part of a test.
curve For each trial, curves are plotted, e.g. a flow-volume curve and a volume-time curve.
parameter For each trial, parameters are calculated from its curve.
Parameters enable the diagnosis.
Scientific publications describe each parameter and predicted normal values for most of the
parameters. For a few parameters, only the parameters themselves, but no predicted normal values
have been published.
post Short for post bronchodilator.
A post is performed after the patient is treated with a bronchodilator. Prior to the medication, the
same test has been performed to be compared with the post.
bronchial Bronchial provocation tests are performed by administering increasing doses of an airway irritant.
provocation The reaction of the respiratory system to these substances is measured. For example, Mannitol and
Methacholine are available as provocative agents for a number of protocols.
protocol Either, the protocol defines the context of a test, that is whether it is a stand-alone test, a test
together with a post, or a bronchial provocation test. You can sort the history screen by protocol.
Or, the protocol describes the procedure of a bronchial provocation test. This protocol defines the
increasing doses of the provocative agent during the provocation test.
order Orders are related to EMR systems.
 Terms and definitions

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4.4 List of tests and parameters

The following tables give an overview of the relevant tests and parameters.
The parameters are established in the professional literature and constitute
the results of testing.

Test Test description Available parameters

FVC Forced expiratory vital capacity test BEV, EOTV, FEF10, FEF25, FEF25-75, FEF25-75/FVC, FEF40, FEF50,
FEF50/FVC, FEF60, FEF75, FEF80, FET, FET25-75, FEV.25, FEV.5,
FEV.5/FVC, FEV.75, FEV.75/FVC, FEV1, FEV1/FEV6, FEV1/FVC,
FEV3, FEV3/FVC, FEV6, FVC, FVC6, MEF20, MEF25, MEF40, MEF50,
MEF60, MEF75, MEF90, MMEF, PEF, PEFT, t0
FVL Flow volume loop test BEV, EOTV, FEF10, FEF25, FEF25-75, FEF25-75/FVC, FEF40, FEF50,
FEF50/FVC, FEF60, FEF75, FEF80, FET, FET25-75, FEV.25, FEV.5,
FEV.5/FVC, FEV.75, FEV.75/FVC, FEV1, FEV1/FEV6, FEV1/FIV1,
FEV1/FVC, FEV3, FEV3/FVC, FEV6, FIF25, FIF50, FIF50/FEF50, FIF75,
FIV.25, FIV.5, FIV1, FVC, FVC6, MEF20, MEF25, MEF40, MEF50,
MEF60, MEF75, MEF90, MIF25, MIF50, MIF75, MMEF, PEF, PEFT, t0
MVV Maximum voluntary ventilation test MVV, MVV6, MVVtime, Rf
SVC Slow vital capacity test ERV, IC, IRV, Rf, VC, VCex, VCin, VCmax, VT

 Tests

Parameter Parameter description Unit

BEV Back extrapolated volume L
BTPSex BTPS factor used for expiration –
BTPSin BTPS factor used for inspiration –
EOTV End of test volume L
ERV Expiratory reserve volume L
f Breathing frequency 1/min
FEF10 Forced expiratory flow at 10% of vital capacity—synonymous with MEF90 L/s
FEF25 Forced expiratory flow at 25% of vital capacity—synonymous with MEF75 L/s
FEF25-75 Forced expiratory flow from 25% to 75% of vital capacity—synonymous with MMEF L/s
FEF25-75/FVC Ratio of FEF25-75 to FVC 1/s
FEF40 Forced expiratory flow at 40% of vital capacity—synonymous with MEF60 L/s
FEF50 Forced expiratory flow at 50% of vital capacity—synonymous with MEF50 L/s
FEF50/FVC Ratio of FEF50 to FVC 1/s
FEF60 Forced expiratory flow at 60% of vital capacity—synonymous with MEF40 L/s
FEF75 Forced expiratory flow at 75% of vital capacity—synonymous with MEF25 L/s
FEF80 Forced expiratory flow at 80% of vital capacity—synonymous with MEF20 L/s
FET Forced expiratory time s
FET25-75 Forced expiratory time between FEF25 and FEF75 s
FEV.25 Forced expiratory volume after 0.25 seconds L

 Parameters

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Parameter Parameter description Unit

FEV.5 Forced expiratory volume after 0.5 seconds L
FEV.5/FVC Ratio of FEV.5 to FVC –
FEV.75 Forced expiratory volume after 0.75 seconds L
FEV.75/FVC Ratio of FEV.75 to FVC –
FEV1 Forced expiratory volume after 1 second L
FEV1/FEV6 Ratio of FEV1 to FEV6 –
FEV1/FIV1 Ratio of FEV1 to FIV1 –
FEV1/FVC Ratio of FEV1 to FVC –
FEV1/VC Ratio of FEV1 to VC (VC taken from SVC test) –
FEV3 Forced expiratory volume after 3 seconds L
FEV3/FVC Ratio of FEV3 to FVC –
FEV6 Forced expiratory volume after 6 seconds L
FIF25 Forced inspiratory flow at 25% of vital capacity—synonymous with MIF75 L/s
FIF50 Forced inspiratory flow at 50% of vital capacity—synonymous with MIF50 L/s
FIF50/FEF50 Ratio of FIF50 to FEF50 –
FIF75 Forced inspiratory flow at 75% of vital capacity—synonymous with MIF25 L/s
FIV.25 Forced inspiratory volume after 0.25 seconds L
FIV.5 Forced inspiratory volume after 0.5 seconds L
FIV1 Forced inspiratory volume after 1 second L
FIVC Forced inspiratory vital capacity L
FVC Forced expiratory vital capacity L
FVC6 Forced expiratory vital capacity after 6 seconds L
IC Inspiratory capacity from end of tidal breathing L
IRV Inspiratory reserve volume L
Lung Age calculated age of the average healthy individual who would perform similar to tested Years
patient on spirometry
MEF20 Mean expiratory flow at 80% of vital capacity—synonymous with FEF80 L/s
MEF25 Mean expiratory flow at 75% of vital capacity—synonymous with FEF75 L/s
MEF40 Mean expiratory flow at 60% of vital capacity—synonymous with FEF60 L/s
MEF50 Mean expiratory flow at 50% of vital capacity—synonymous with FEF50 L/s
MEF60 Mean expiratory flow at 40% of vital capacity—synonymous with FEF40 L/s
MEF75 Mean expiratory flow at 25% of vital capacity—synonymous with FEF25 L/s
MEF90 Mean expiratory flow at 10% of vital capacity—synonymous with FEF10 L/s
MIF25 Mean inspiratory flow at 75% of vital capacity—synonymous with FIF75 L/s
MIF50 Mean inspiratory flow at 50% of vital capacity—synonymous with FIF50 L/s
MIF75 Mean inspiratory flow at 25% of vital capacity—synonymous with FIF25 L/s
MMEF Mean mid-expiratory flow—synonymous with FEF25-75 L/s
MVV Maximum voluntary ventilation L/min
 Parameters

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Parameter Parameter description Unit

MVV6 Maximum voluntary ventilation for 6 seconds L/min
MVVtime Duration of the trial in seconds s
PEF Peak expiratory flow L/s
PEFT Time to peak flow s
PIF Peak inspiratory flow L/s
Rf Respiratory frequency 1/min
t0 Back-extrapolated start time of the trial s
VC Vital capacity, from slow expiration L
VCex Expiratory vital capacity, from slow expiration L
VCin Inspiratory vital capacity, from slow inspiration L
VCmax Highest VC value from all trials of one test L
VT Tidal volume L
 Parameters

4.5 List of abbreviations

Abbreviation Full form

ATPS Ambient temperature pressure saturated—refers to environment conditions, can be converted to BTPS
ATS American Thoracic Society
BTPS Body temperature pressure saturated—refers to converted environment conditions, can be converted
from ATPS
EHR Electronic health record—synonymous to EMR, used in EMR systems
EMC Electromagnetic compatibility
EMR Electronic medical record—synonymous to EHR, used in EMR systems
EMR system Computer software for handling electronic medical records
ERS European Respiratory Society
GDT Gerätedatentransfer—German EMR standard
GLI Global Lung Function Initiative
GOLD Global Initiative for Chronic Obstructive Lung Disease
HIPAA Health Insurance Portability and Accountability Act
HIS Hospital information system
HL7 Health Level 7—international EMR standard
LLN Lower limit of normal
NIOSH National Institute for Occupational Safety and Health
NLHEP National Lung Health Education Program
OSHA Occupational Safety and Health Administration
SD Standard deviation
SEE Standard error of the estimate
 Abbreviations

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Abbreviation Full form

SSA Social Security Administration
USB Universal Serial Bus (USB)—standard for data transfer, connecting devices, and battery charging,
applies to cables and connectors
 Abbreviations

4.6 About sources for predicted normal values

The available predicted normal values for EasyOne Air are updated as
required through software updates.
You can find the currently used sources for predicted normal values in the
document below.
 Application Note Reference Predicted Normal Values
Application Notes for further information, 3
Installing or updating the EasyOne Connect software on your PC, 25

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

5 Cybersecurity

EasyOne Air is protected against cyberattacks. However, to maintain security,

you must follow the guidelines that are laid out in this chapter.

5.1 About cybersecurity

EasyOne Connect can be installed on regular Windows PCs. The operating

institution is responsible for installing an antivirus software and a firewall on
the PC, for installing critical Windows updates regularly, and for keeping the
PC otherwise secure. EasyOne Connect does not run with Windows
administrator privileges.
EasyOne Air itself is not directly connected to the network.
EasyOne Connect can be connected to a network for various purposes, but can
also function stand-alone without network access. The file-based database is
encrypted. Alternatively, it is also possible to connect EasyOne Connect to an
SQL-server-based database.

5.2 About password policies and password expiration

You can use a combination of user name and password in order to control
access to EasyOne Connect. It is the responsibility of the operating institution
to apply the appropriate password policies (for example, password strength
and password renewal intervals).
EasyOne Connect does not include functionality for password strength and
password expiration requirements. In case user handling is deactivated a
default password is used to restrict access to certain functionalities.
Follow these general recommendations on password strength in case your
institution does not have a more specific policy:
• Use a minimum password length of 8 characters.
• Include lowercase and uppercase alphabetic characters, numbers and
symbols.
• Generate passwords randomly where feasible.
Follow this general recommendation for a password renewal interval in case
your institution does not have a more specific policy:
• Passwords should be renewed after 90 days.
 About user handling and the default password of EasyOne Connect, 106
Activating user handling and administering user accounts, 107

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

5.3 About periodical software updates and patches

For secure use, perform software updates regularly.

Contact your EasyOne dealer in order to receive regular notifications of
software updates, or visit the ndd website for information on updates.
 Installing or updating the EasyOne Connect software on your PC, 25
Performing a firmware update with EasyOne Air, 102
Contact information, 4

5.4 About backups

Whether or not EasyOne Connect performs backups automatically depends on

whether a file-based database or an SQL-server-based database is used.

When using a file-based database

EasyOne Connect includes a separate backup storage that automatically
stores the current database. The backup is performed each time
EasyOne Connect is shut down.
In addition, the manufacturer recommends that you regularly backup the
database manually to a different storage device and that you store this
additional backup in a separate location.

When using an SQL-server-based database

In this case, no automatic backup is performed. It is the operating
institution’s responsibility to perform backups of the SQL server regularly.
 Utilities > Configuration > General > Storage, 107
About exporting comprehensive data from EasyOne Connect, 92

5.5 Escalating in case of a security breach

In case a security breach has been detected in your institution, do the

following:
1 Immediately disconnect the PC that EasyOne Connect is installed on from
the network.
 After you have disconnected the PC that EasyOne Connect is installed
on from the network, you can no longer access an SQL server, but you can
work temporarily with a file-based database that is stored locally on your
PC.
2 Follow all other necessary procedures for a security breach as specified by
your institution’s IT department.
3 If you are uncertain whether EasyOne Air has been compromised, contact
the ndd Servicing Department.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

5.6 Dealing with a lost or stolen EasyOne Air or PC

In case EasyOne Air or the PC that EasyOne Connect is installed on has been
lost or stolen, do the following:
Prerequisite
 The manufacturer strongly recommends that you activate user handling
in order to prevent unauthorized persons from accessing the data stored
on EasyOne Air or in EasyOne Connect.
About the user menu of EasyOne Air, 105
About user handling and the default password of
EasyOne Connect, 106
Activating user handling and administering user accounts, 107
1 Immediately report the loss or theft of EasyOne Air or of the PC that
EasyOne Connect is installed on to the ndd Servicing Department.
 The ndd Servicing Department will ensure that your EasyOne Air or your
installation of EasyOne Connect is not unlocked unintentionally by ndd
staff for anyone else but you.
 Contact information, 4

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

5.7 Using EasyOne Air securely – general guidelines

The manufacturer strongly recommends that you follow these guidelines at all
times.
1 Activate user handling if unauthorized persons might have physical access
to EasyOne Air. To activate user handling, do the following:
a) Choose Utilties > Configuration > General > User Handling.
b) Enter the default password 8005 and choose Login.
c) To add a user, choose Add.
d) Fill out the User ID field, the Password field, and the Repeat Password
field.
e) Optionally, fill out the other fields.
f) Choose OK.
g) Select the User Handling check box.
h) Choose Save.
 User handling is activated. Now, users must log in to use EasyOne Air.
2 To prevent unauthorized access when EasyOne Air is unattended, activate
automatic log off. To activate automatic log off, do the following:
a) Choose Utilities > Configuration > General > User Handling.
b) Select the Screen times out after check box.
c) In the min field, enter the desired period of inactivity after which
automatic log off is to be activated.
d) Choose Save.
 After the period that you have set, EasyOne Air is locked and users must
log in again.
3 Only use network file transfer (pdf, HL7, XML, etc.) in trusted and secured
network environments.
4 In case you use an SQL-server-based database, it is the operating
institution’s responsibility to use appropriate measures to protect the SQL
server as well as the communication channel.
 Generally, SQL servers provide functionality for encrypted SSL
connections.
 The manufacturer does not take responsibility for the cybersecurity of
the communication channel or the data storage on the SQL server. The SQL
server is considered a third-party product and not within the scope of
EasyOne Air.
 About user handling and the default password of EasyOne Connect, 106
Activating user handling and administering user accounts, 107

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Connectivity and data exchange

6 Connectivity and data exchange

For data exchange, you can connect EasyOne products with the
EasyOne Connect PC software. In addition, you can interface EasyOne Connect
and EasyOne Pro/LAB with the information system in your hospital or practice.

6.1 About connectivity between EasyOne products

Easy on-PC

EasyOne Connect

Centralized
diagnostics
EasyOne Pro/LAB

EasyOne Air

 Connectivity between EasyOne products

All EasyOne products can connect to a shared comprehensive database
through the EasyOne Connect PC software. The EasyOne Pro/LAB respiratory
analysis system can connect to this shared database independently.
To enable connectivity between EasyOne products, the manufacturer
recommends to set up an SQL-server-based database.
After you have configured an SQL-server-based database, you can review
patient data and reports of all connected EasyOne products on any connected
PC with EasyOne Connect or on any EasyOne Pro/LAB. Access to the server-
based database is password-protected and requires a Microsoft Active
Directory user account.

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Connectivity and data exchange

For support with the configuration of an SQL-server-based database, contact

the ndd Servicing Department.
 Application Note EasyConnect – Database Connection
Application Notes for further information, 3
Utilities > Configuration > General > Storage, 107
Contact information, 4

6.2 About integration of EMR systems

6.2.1 About supported EMR standards

EasyOne Connect and EasyOne Pro/LAB can be interfaced with your EMR
system.
EMR systems are, for example, hospital information system (HIS) and other
information systems in the health sector that use the electronic medical
record to exchange patient data in a standardized format. EasyOne Connect
and EasyOne Pro/LAB have EMR plug-ins preinstalled:
• HL7 – Health Level 7 is an international EMR standard.
• GDT – Gerätedatentransfer is a German EMR standard.
• XML file exchange – With this plug-in, you can connect your EMR system
using a simple and configurable XML file exchange.
 Operator’s Manual of your EMR system

6.2.2 About possible workflows with your EMR system

There are two general possibilities for working with your EMR system: the
order workflow and the direct-start workflow.

The order workflow

For the order workflow, EasyOne Connect or EasyOne Pro/LAB and your EMR
system are connected over the network and exchange so-called orders.
In an additional menu on the main menu, EasyOne Connect and
EasyOne Pro/LAB display the orders from your EMR system. With the order
workflow, you initiate a spirometry test in EasyOne Connect or on
EasyOne Pro/LAB.
You can also send test results to your EMR system manually even if these test
results have not been ordered from your EMR system.

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Connectivity and data exchange

The direct-start workflow

Your EMR system is either connected to EasyOne Connect or EasyOne Pro/LAB
over the network, or your EMR system is installed on the same PC as
EasyOne Connect.
Either way, your EMR system can interact and launch EasyOne Connect or
EasyOne Pro/LAB directly. EasyOne Connect or EasyOne Pro/LAB act as an
external device to your EMR system.
This workflow is called direct-start workflow because you initiate a spirometry
test from your EMR system.
 Sending individual test results to your EMR system, 51

6.2.3 About using EasyOne Air to process orders

When you synchronize EasyOne Air with EasyOne Connect, orders from your
EMR system are also synchronized with EasyOne Air.
On EasyOne Air, you can select orders from your EMR system in the orders
menu.

6.2.4 Overview of the integration process

Please contact the ndd Servicing Department to start an integration project.

The integration process consists of the following steps:
1 Defining an interface based on clinical requirements, IT requirements, and
security requirements
2 Implementing a configuration in close cooperation with your staff
3 Verifying the implemented configuration
NOTICE
CONNECTION FAILURE
Updates to the EMR system can potentially influence the connection.
When you update the EMR system, you must check the correctness of the
transferred data to connected systems.

 Operator’s Manual of your EMR system

SDK – ndd EMR plug-in Software Developer Guide
Contact information, 4

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Connectivity and data exchange

6.2.5 Overview of the plug-ins for EMR systems

Utilities > Configuration > EMR

6.2.5.1 About the HL7 plug-in

The HL7 plug-in allows you to work with orders, which you can process as you
choose. This workflow is the order workflow.
Alternatively, you can use the direct-start workflow and initiate spirometry
from your EMR system.

Supported Features
EasyOne Connect and EasyOne Pro/LAB support the following features of HL7:
• Receiving patient demographics from your EMR system
• Sending test results to your EMR system
• Working with orders
• File-based message exchange
• Message acknowledgments
• Sending discrete data
• Sending reports
 Application Note EasyConnect: HL7 Connector
Application Notes for further information, 3
Operator’s Manual of your EMR system
Processing orders from your EMR system, 49
Sending individual test results to your EMR system, 51

6.2.5.2 About the GDT plug-in

With the GDT plug-in, you can only use the direct-start workflow and initiate
spirometry from your EMR system. The order workflow is not supported.

Supported Features
EasyOne Connect and EasyOne Pro/LAB support the following features of GDT:
• Receiving patient demographics from your EMR system
• Sending test results to your EMR system
• File-based message exchange
• Sending discrete data
• Sending reports
 Operator’s Manual of your EMR system
Initiating a spirometry test with the direct-start workflow, 50
Sending individual test results to your EMR system, 51
Type, 114

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Connectivity and data exchange

6.2.5.3 About the XML file exchange plug-in

The XML file exchange plug-in is a simple interfacing tool that allows you to
connect to your EMR system with a simple custom configuration.
The XML plug-in supports the order workflow and the direct-start workflow.

Supported Features
EasyOne Connect and EasyOne Pro/LAB support the following features:
• Receiving patient demographics from your EMR system
• Sending test results to your EMR system
• Working with orders
• File-based message exchange
• Sending discrete data
• Sending reports
 Software Developer Guide SDK – ndd EMR plug-in

6.2.5.4 About custom plug-ins

ndd offers a software development kit that enables third parties and
customers to develop customized EMR plug-ins to interface with any EMR
system.
 Software Developer Guide SDK – ndd EMR plug-in

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Connectivity and data exchange

6.2.6 Working with your EMR system

6.2.6.1 Processing orders from your EMR system

If you have interfaced your EMR system with EasyOne Connect or EasyOne Pro/
LAB through the HL7 plug-in or a custom EMR plug-in, you can access the
patient data of your EMR system in the orders menu in EasyOne Connect or on
EasyOne Pro/LAB. On the main menu, the additional Orders button is
displayed. This procedure represents the order workflow.
Prerequisite
 You have configured the HL7 plug-in, the XML plug-in, or a custom
EMR plug-in.
About the HL7 plug-in, 47
About the XML file exchange plug-in, 48
About custom plug-ins, 48

 Additional orders button in the main menu

In the orders menu, you process the orders. The orders menu is similar to the
patients menu. However, you cannot edit patient data in the orders menu.
1 Choose Orders.
2 Select an order with the status Pending.
3 Choose Test.
4 Perform spirometry with the patient.
5 To view a completed order, choose View.
6 To delete an order, choose Delete.
7 Repeat steps 2 to 5 until you have completed all pending orders.
8 Choose Close.
 All results are transmitted to your EMR system.
 Overview of the user interface of EasyOne Connect, 34

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Connectivity and data exchange

6.2.6.2 Initiating a spirometry test with the direct-start workflow

With the direct-start workflow, you initiate spirometry from your EMR system.
All plug-ins support this workflow.
Prerequisite
 You have configured any one of the available plug-ins.
About the HL7 plug-in, 47
About the GDT plug-in, 47
About the XML file exchange plug-in, 48
About custom plug-ins, 48
1 Launch your EMR system.
2 Choose the external devices menu.
3 Select either EasyOne Connect or EasyOne Pro/LAB and confirm.
 EasyOne Connect is launched automatically.
 In EasyOne Connect or on EasyOne Pro/LAB, the screen for entering
patient data is displayed.
4 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
Fill out those fields that are marked with an asterisk (*).
 You cannot complete adding patient data without filling out these
fields.
5 In all other fields, enter additional patient data if necessary.
6 Choose OK.
7 Choose the desired test and confirm.
8 Perform spirometry with the patient.
9 If required, print an additional report from the test result screen.
10 Choose Finish.
 The test results are sent to your EMR system, and EasyOne Connect is
closed automatically.
 Your EMR system receives the test results.
11 In your EMR system, confirm the received test results and proceed as
required.
 Performing spirometry, 52

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Connectivity and data exchange

6.2.6.3 Sending individual test results to your EMR system

It is possible to send individual test results to your EMR system even if that
test is not part of an order from the EMR system. This enables you to work
without orders from your EMR system and to only send test results to your EMR
system.
Prerequisite
 You have configured any one of the available plug-ins.
About the HL7 plug-in, 47
About the GDT plug-in, 47
About the XML file exchange plug-in, 48
About custom plug-ins, 48
1 Choose Patients.
2 Select a patient.
3 Choose History.
4 Choose the button.
 Hidden buttons are revealed.
5 Choose Send to EMR.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7 Performing spirometry

7.1 Overview of the spirometry workflow

Performing spirometry

Ö
7.2 Instruct the patient

Ö
7.5.1 Choose a test Ö
7.5.2

Add a new patient Select existing patient

Enter patient data No Previous test performed

within 24 h?

Yes

Add trial, add post, or create new test

Ö
7.5.3 Summary screen is displayed

Ö
7.5.4 Prepare EasyOne Flow Tube

Set baseline

Patient performs breathing maneuver

Repeat trial
No
Quality message OK?

Yes
Add trial
No
3 successful trials completed?

Yes

End test

Dispose of EasyOne Flow Tube

Print report

 General spirometry workflow using EasyOne Air stand-alone

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7.2 About preparation of spirometry and instructions for the patient

Preparing the patient

Prepare the patient for testing: The patient should loosen tight clothing,
remove dentures, and relax. The patient may sit or stand. If the patient is
standing, perform testing in an area free of sharp table edges or counter
edges, or have a chair available as there is a slight possibility that the patient
faints during the strenuous breathing maneuver of the spirometry test.

Explaining spirometry
Explain that the purpose of the test is to determine how much air a person’s
lungs can hold and how quickly that air can be expelled with a forceful,
maximum effort. Since the spirometry test requires active participation on the
part of the patient, it is very important to demonstrate the breathing
maneuver to the patient.
The most commonly used spirometry test is the FVC test. Emphasize the
essential elements of the breathing maneuver, for example, for the FVC test:
• Filling lungs completely
• Sealing lips around the EasyOne Flow Tube so that there are no leaks,
taking care not to block its opening with the teeth or tongue and not to
bite down excessively
• Blasting out as hard and fast as possible
• Blowing out continuously until the lungs are completely empty

Different breathing maneuvers for different tests

This chapter describes the overall process of performing spirometry with the
FVC test as an example. The different spirometry tests differ only in the
breathing maneuver that the patient has to perform. The overall process of
performing spirometry is the same.
Therefore, to perform the other spirometry tests, familiarize yourself with the
other breathing maneuvers.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Carefully watch the patient

It is your responsibility to watch the patient for signs of distress. After several
trials, let the patient take a break. If it is not possible to obtain an adequate
number of good trials, even after repeated attempts, you should let the
patient rest, depending on how the patient feels, or stop the measurement
entirely. After a break, you can still pick up a test and add trials, or print the
report.

Practice by testing yourself and others

If you are new to spirometry, practice by testing yourself and colleagues prior
to testing patients. You will learn to recognize a poor effort by observing the
patient and/or interpreting the quality messages displayed by EasyOne Air
after each trial. After a poor trial, you must explain what went wrong. Develop
enthusiastic coaching techniques to use during the breathing maneuver to
maximize your chances of getting quality results with a minimum number of
trials.

Animation program for children

If you use EasyOne Connect in combination with EasyOne Air, an animation
program for children is available. The animation is available for the FVC test,
the FVL test and the SVC test. You can choose between three animations:
balloon, cake, and monkey.
When the animation program is activated, the manufacturer recommends
disabling the manual test stop and working with the automatic test stop. You
can configure manual or automatic test stop under Utilities > Configuration
> Test > General > Test Procedure.
 Breathing maneuvers for all available tests, 76
Avoiding contamination while performing spirometry, 81
Test Procedure, 108

7.3 About quality messages for trials and quality grades for tests

Quality messages
To obtain reliable results, an acceptable quality of the trials is necessary. The
quality of a trial depends on cooperation of the patient and this, in turn,
depends on the quality of your instructions. To facilitate giving good
instructions to the patient, an automatic quality control function displays
feedback prompts. After each trial, a message on the screen informs you
whether the trial is acceptable or not. If the trial is not acceptable, the
message will guide you on how to coach the patient to do better.
When you see the Test complete message, you do not need to conduct further
trials.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Quality grades
A quality grading from A to F is displayed at the end of the test. It provides
information on the overall quality of the test. You should keep performing
trials with the patient until the quality grade is an A or a B. Only after several
trials, when the patient is exhausted and if the patient has already had a
break, a quality grade C is sufficient.
 List of quality messages and quality grades, 72

7.4 About posts and bronchodilation

A test and a post are performed together to determine the response to

bronchodilating asthma medication.
After performing an FVC test or an FVL test, the patient is treated with a
bronchodilator. Approximately 10 to 20 minutes after the medication, when
the bronchodilator shows effect, the test is repeated as a post. The results of
the previous test and the post are then compared on the result screen and on
the test protocol. Posts can only be added to an existing test within 24 hours.

7.5 Performing spirometry using EasyOne Air stand-alone

7.5.1 Choosing a test and adding a new patient

If you wish to register the patient to be tested immediately before conducting

the test, you can start by manually adding a new patient.
1 If you want to perform an FVC test, choose .
 The patient selection list is displayed.
2 If you want to perform any other test, do the following:
a) Choose ? .
b) Choose one of the test icons.
3 Select <Add Patient>.
 A dialog is displayed.
 The dialog consists of several steps.
4 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
In each step, enter the requested data and choose Next >.
5 In the last step, choose Finish.
 The summary screen is displayed.
 About the summary screen, 57
Performing a complete test using EasyOne Air stand-alone, 58

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7.5.2 Choosing a test and selecting an existing patient

If you test a patient that you have tested before or if you have transferred
patient data onto EasyOne Air from EasyOne Connect on your PC, start by
selecting an existing patient.
Prerequisites
 Previously, you have manually added the patient to EasyOne Air.
 Or, you have transfered patient data onto EasyOne Air from
EasyOne Connect on your PC.
Working with patient data and reports on EasyOne Air, 83
Copying patient data between EasyOne Air and EasyOne Connect, 89
1 If you want to perform an FVC test, choose .
 The patient selection list is displayed.
2 If you want to perform any other test, do the following:
a) Choose ? .
b) Choose one of the test icons.
 The patient selection list is displayed.
3 Select a patient.
 If the patient has performed a test within the previous 24 hours, the
question window is displayed. Proceed with step 4.
 If the patient has not performed a test before or not within the previous
24 hours, the summary screen is displayed. Step 4 does not apply.
4 If the question window is displayed, do one of the following:
a) To add a trial to the existing test, choose Add Trial.
b) To add a post to the existing test after adminstering a bronchodilator,
choose Add Post.
c) To create a new test that is unrelated to the existing test, choose Create
new.
 The summary screen is displayed.
 About the summary screen, 57
Performing a complete test using EasyOne Air stand-alone, 58

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7.5.3 About the summary screen

The summary screen displays common data about the patient, that you have
entered before.
You can edit the data and for example, add the following medical data about
the patient:
• Asthma status
• Dyspnea status
• Smoker status
• Cigarettes per day
• Smoke years
• Profession
• Occupation exposure
• Diagnosis
In addition, you can access reports of previous tests of the patient.
 Performing a complete test using EasyOne Air stand-alone, 58

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7.5.4 Performing a complete test using EasyOne Air stand-alone

Required materials
• A new EasyOne Flow Tube for each patient
• For an FVL test, an MVV test, or an SVC test, a nose clip is required.
Prerequisites
 For the FVL test, the MVV test, and the SVC test, you have entered the
environment temperature within 1°C or 1.8°F accuracy.
 You have chosen a test and added a new patient.
 Or you have chosen a test and selected an existing patient.
 The summary screen is displayed.
 You are wearing disposable gloves.
 You have instructed the patient on how to perform the test before you
start with the test.
Choosing a test and adding a new patient, 55
Choosing a test and selecting an existing patient, 56
About preparation of spirometry and instructions for the patient, 53
WARNING
PATIENT CROSS-CONTAMINATION
If you reuse the EasyOne Flow Tube, contamination from an infected patient
can be deposited on the EasyOne Flow Tube. The contamination from an in-
fected patient can later be passed on to the next patient who is tested.
You cannot clean or disinfect the EasyOne Flow Tube in any way. The
EasyOne Flow Tube is for single-patient use only.
Always replace the EasyOne Flow Tube with a new one between patients or
when performing spirometry on yourself.
Only use an original EasyOne Flow Tube by the manufacturer.

PATIENT HEALTH HAZARD

Performing spirometry can cause an asthma attack or bronchospasm.
If the patient is on medication, check the contraindications for the medica-
tion.

CAUTION
PATIENT HEALTH HAZARD
Pulmonary function tests require maximum effort on the part of the patient and
may lead to dizziness.
Make sure the patient cannot be injured by objects in the vicinity if the patient
falls.
Watch the patient for signs of dizziness and support the patient if necessary.
Do not leave the patient unattended during a test.

The EasyOne Flow Tube is a single-patient-use disposable and hygienically

packaged. Visually check the wrapper of a new EasyOne Flow Tube for defects.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

If the wrapper of the EasyOne Flow Tube has a defect, discard the
EasyOne Flow Tube, take another EasyOne Flow Tube, and visually check the
wrapper of the new EasyOne Flow Tube again for defects.
Visually check the EasyOne Flow Tube for defects before use and between
trials.
Before you use EasyOne Air with the patient, make sure that there are no
obvious or wet residues on EasyOne Air from prior cleaning.

 To prepare the test

1 Partly unwrap the EasyOne Flow Tube.
 For hygiene reasons, grip the partly unwrapped EasyOne Flow Tube only
with the wrapper at the mouthpiece. Do not touch the EasyOne Flow Tube.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

2 Fully insert the EasyOne Flow Tube into the EasyOne Flow Tube holder as
depicted below, but keep the partly unwrapped wrapper on the mouthpiece
of the EasyOne Flow Tube.
 The shape of the EasyOne Flow Tube and the EasyOne Flow Tube holder
guide the orientation of the EasyOne Flow Tube. You can only insert the
EasyOne Flow Tube fully if it is positioned correctly.
 When you insert the EasyOne Flow Tube, avoid direct sunlight as it can
interfere with the automatic recognition of the EasyOne Flow Tube.

3 Choose Start test.

 The sensor starts buzzing and the user action required window is
displayed for setting the baseline.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4 To set the baseline, seal off one end of the EasyOne Flow Tube with the
wrapper to avoid air flow.

5 Choose OK.
 The Please wait… message is displayed while the baseline is set.
 After the baseline has been set, a signal sounds, and the BLAST OUT…
message is displayed.
6 Remove the wrapper from the EasyOne Flow Tube.
7 If you want to perform an FVL test, an MVV test, or an SVC test, attach the
nose clip to the patient’s nose.
8 Hand EasyOne Air to the patient.
9 Tell the patient to breathe at rest.
 The following procedure To perform the FVC breathing maneuver
represents the breathing maneuver for the FVC test as an example. If you
want to perform any other test, replace the procedure To perform the FVC
breathing maneuver with the breathing maneuver for the required test.
Breathing maneuvers for all available tests, 76

 To perform the FVC breathing maneuver

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3 Tell the patient to exhale as hard and as fast as possible and to continue
blowing out until the lungs are completely empty.
 While the patient performs the breathing maneuver, a feedback sound
indicates the effort of the patient. The harder the patient exhales, the faster
the feedback sound is repeated. When the patient exhales more slowly
towards the end, the feedback sound also gets slower.
 At the end of the trial, another feedback sound indicates whether the
trial is acceptable or not.
4 Tell the patient to take the EasyOne Flow Tube out of the mouth and to
breathe normally again.
 If the trial is acceptable, the green quality message is displayed.
 If the trial is not acceptable, a yellow or red quality message is
displayed suggesting how to improve the breathing maneuver.

 To add trials
1 If you want to look at the details of this trial, choose Data.
 The report screen is displayed.
2 Choose Next.
3 Repeat the previous procedure To perform the FVC breathing maneuver
and this procedure To add trials until a green acceptability message is
displayed.
 After the third and every following trial, a red or a green acceptability
message is displayed with the quality grade for the test.
 After three acceptable trials, the test ends automatically and a green
acceptability message is displayed.
4 Choose Data.
 The report screen is displayed.
5 Choose End session.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

 To end the test

1 To remove the EasyOne Flow Tube, do the following:
a) Grip EasyOne Air with both hands, with the backside of EasyOne Air
facing towards you and with the EasyOne Flow Tube pointing up.
b) Press against the protruding lip of the EasyOne Flow Tube with both
thumbs and push the EasyOne Flow Tube out.
c) Do not touch the EasyOne Flow Tube anywhere else than at the
protruding lip.
d) Drop the EasyOne Flow Tube directly into a waste container.

2 WARNING! Patient cross-contamination and infection of the technician:

Always wear disposable gloves. Between patients, always exchange
disposable gloves, clean EasyOne Air, and disinfect hands. / Electric
shock, failure of EasyOne Air, and false diagnosis: Make sure that no fluid
penetrates the EasyOne Flow Tube holder or the inside of EasyOne Air while
cleaning. To clean EasyOne Air, do not fully dip EasyOne Air into any fluid.
To clean EasyOne Air and to disinfect your hands after each patient, do the
following:
a) Use a soft cloth with a cleaning solution according to the List of
cleaning solutions for EasyOne Air, 82 and wipe the handles and the
display of EasyOne Air.
b) Put down EasyOne Air.
c) Take off or change the disposable gloves and disinfect your hands
before you put on new disposable gloves.
3 If you want to print the report immediately, choose Print.
 A progress bar is displayed that indicates the progress of the print-out.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4 Choose End.
 The home screen is displayed.
 List of cleaning solutions for EasyOne Air, 82
About interpreting results, 71
About compatible printers, 19

7.6 Performing spirometry using EasyOne Connect in combination

with EasyOne Air

7.6.1 Connecting EasyOne Air to EasyOne Connect

To use EasyOne Connect in combination with EasyOne Air, you need to

connect EasyOne Air to your PC over Bluetooth.
Prerequisite
 On your PC, Bluetooth is enabled.
A USB Bluetooth adapter is supplied with EasyOne Air in case your PC
does not have Bluetooth built-in.
List of box contents, 17
If EasyOne Air is directly connected to a PC over USB, performing tests is not
possible. Leakage currents could harm the patient. Connect EasyOne Air to
your PC wirelessly, only.
1 On EasyOne Air, choose > > .
2 Select the Bluetooth check box and keep the menu open.
 EasyOne Air is discoverable over Bluetooth by other devices.
3 On your PC, navigate to the Bluetooth menu to add Bluetooth devices.
 Where to find the Bluetooth menu varies between the versions of
Microsoft Windows. For assistance, open the Control Panel in any Windows
version and press the F1 key.
 In the list of available devices, you see “EasyOne Air” followed by its
serial number.
4 On your PC, select EasyOne Air for pairing.
5 Exchange the Bluetooth pairing key as advised by your PC and by
EasyOne Air.
 Your PC and EasyOne Air are now paired. Whenever Bluetooth is
enabled on both devices and both devices are within range, your PC and
EasyOne Air reconnect automatically.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7.6.2 Performing a complete test using EasyOne Connect together with EasyOne Air

Required materials
 A new EasyOne Flow Tube for each patient
 For an FVL test, an MVV test, or an SVC test, a nose clip is required.
Prerequisites
 You have connected EasyOne Air to EasyOne Connect.
 You have added the patient data to the database of EasyOne Connect.
 Or the patient data is already in the database of EasyOne Connect.
 You are wearing disposable gloves.
 You have instructed the patient on how to perform the test before you
start with the test.
Connecting EasyOne Air to EasyOne Connect, 64
Adding patient data to the database of EasyOne Connect, 87
About preparation of spirometry and instructions for the patient, 53

WARNING
PATIENT CROSS-CONTAMINATION
If you reuse the EasyOne Flow Tube, contamination from an infected patient
can be deposited on the EasyOne Flow Tube. The contamination from an in-
fected patient can later be passed on to the next patient who is tested.
You cannot clean or disinfect the EasyOne Flow Tube in any way. The
EasyOne Flow Tube is for single-patient use only.
Always replace the EasyOne Flow Tube with a new one between patients or
when performing spirometry on yourself.
Only use an original EasyOne Flow Tube by the manufacturer.

PATIENT HEALTH HAZARD

Performing spirometry can cause an asthma attack or bronchospasm.
If the patient is on medication, check the contraindications for the medica-
tion.

The EasyOne Flow Tube is a single-patient-use disposable and hygienically

packaged. Visually check the wrapper of a new EasyOne Flow Tube for defects.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

 To prepare the test

1 Partly unwrap the EasyOne Flow Tube.
 For hygiene reasons, grip the partly unwrapped EasyOne Flow Tube only
with the wrapper at the mouthpiece. Do not touch the EasyOne Flow Tube.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3 On the main menu of EasyOne Connect, choose Patients.

4 Select the patient that you want to test.
5 At the bottom of the screen, choose Test.
6 Choose the test that you want to perform.
7 If the environment conditions screen is displayed, enter the current values
and choose Confirm >>.
 For the FVL test, the MVV test, and the SVC test, you must enter the
environment temperature within 1°C or 1.8°F accuracy.
 If the patient has already performed a test on the same day, a selection
window is displayed. Proceed with step 8.
 If the patient has not performed a test on the same day, the screen of
the selected test is displayed with a pop-up window that asks you to block
the EasyOne Flow Tube. Proceed with step 9.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

8 If the selection window is displayed, do one of the following:

a) To add a trial to the existing test, choose Add Trial.
b) To add a post to the existing test after administering a bronchodilator,
choose Add Post.
c) To create a new test that is unrelated to the existing test, choose Test.
 The screen of the selected test is displayed with a pop-up window that
asks you to block the EasyOne Flow Tube.
9 To set the baseline, seal off one end of the EasyOne Flow Tube with the
wrapper to avoid air flow.

10 Choose OK.
 In the colored status bar, Setting baseline: Avoid flow! is displayed.
 After the baseline has been set, Start test … is displayed.
11 Remove the wrapper from the EasyOne Flow Tube.
12 If you want to perform an FVL test, an MVV test, or an SVC test, attach the
nose clip to the patient’s nose.
13 Hand EasyOne Air to the patient.
14 Tell the patient to breathe at rest.
 The following procedure To perform the FVC breathing maneuver
represents the breathing maneuver for the FVC test as an example. If you
want to perform any other test, replace the procedure To perform the FVC
breathing maneuver with the breathing maneuver for the required test.
Breathing maneuvers for all available tests, 76

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

 To perform the FVC breathing maneuver

1 Tell the patient to fill the lungs completely.
2 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal
the lips around the EasyOne Flow Tube.
 The patient must not block the opening with the tongue or teeth or bite
down excessively on the EasyOne Flow Tube.
3 Tell the patient to exhale as hard and as fast as possible and to continue
blowing out until the lungs are completely empty.
4 When the message Manually End Test is displayed, you can choose the
Button End Test at your discretion.
 You can configure manual test stop or automatic test stop under
Utilities > Configuration > Test > General > Test Procedure.
 The test result is displayed.
5 Tell the patient to take the EasyOne Flow Tube out of the mouth and to
breathe normally again.
 If the trial is acceptable, the green quality message is displayed.
 If the trial is not acceptable, a yellow or red quality message is
displayed suggesting how to improve the breathing maneuver.

 To add trials
1 Choose Add Trial.
2 Repeat the previous procedure To perform the FVC breathing maneuver
and this procedure To add trials until the green Session Complete!
message is displayed.
 In the Test Information area the quality grade for the test is displayed.
3 Do the following:
a) Review the test quality that is displayed in the Test Information area.
b) Decide whether the test quality is sufficient or not.
c) If necessary, add a trial and repeat the previous procedure To perform
the FVC breathing maneuver.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

 To end the test

2 WARNING! Patient cross-contamination and infection of the technician:

Always wear disposable gloves. Between patients, always exchange
disposable gloves, clean EasyOne Air, and disinfect hands. / Electric
shock, failure of EasyOne Air, and false diagnosis: Make sure that no fluid
penetrates the EasyOne Flow Tube holder or the inside of EasyOne Air while
cleaning. To clean EasyOne Air, do not fully dip EasyOne Air into any fluid.
To clean EasyOne Air and to disinfect your hands after each patient, do the
following:
a) Use a soft cloth with a cleaning solution according to the List of
cleaning solutions for EasyOne Air, 82 and wipe the handles and the
display of EasyOne Air.
b) Put down EasyOne Air.
c) Take off or change the disposable gloves and disinfect your hands
before you put on new disposable gloves.
3 To print the report immediately, choose Print from the bottom right of the
screen.
 The report is generated and sent to the configured printer.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

4 To preview the report, do the following:

a) Choose Report from the bottom right of the screen.
b) To print the report on the printer that you have configured, choose Print
from the top of the screen.
c) To export the report as a PDF file or to select a different printer, choose
Print Menu from the top of the screen.
d) To return to the test result screen, choose Return from the menu bar.
5 To return to the main menu, choose Main Menu from the menu bar.
 List of cleaning solutions for EasyOne Air, 82
About interpreting results, 71
Description of printer configurations of EasyOne Connect, 117

7.7 About interpreting results

The quality grades A to C indicate a reliable result. The quality grades D and F
indicate insufficient test quality. The result must then be interpreted with
caution.
On the printed report, parameters that are below the lower limit of normal
(LLN) are marked with an asterisk (*). Unacceptable trials are marked with the
number sign (#). In addition to the marks, EasyOne Air and EasyOne Connect
offer an automatic interpretation aid.
It is possible to deactivate the automatic quality grading function and the
system interpretation function.
 List of tests and parameters, 36
List of quality messages and quality grades, 72
Configuration, 94

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7.8 List of quality messages and quality grades

7.8.1 About quality messages and quality grades

End-of-Test criteria, quality criteria, and quality grading are based upon the
published standards [1], [4], [13], [14].
Quality grading is based on the sources [4], [13], [14].
The main articles [2] and [3] do not numerically define the minimum
expiratory peak flow time (PEFT) that is required for an acceptable test. For
EasyOne Air, 160 ms is used.
 List of bibliographic references, 132

7.8.2 List of quality messages for trials

Immediately after a trial, quality messages help you to give feedback to the
patient whether the trial has been acceptable or not. If the trial has not been
acceptable, a recommendation on how to improve is displayed.

Displaying quality messages for trials

To display the quality message for a trial, choose the trial rank from the
parameter table on the result screen (Patients > select patient > History
> select test). The trial ranks are given in numbers 1, 2, 3, etc. and may be
crossed out.

Content of quality messages

Quality messages can contain warnings or errors. For example, the quality
messages can provide feedback to the patient as to how to improve the
breathing maneuver or can give you advice about what to do with
EasyOne Air.
The following icons indicate who or what is affected.

✓ No action is required.
The problem can be resolved by the patient.

The problem can be resolved by checking EasyOne Air.

The following table gives an overview of potential quality messages.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Code Affecting Test type Description

00 ✓ All No error or warning, test is OK.
01 FVC, FVL Abrupt end of test detected.
Patient may not have exhaled completely.
Detailed criteria:
Expiration time was less than 2 seconds,
OR volume during last 0.5 seconds >40 mL when expiration time is <6 seconds,
OR volume during last second >25 mL when test ended by an inspiration.
The patient must exhale longer and force as much air as possible out of his or her
lungs.
02 FVC, FVL Patient hesitation detected.
Patient hesitation detected.
Detailed criteria:
Back-extrapolated volume greater than 150 mL,
OR 5% of FVC whichever is greater (for age ≤6: 80 mL or 12.5% of FVC, whichever is
greater).
The patient must blast out as quickly and as hard as possible.
SSA Patient hesitation detected.
Patient hesitation detected.
Detailed criteria:
Back-extrapolated volume greater than 100 mL,
OR 5% of FVC whichever is greater (for all ages).
The patient must blast out as quickly and as hard as possible.
03 FVC, FVL Please, blow out faster.
Peak flow is delayed.
Detailed criteria: Time until peak flow greater than 160 ms.
The patient must blast out as quickly and as hard as possible.
04 FVC, FVL Please, blow out longer.
Patient may not have exhaled completely.
Detailed criteria:
Expiration time less than 2 seconds,
OR volume in the last 0.5 seconds of the expiration more than 100 mL.
The patient must exhale longer and force as much air as possible out of his or her
lungs.
05 FVC, FVL Unable to detect forced maneuver.
Software was unable to detect a forced maneuver.
Please retry maneuver and follow the instructions that are shown during the
maneuver.
06 SVC Unable to detect steady tidal breathing.
The software was unable to detect steady tidal breathing.
Detailed criteria:
All end-inspiratory volumes of 3 breaths are not within 200 mL,
AND/OR the difference in VT of 3 breaths is larger than 200 mL.
Instruct the patient to breathe steadily during tidal breathing phase.
07 SVC Incomplete maneuver, unable to calculate IRV.
Unable to detect complete maneuver and to calculate IRV.
Retry maneuver and follow the instructions that are shown during the maneuver.
Complete inspiration and expiration are required.
 Quality messages for trials

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Code Affecting Test type Description

08 SVC Incomplete maneuver, unable to calculate ERV.
Unable to detect complete maneuver and to calculate ERV.
Retry maneuver and follow the instructions that are shown during the maneuver.
Complete inspiration and expiration are required.
09 FVC, FVL Test started too early.
Early test start detected.
Detailed criteria:
The time to peak flow (PEFT) is less than 30 ms,
OR flow detected before test was started.
Instruct the patient to wait until the baseline setting is finished and until the
software signals to start the test.
10 FVC, FVL Cough detected.
A cough has been detected.
Instruct the patient to avoid coughing during the measurement.
14 Calibration Calibration result out of range – Check setup.
Check Calibration result is out of range.
Detailed criteria: The measured volume is out of ±3.5% of the target value.
Check the test setup and repeat the test. If error reappears, contact service.
15 Calibration Try again – Flow criteria not met!
Check Cal-syringe flow rate too fast or too slow.
Perform the calibration check with the appropriate flow speed.
16 Calibration Inspiratory or expiratory maneuver not detected.
Check Either only an inspiratory or only an expiratory maneuver detected.
Perform complete inspiratory and expiratory maneuvers and follow the given
instructions.
46 All Timeout identified.
A timeout has occurred during the maneuver.
Follow all test instructions.
47 All Device error.
An unexpected device error occurred.
Check if sensor is connected correctly and repeat trial.
48 All Invalid trial, please repeat trial.
Trial did not meet acceptability criteria.
Repeat trial.
50 ✓ All No error or warning, test is OK.
51 All Error (51): Test started too early.
Early-start detected.
Wait until the instrument signals to start the test.
52 FVC, FVL Error (52): Unable to detect maneuver.
Unable to detect maneuver.
Retry maneuver and follow the instructions that are shown during the maneuver.
99 All Error: Invalid trial.
 Quality messages for trials

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

7.8.3 List of quality grades for tests

Quality grades help you as the operator to assess the quality of a completed
test.

Quality grades for the FVC test, the FVL test, and the OSHA test

Rating Criteria
A At least 3 acceptable trials (for age 6 and under: 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 and under: 80 mL or 8% of FVC
or FEV1 whichever is greater)
B At least 3 acceptable trials (for age 6 and under: 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 and under: 100 mL or 10% of
FVC or FEV1 whichever is greater)
C At least 2 acceptable trials 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 and under: 150 mL or 15% of FVC or FEV1 whichever is greater)
D (1) At least 2 acceptable trials but the results are not reproducible according to 'C'.
Quality message: Result not reproducible
D (2) Only one acceptable trial
Quality message: Only one acceptable trial
F No acceptable trial available
 Quality grades for the FVC test, the FVL test, and the OSHA test

Quality grades for the SSA test

Rating Criteria
A At least 3 acceptable trials AND the difference between the best two FEV1 and FVC values is equal to or less
than 100 mL
B At least 3 acceptable trials AND the difference between the best two FEV1 and FVC values is equal to or less
than 100 mL or 5% of FVC or FEV1, respectively.
F No acceptable trial available
 Quality grades for the FVC test, the FVL test, and the OSHA test

Quality grades for the SVC test

Rating Criteria
A At least 3 acceptable trials AND the difference between the best VC values is equal to or less than 150 mL.
B At least 2 acceptable trials 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
 Quality grades for the SVC test

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Breathing maneuvers for all available tests

8 Breathing maneuvers for all available tests

8.1 About breathing maneuvers for all available tests

The overall process of performing spirometry is the same for all spirometry
tests. The tests differ in the breathing maneuver that the patient must
perform.
 Performing spirometry, 52

8.2 Performing the breathing maneuver for the FVC test

The forced expiratory vital capacity test is the most commonly used
spirometry test. During the breathing maneuver, the patient must exhale with
a forceful, maximum effort.
1 Tell the patient to breathe at rest.
2 Tell the patient to fill the lungs completely.
3 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal
the lips around the EasyOne Flow Tube.
 The patient must not block the opening with the tongue or teeth or bite
down excessively on the EasyOne Flow Tube.
4 Tell the patient to exhale as hard and as fast as possible and to continue
blowing out until the lungs are completely empty.
5 Tell the patient to take the EasyOne Flow Tube out of the mouth and to
breathe normally again.
 If the trial is acceptable, the green quality message is displayed.
 If the trial is not acceptable, a yellow or red quality message is
displayed suggesting how to improve the breathing maneuver.
 Performing spirometry, 52

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Breathing maneuvers for all available tests

8.3 Performing the breathing maneuver for the FVL test

With the flow volume loop test, a deep inhalation directly follows the
exhalation maneuver.
Required material
 A nose clip
Prerequisite
 For this test, you must enter the environment temperature within 1°C or
1.8°F accuracy.
1 Tell the patient to breathe at rest.
2 Tell the patient to fill the lungs completely.
3 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal
the lips around the EasyOne Flow Tube.
 The patient must not block the opening with the tongue or teeth or bite
down excessively on the EasyOne Flow Tube.
4 Tell the patient to exhale as hard and as fast as possible and to continue
blowing out until the lungs are completely empty.
5 Tell the patient to keep the EasyOne Flow Tube in the mouth, to breathe in,
and to continue inhaling until the lungs are completely filled again.
6 Tell the patient to take the EasyOne Flow Tube out of the mouth and to
breathe out again.
 If the trial has been acceptable, the green quality message is displayed.
 If the trial has not been acceptable, a yellow or red quality message is
displayed suggesting how to improve the breathing maneuver.
 Performing spirometry, 52

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Breathing maneuvers for all available tests

8.4 About the OSHA test

The OSHA test is intended for occupational testing and meets certain
standardization requirements. The OSHA test is only available with US
regional settings.
From the test menu in EasyOne Connect, choose the OSHA test.
On EasyOne Air, choose the OSHA test from the more menu.
The patient performs the same breathing maneuver as for the FVC test.
Reports meet the requirements of the following institutions and standards:
• Occupational Safety and Health Administration (OSHA)
• National Institute for Occupational Safety and Health (NIOSH)
• Cotton Dust standard (29 CFR: 1910.1043 Appendix D)
• Predicted values for adults according to Knudson (1976)
The default configuration for predicted values for adults is NHANES III. To use
predicted values for adults according to Knudson (1976), you need to change
the configuration in the following menu:
> > > Predicted set 1
According to these requirements, the reports contain the following
information:
• The best three tests and volume-time curves are saved and printed.
• The curves are printed in large, in validation size.
• There is no clinical interpretation displayed or printed.
 Performing spirometry, 52
Performing the breathing maneuver for the FVC test, 76
Application Note Reference Predicted Normal Values
Application Notes for further information, 3

8.5 About the SSA test

The SSA test is intended to test for social security disabilities. The SSA test is
only available with US regional settings.
The patient performs the same breathing maneuver as for the FVC test. Merely
the quality grades for the SSA are different from the quality grades for the FVC
test.
 Performing spirometry, 52
Performing the breathing maneuver for the FVC test, 76
Quality grades for the SSA test, 75

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Breathing maneuvers for all available tests

8.6 Performing the breathing maneuver for the MVV test

With the maximum voluntary ventilation test, the patient fully inhales and
fully exhales repeatedly.
Required material
 A nose clip
Prerequisite
 For this test, you must enter the environment temperature within 1°C or
1.8°F accuracy.
1 Tell the patient to breathe at rest.
2 Tell the patient to fully exhale.
3 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal
the lips around the EasyOne Flow Tube.
 The patient must not block the opening with the tongue or teeth or bite
down excessively on the EasyOne Flow Tube.
4 Tell the patient to fully inhale and fully exhale repeatedly for an
uninterrupted period of at least 12 seconds.
5 Tell the patient to take the EasyOne Flow Tube out of the mouth and to
breathe normally again.
 Performing spirometry, 52

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Breathing maneuvers for all available tests

8.7 Performing the breathing maneuver for the SVC test

The slow vital capacity test serves to determine the vital capacity and the lung
volumes. This test does not require great effort by the patient.
Required material
 A nose clip
Prerequisite
 For this test, you must enter the environment temperature within 1°C or
1.8°F accuracy.
1 Tell the patient to breathe at rest.
2 Tell the patient to take the EasyOne Flow Tube into the mouth and to seal
the lips around the EasyOne Flow Tube.
 The patient must not block the opening with the tongue or teeth or bite
down excessively on the EasyOne Flow Tube.
3 Tell the patient to continue breathing at rest.
 Typically, three to five breaths are required.
 Tidal Breathing is displayed.
4 When Start test … is displayed and when the steady-tidal acoustic signal
sounds, tell the patient to fully inhale and fully exhale.
 Instead, the patient can also fully exhale first and then fully inhale.
 The patient can take this deep breath slowly and does not need to force
it.
5 Tell the patient to take the EasyOne Flow Tube out of the mouth and to
breathe normally again.
 If the trial is acceptable, the green quality message is displayed.
 If the trial is not acceptable, a yellow or red quality message is
displayed suggesting how to improve the breathing maneuver.
 Performing spirometry, 52

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

9 Hygiene and cleaning

9.1 Avoiding contamination while performing spirometry

When handling the EasyOne Flow Tube, you must be careful not to
contaminate the next EasyOne Flow Tube or EasyOne Air.
The wrapped EasyOne Flow Tube is hygienically wrapped and for single-
patient use only. You must use a new EasyOne Flow Tube for each patient.

1 To protect yourself and to avoid infection of patients, wear disposable

gloves.
2 Never touch the EasyOne Flow Tube directly, but partly unwrap the wrapper
and grip the EasyOne Flow Tube with the wrapper still around the
mouthpiece.
3 Keep the wrapper while the patient is performing the breathing maneuver.
4 After the patient has completed the breathing maneuver, grip the
EasyOne Flow Tube with the wrapper again and dispose of the
EasyOne Flow Tube together with the wrapper.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

5 WARNING! Patient cross-contamination and infection of the technician:

Always wear disposable gloves. Between patients, always exchange
disposable gloves, clean EasyOne Air, and disinfect hands. / Electric
shock, failure of EasyOne Air, and false diagnosis: Make sure that no fluid
penetrates the EasyOne Flow Tube holder or the inside of EasyOne Air while
cleaning. To clean EasyOne Air, do not fully dip EasyOne Air into any fluid.
To clean EasyOne Air and to disinfect your hands after each patient, do the
following:
a) Use a soft cloth with a cleaning solution according to the List of
cleaning solutions for EasyOne Air, 82 and wipe the handles and the
display of EasyOne Air.
b) Put down EasyOne Air.
c) Take off or change the disposable gloves and disinfect your hands
before you put on new disposable gloves.
 Calibration check, 119
List of cleaning solutions for EasyOne Air, 82

9.2 List of cleaning solutions for EasyOne Air

Do not use just any cleaning solution for EasyOne Air. Only use the listed
cleaning solutions.

CAUTION
ELECTRIC SHOCK, FAILURE OF EASYONE AIR, AND FALSE DIAGNOSIS
Make sure that no fluid penetrates the inside of EasyOne Air while cleaning.
To clean EasyOne Air, do not immerse EasyOne Air in any fluid.

To clean EasyOne Air from environmental dirt, you can use a damp cloth.
After each patient, clean EasyOne Air. You can use a soft cloth with a cleaning
solution according to the following list.
The cradle may be cleansed with the same cleaning solution.
• 70 percent isopropyl alcohol solutions or
• Solutions that contain formaldehyde (only for use outside the USA) or
• Solutions that contain chlorine (e.g. Sani-Cloth Germicidal Disposable
Wipes, EPA Reg# 9480-4)

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Working with patient data and reports

10 Working with patient data and reports

CAUTION
FALSE DIAGNOSIS
The predicted values and the system interpretation are based on the patient
demographic data. Therefore, wrong patient data can cause false results.
Enter patient data meticulously.
Double-check that you have entered the patient data correctly.

10.1 Working with patient data and reports on EasyOne Air

10.1.1 Adding a patient to the database on EasyOne Air

>
1 Choose .
2 Choose .
 The add patient dialog is displayed.
3 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
In each step, enter the requested data and choose Next >.
4 In the last step, choose Finish.
 The summary screen is displayed.

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Working with patient data and reports

10.1.2 Editing patient data on EasyOne Air

>
1 Choose .
2 Choose .
 The patient selection list is displayed.
3 Select a patient.
 The summary screen is displayed.
4 Choose a list item.
5 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
Edit the entry and, if applicable, choose OK.
 Note that these changes only apply to sessions going forward and not
to previous sessions.
6 Choose OK.
7 Choose the home button.

10.1.3 Deleting a patient from the database on EasyOne Air

>
1 Choose .
2 Choose .
 The patient selection list is displayed.
3 Select a patient and confirm the message that is displayed.
 The selected patient data is deleted.

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Working with patient data and reports

10.1.4 Exporting data from EasyOne Air

>
You can export data including reports to the SD memory card.
Required material
 An SD card
1 Unlock and open the battery compartment by turning the lock screw
clockwise.

2 Insert the SD memory card into the SD card slot.

3 Close and lock the battery compartment by turning the lock screw
counterclockwise.

4 Choose > .

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Working with patient data and reports

5 Tap and hold on the patient record that you want to export.
 A pop-up window is displayed.
6 In the pop-up window, choose Export.
 The patient record is saved to the SD card.
7 Remove the SD card.

10.1.5 Viewing and printing reports on EasyOne Air

1 Choose .
 The test selection list is displayed.
2 Select a test.
 The report screen is displayed.
3 To skip through the trials, choose >> or <<.
4 To enlarge, tap on the combined volume-time curve and flow-volume curve
or on the parameter table.
5 To reduce, tap again on the combined volume-time curve and flow-volume
curve or on the parameter table.
6 If you want to print the report, choose Print.
 A progress bar is displayed, which indicates the progress of the print-
out.
7 To view another test, do the following:
a) Choose < Back.
b) From the test selection list, select another test.
 The report screen is displayed.
8 Choose the home button.
 The home screen is displayed.

10.1.6 About the reports menu and the history menu

To view the reports sorted by date, choose from the home screen.
To view the reports sorted by patient, choose > .
 Viewing and printing reports on EasyOne Air, 86

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Working with patient data and reports

10.2 Working with patient data and reports in EasyOne Connect

10.2.1 Adding patient data to the database of EasyOne Connect

1 Choose Patients.
2 Choose New.
3 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
Fill out those fields that are marked with an asterisk (*).
 You cannot complete adding patient data without filling out these
fields.
4 In all other fields, enter additional patient data if necessary.
5 Choose OK.

10.2.2 Editing patient data with EasyOne Connect

1 Choose Patients.
2 Select a patient.
3 Choose Edit.
4 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
Edit the fields that you want to change.
 You must fill out those fields that are marked with an asterisk (*).
5 In all other fields, enter additional patient data if necessary.
6 Choose OK.

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Working with patient data and reports

10.2.3 Merging two patient data records with EasyOne Connect

If, for example, two data records of the same patient were acquired with
different tests or if different spellings of a patient's name exist, you can
merge these two data records into one.
Prerequisite
 The two data records must have an identical date of birth.
1 Choose Patients.
2 Select one of the two data records.
3 Drag and drop that data record onto the second data record by doing the
following:
a) Right-click the first data record and keep the mouse button pressed.
b) Move the data record across the screen onto the second data record.
c) While the first data record is above the second, release the mouse
button.
 If the dates of birth of the two data records match, a confirmation
window is displayed.
 If the dates of birth of the two data records do not match, a warning is
displayed. In this case, you cannot merge these two data records.
4 To finish, confirm the message.

10.2.4 Deleting patient data from the database of EasyOne Connect

1 Choose Patients.
2 Select a patient.
3 Choose Delete.
 If user handling is not active, that is if you did not have to login to
EasyOne Connect, you are prompted for the default password. Proceed with
step 4.
 If user handling is active, that is if you did have to login to
EasyOne Connect, you are not prompted for a password. A confirmation
window is displayed immediately. Proceed with step 5.
4 Enter the default user name / password.
 The default user name / password is: admin / 8005
 A confirmation window is displayed.
5 Choose Yes.
 The patient and all corresponding tests are deleted from the database.
 About user handling and the default password of EasyOne Connect, 106

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Working with patient data and reports

10.2.5 Copying patient data between EasyOne Air and EasyOne Connect

Usually, you perform spirometry with EasyOne Air stand-alone. But it can be
more convenient to enter patient data, to evaluate results or to archive patient
data and results with EasyOne Connect on your PC. For this purpose, you can
create patient records in EasyOne Connect and copy patient records onto
EasyOne Air. After you have performed spirometry, you can copy patient data
and results from EasyOne Air to EasyOne Connect.

CAUTION
DATA LOSS
With the current firmware version V1.5.x, patient data and results cannot be
merged if the patient data and results exist both on EasyOne Air and in
EasyOne Connect. If any patient data for the same patient exists on
EasyOne Air and in EasyOne Connect, the patient data and results in
EasyOne Connect can be overwritten by EasyOne Air.
Do not copy incomplete test results from EasyOne Air to EasyOne Connect,
then change patient data or add trials, and copy data from EasyOne Air to
EasyOne Connect again.
Instead, first complete tests with EasyOne Air before you copy patient data
and results to EasyOne Connect.
Make changes to existing patient data on EasyOne Air only.
Use EasyOne Connect only
to create new patient records without results yet for sending to EasyOne Air
to evaluate results,
to print reports,
to archive patient data and results,
or to send patient data and results from EasyOne Connect to your EMR system.

EASYONE AIR MAY FREEZE

If EasyOne Air is connected to your PC via USB and if there are also electromag-
netic fields from other electrical devices nearby, EasyOne Air may freeze.
To restart EasyOne Air, turn EasyOne Air off and on again.

 To copy patient data and results from EasyOne Air to

EasyOne Connect
1 On your PC, launch EasyOne Connect.
2 Turn on EasyOne Air.
3 Put EasyOne Air into the cradle.
 Patient data and results are copied from EasyOne Air to
EasyOne Connect.
 EasyOne Connect displays a message whether the copying has been
successful.
 You can remove EasyOne Air from the cradle, or you can proceed with
the next procedure to create and send new patient records from
EasyOne Connect to EasyOne Air.

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Working with patient data and reports

 To create and send a new patient record from

EasyOne Connect to EasyOne Air
1 In EasyOne Connect, choose Patients.
2 Choose New.
3 CAUTION! False diagnosis: The predicted values and the system
interpretation are based on the patient demographic data. Therefore,
wrong patient data can cause false results. Enter patient data
meticulously. Double-check that you have entered the patient data
correctly.
Fill out those fields that are marked with an asterisk (*).
 You cannot complete adding patient data without filling out these
fields.
4 In all other fields, enter additional patient data if necessary.
5 Choose OK.
6 Select the patient record that you just have created.
7 Choose > EasyOne.
 The selected patient record is send to EasyOne Air.
 EasyOne Connect displays a message whether the sending has been
successful.
 You can remove EasyOne Air from the cradle, or you can repeat steps 2
to 7 to create and send additional patient records.
 Viewing and printing reports with EasyOne Connect, 90
Connectivity and data exchange, 44

10.2.6 Viewing and printing reports with EasyOne Connect

1 From the main menu, choose Patients.

2 Select a patient.
3 Choose History.
 The history screen with a list of tests is displayed.
4 Select a test.
5 To view the results for the selected test, do the following:
a) Choose View.
b) If the test type is provocation, choose Menu.
c) To preview the report, choose Report.
d) To print the report, choose Print.
e) To go back to the history screen, choose Return and then History.
6 To view the results of another test, repeat steps 4 and 5.
7 To view the results of another patient, choose Patients and repeat steps 2
to 6.

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Working with patient data and reports

10.2.7 About the trend view with EasyOne Connect

The trend view visualizes an increase or a decline of individual parameters.

This view facilitates the comparison of different measurements over time.
From the history screen (Patients > select patient > History), choose Trend.
The trend screen displays two curves, one for the absolute values and one for
the percentage of predicted normal values.
At the bottom of the trend screen, you can select four parameters to be
displayed at the same time.

10.2.8 Assessing tests retrospectively and entering comments with

EasyOne Connect

Retrospectively, you can manually override the acceptability of trials and the
ranking of trials. This means that you can mark trials that the system judged
acceptable as unacceptable and vice versa. Also, you can change the trial
ranking (rank 1, 2, 3, and so forth).

 To assess tests retrospectively

1 From any result screen in the parameter table, choose the Trial Rank field
for the particular trial.
 An overlay window is displayed.
2 To mark the selected trial as acceptable or unacceptable, select or deselect
the Acceptable check-box.
 If you have not activated user handling, the login window is displayed.
 If you have activated user handling, the test comment window is
displayed. In this case, proceed with step 4.
3 If the login window is displayed, enter your user ID.
 The selected trial is marked as either acceptable or unacceptable.
4 To change the ranking, choose Highest Ranked.
 You can only set the rank to 1 (highest). To set the rank of other trials to
2, 3, and so forth, you must subsequently set the rank to 1 for all trials. The
last trial that you set to rank 1 is rank 1. The second last trial that you set to
rank 1 is rank 2, and so forth.
5 To close the overlay window, choose ×.

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Working with patient data and reports

 To enter comments
1 In any result screen, select the comment area.
 If you have not activated user handling, the login window is displayed.
 If you have activated user handling, the test comment window is
displayed. In this case, proceed with step 3.
2 If the login window is displayed, enter your user ID.
 The test comment window is displayed.
3 Enter your comment and choose Save.
 Your comment is displayed on the result screen.
 About user handling and the default password of EasyOne Connect, 106

10.2.9 About exporting comprehensive data from EasyOne Connect

Utilities > Export Data

This export is the most comprehensive export function in EasyOne Connect.
You can select which data to include in the export.
Each check box produces one file with the corresponding data.
To access data on an SQL-server based database, the SQL server must accept
the Microsoft Active Directory user account that the current Windows user is
logged in with.

10.2.10 About exporting XML from EasyOne Connect

Utilities > Export XML

The XML export enables you to process patient data with your own software
tools.
In the report configurations, you can configure which data to include in the
XML export.
To access data on an SQL-server based database, the SQL server must accept
the Microsoft Active Directory user account that the current Windows user is
logged in with.
 Description of report configurations of EasyOne Connect, 116
Software Developer Guide SDK – ndd EMR plug-in

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Working with patient data and reports

10.2.11 About exporting from EasyOne Connect to EasyWare

Utilities > Export EasyWare

EasyWare is the PC software for EasyOne World, the predecessor model of
EasyOne Air. EasyWare uses a different database format.
This export is compatible with the database format of EasyWare.
To access data on an SQL-server based database, the SQL server must accept
the Microsoft Active Directory user account that the current Windows user is
logged in with.
 EasyWare Operator’s Manual

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11 Configuration

CAUTION
FALSE DIAGNOSIS
Wrong configuration settings can cause incorrect diagnostic calculations.
Be aware that wrong configuration settings can affect the predicted values,
the system interpretation, and the displayed result values.
Verify the configuration settings.

11.1 Configuration of EasyOne Air

You can configure EasyOne Air in the tools menu.

11.1.1 Configurations in the settings menu of EasyOne Air

11.1.1.1 Description of device settings of EasyOne Air

> >
On this screen, you can choose basic settings for EasyOne Air.

Setting Purpose Options Default setting

Speaker volume To set the speaker volume 0% – 100% 50%
Key click To enable sound for audible click Selected, deselected Selected
feedback
Beep during To enable a beeping signal during Selected, deselected Selected
maneuver breathing maneuvers as feedback
about air flow
User Logon required To enable password protection Selected, deselected Selected
System Time To set the time Numeric entry (Not applicable)
System Date To set the date Numeric entry (Not applicable)
Date format To set the format of the date YYY-MM-DD, MM/DD/ (Determined by
YYYY, DD.MM.YYYY regional setting at
first-time setup)
Time format To set the format of the time 24h (00:00 – 23:59), 12h (Determined by
(AM/PM) regional setting at
first-time setup)
Patient ID format To set the format of the patient ID for Numbers only, (Determined by
compliance with national standards Alphanumeric regional setting at
first-time setup)
 Description of device settings

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.1.1.2 Description of spirometry settings of EasyOne Air

> >

Predicted normal values setting

Predicted normal values are based on the latest scientific publications.
Therefore, the predicted normal values are subject to change. These changes
are delivered to you via software updates.
Updated information is published in an Application Note on the ndd website.
Application Note Reference Predicted Normal Values
Application Notes for further information, 3
List of bibliographic references, 132

Best trial/best value selection

If you choose the Best Trial option, the complete best trial is selected for
assessing the quality of the test and for assessing the interpretation. The trial
with the largest sum of FVC and FEV1 is selected, as suggested by ATS and
ERS.
If you choose the Best Value option, the best single, relevant values are
selected from different trials for assessing the quality of the test and for
assessing the interpretation. This compiled column shows, for example, the
largest FVC (or FEV6) and the largest FEV1 from all acceptable tests (unless all
tests are unacceptable). Other parameters are taken from the best trial (also
defined by the largest sum of FEV1 and FVC).

System Interpretation
Choose from the interpretation standards NLHEP, GOLD/Hardie, and NICE, or
disable automatic interpretation.
The default setting is GOLD/Hardie.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

NLHEP interpretation

START

No
7HVWVHVVLRQJRRG" Caution: interpret with care

Yes

Yes No
FEV1)9&˗//1" )9&//1" Normal spirometry

No Yes

/RZYLWDOFDSDFLW\ɠ
SRVVLEO\GXHWRUHVWULFWLRQ
RIOXQJYROXPHV

Yes
FEV1˗//1" Normal spirometry

Yes
FEV1˗SUHGLFWHG" 0LOGREVWUXFWLRQ

Yes
FEV1˗SUHGLFWHG" 0RGHUDWHREVWUXFWLRQ

6HYHUHREVWUXFWLRQ

)9&//1"

Yes

,QDGGLWLRQORZYLWDO
FDSDFLW\ɠ
SRVVLEO\GXHWRUHVWULFWLRQ
RIOXQJYROXPHV

 NLHEP interpretation algorithm

The diagram above shows how the interpretation for NLHEP is determined,
according to Ferguson (2000/NLHEP) [4].

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

GOLD/Hardie Interpretation 2003 & 2008

START

Maneuver No
No interpretation
quality OK?

Yes FEV1/FVC limit age related:

age < 70 years: 70%
\HDUV˖DJH\HDUV
DJH!\HDUV

FEV1/FVC No FVC < LLN and No

Normal spirometry
< FEV1% limit? FEV1 < LLN

Yes Yes
Obstruction
No
FEV1˗ Yes Mild Smoker?
predicted? obstruction
Yes
No

Normal
spirometry—
FEV1˗ Yes Moderate at COPD risk
predicted? obstruction
GOLD/Hardie 2003
No
only

FEV1˗ Yes Severe Restriction

predicted? obstruction

No Possible restriction

Very severe
END
obstruction

 GOLD/Hardie interpretation algorithm

The diagram above shows how the interpretation for GOLD/Hardie 2003 and
GOLD/Hardie 2008 is determined, according to GOLD (2003) [11] and Hardie
(2002) [12].
The smoker status is not part of the GOLD/Hardie standard of 2008, only of
2003.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

NICE interpretation

START

Check maneuver quality

No
FEV1/FVC < 70%

Yes

FEV1 < 80% No

Normal spirometry
of predicted?
Yes

FEV1 < 50% No

Mild obstruction
of predicted?
Yes

FEV1 < 30% No

Moderate obstruction
of predicted?
Yes

Severe obstruction

FEV1 and FVC < 80% Yes

Restrictive disorder
of predicted?
No

FEV1 < 80% Yes Normal spirometry—

of predicted? reduced FEV1
No

FVC < 80% Yes Normal spirometry—

of predicted? reduced FVC
No

Normal spirometry

 NICE interpretation algorithm

The diagram above shows how the interpretation for NICE is determined. The
NICE interpretation is mainly used in the UK.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Lung age calculation

If the Lung Age calculation check box is selected, the lung age is displayed on
the result screen and printed on the report. The lung age is only displayed if
the patient is a smoker. You can set the smoker status on the summary screen.
When the calculated lung age is lower than the patient’s actual age, the
patient’s actual age is displayed.
In the default setting, the Lung Age calculation check box is deselected.
About the summary screen, 57

Automatic QC grading
If the Automatic QC grading check box is selected, quality messages for trial
and quality grades for tests are displayed.
In the default setting, the Automatic QC grading check box is selected.
List of quality messages and quality grades, 72

End-of-maneuver criteria selection

If you choose the FVC option, the measurement continues until the end of test
criteria are met or until you end the test manually. With this setting, all the
intermediate flow values, e.g. MEF25, FEF25-75, are reported.
If you choose the FEV6 option, the measurement stops after six seconds. With
this setting, the intermediate flow values, e.g. MEF25, FEF25-75, are not
reported.
The FVC test determines the forced expiratory vital capacity. The forced
expiratory vital capacity is the maximum volume that the patient can exhale
during the FVC breathing maneuver and is indicated by the FVC value in the
report.
The FEV6 value indicates the forced expiratory volume that the patient has
exhaled after six seconds.
For diagnostic purposes, the FVC value is comparable with the FEV6 value. The
advantage of choosing the FEV6 option is that the FVC test only takes the
fixed duration of six seconds and is less demanding for the patient (see
Ferguson (2000/NLHEP) [4]). The disadvantage is that the intermediate flow
values, e.g. MEF25, FEF25-75, cannot be reported.
List of bibliographic references, 132

PEF unit
The peak expiratory flow can be specified in liters per minute (L/min) or in
liters per second (L/s).

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Ethnic correction
Some studies for predicted values take into account the differences between
certain ethnic groups. However, most studies that are used for spirometry
were conducted on Caucasian subjects and are therefore most appropriate for
use with Caucasian patients.
When entering patient information, you are presented with a list of options for
four ethnic groups. In this setting, you can define the corrections for these
ethnic groups. The adjustment is made to the values for Caucasians patients.
There is an exception to this function. If specific values are available for the
chosen group of predicted values and the chosen ethnic group, they will be
used instead of the correction entered here.
The American Thoracic Society’s publication, Lung Function Testing: Selection
of Reference Values and Interpretative Strategies [8], provides guidance on
the subject of ethnic correction. This paper recommends using 88% of the
Caucasian values when testing African patients and provides general
guidance in selecting adjustments for other ethnic groups.
List of bibliographic references, 132

11.1.1.3 Description of display settings of EasyOne Air

> >
On this screen, you can choose settings that are related to the displayed
software and to the touchscreen.

Setting Purpose Options Default setting

Language To set the language English, French, German, (Determined by
Spanish regional setting at
first-time setup)
Brightness To set the brightness of the touchscreen 1% – 100% 50%
Screensaver after To set the time, after which the 5 s – 600 s 120 s
screensaver is enabled
Power-off after To set the time, after which EasyOne Air 20 s – 1200 s 600 s
is powered off to save battery
Volume/Time curve To enable the display of the volume- Selected, deselected Selected
time curve in addition to the flow-
volume curve in the reports
Show predicted range To enable visualization of the maximum Selected, deselected Selected
curve and minimum curve in the
volume-time curve and flow-volume
curve in the reports
 Description of display settings

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.1.1.4 Description of print settings of EasyOne Air

> >
You can determine basic settings for printouts when using EasyOne Air and
the cradle. There are more comprehensive configuration options available for
printouts when using EasyOne Connect.

Setting Purpose Options Default setting

Printer To select a physical printer or a virtual PDF printer, External External printer
PDF printer (saves a PDF file) printer
Printer page format To select the page format in imperial or US, A4 A4
metric dimensions
Number of pages To select between a full-size or compact one page (compact two pages
report format report), two pages (full-
size report)
Data To set whether one or three trials are Best trial (one trial), best Best value (three
included on the printout, corresponding value (three trials) trials)
to the best trial/best value selection in
the spirometry settings
Curve To set which curves are included on the One curve, three curves Three curves
printout, corresponding to the Data
setting above
Custom header To specify four lines of text on the Text entry (Not applicable)
printout, for customizing the printout
for your institution
 Description of print settings

 Best trial/best value selection, 95

About compatible printers, 19
Setting up the physical components, 20
Description of report configurations of EasyOne Connect, 116

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.1.2 Performing a firmware update with EasyOne Air

>
Required material
 An SD memory card from the manufacturer
In this menu, you can update the firmware of EasyOne Air.

CAUTION
FAILED UPDATE
An update may fail unnoticed.
After performing an update, restart EasyOne Air and EasyOne Connect and per-
form a calibration check.
Calibration check, 119
Checking for correct operation of EasyOne Air, 122

1 Unlock and open the battery compartment by turning the lock screw
clockwise.

2 Insert the SD memory card into the SD card slot.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

3 Close and lock the battery compartment by turning the lock screw
counterclockwise.

4 Choose > .
 The firmware update that is on the SD memory card is displayed.
5 Select the firmware update from the SD memory card.
 The firmware update is performed.
 After the firmware update, a message is displayed whether the update
was successful, and EasyOne Air restarts.
6 Remove the SD memory card.

11.1.3 Performing a backup of EasyOne Air

>
Required material
• An SD memory card with at least 2 GB of free space
To archive a copy of the complete database (including patient data and
results) and of the configuration settings, perform backups regularly. You can
also use the backup to set up another EasyOne Air with the same database
and configuration settings.
For each backup, the manufacturer recommends to use one SD memory card
with 2 GB storage capacity.
1 Unlock and open the battery compartment by turning the lock screw
clockwise.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

2 Insert the SD memory card into the SD card slot.

3 Close and lock the battery compartment by turning the lock screw
counterclockwise.

4 Choose > > Backup.

 A message is displayed that asks whether you want to encrypt the
backup with a password.
5 Do one of the following:
a) To encrypt the backup with a password, choose Set password and enter
the password in the following window.
b) To proceed without setting a password, choose No password.
 The SD memory card is checked for sufficient free space.
 The complete database and all configuration settings are backed up to
the SD memory card.
 After successful completion of the backup, a message is displayed.
6 Choose the home button.
7 Remove the SD memory card.

11.1.4 About the information menu of EasyOne Air

> .
The information menu displays the firmware version of EasyOne Air.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.1.5 About the user menu of EasyOne Air

> .

Inactive user handling

If user handling is inactive, all menus and settings are exposed. Sensitive
changes, for example deleting patient data, require authentication.
The default user name / password is: admin / 8005

Active user handling

If user handling is active, users must login. User accounts can be password-
protected.
Security policies, like password strength and password expiration, must be
handled by the operating institution, for example the hospital or practice.
If user accounts are password-protected, users are only prompted for their
password once for login. For sensitive changes, like deleting patient data,
users are not prompted for their passwords again.
Instead, logs include the respective user. Therefore, sensitive changes can be
traced back to individual users.

User groups
There are two user groups: Administrator and Technician. Administrator users
have full access and privileges to all menus and functions of
EasyOne Connect. Technician users have restricted access and privileges.
At least one user has to remain as an Administrator user. Administrator users
have access to the configuration of user handling and to the EMR
configuration.

11.2 Configuration of EasyOne Connect

Utilities > Configuration

11.2.1 About saving or discarding configuration changes of EasyOne Connect

You can change the configuration in different tabs and sub-tabs. After you
have changed the configuration, you must choose the OK button, which is
visible on all screens.
To discard any changes to the configuration, choose the Cancel button. The
previous configuration stays in effect.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.2.2 About user handling and the default password of EasyOne Connect

Utilities > Configuration > General > User Handling

Inactive user handling

If user handling is inactive, all menus and settings are exposed. Sensitive
changes, for example deleting patient data, require authentication.
The default user name / password is: admin / 8005

Active user handling

11.2.3 Description of general configurations of EasyOne Connect

11.2.3.1 Utilities > Configuration > General > Header

You can set your own headers and your own graphic file, for example the
name and the logo of your institution, to be displayed in the main menu and
to be printed on reports.
The graphic file can be of any common file type, for example *.bmp or *.jpg,
with a resolution of 260x80 pixels or smaller. To select or change the graphic
file, choose Browse. To remove the graphic file, choose Remove.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.2.3.2 Utilities > Configuration > General > Storage

Element Description
Field To display the file system path of the currently active database file.
New button To create a new empty database—you must choose between a local file-based
database or an SQL-server-based database.
Select button In a new window, to select a different database file or connect EasyOne Connect as a
database client to a database server. SQL database servers are supported.
Import button To import a second database file into the currently active database—both databases
are merged. Entries that exist in both databases are not duplicated.
Backup button To save a copy of the currently active database file.
Load Configuration button To load a configuration file—a configuration file can contain settings, for example for
predicted normal values, report headers, or user handling.
Be aware that loading a configuration overrides the current configuration settings!
 Storage configuration

 About connectivity between EasyOne products, 44

Application Note EasyConnect – Database Connection
Application Notes for further information, 3

11.2.3.3 Utilities > Configuration > General > System Settings

Element Description
Length Unit options To choose between metric and imperial units.
Temperature Unit options To choose between metric and imperial units.
Weight Unit options To choose between metric and imperial units.
Hb Unit options Regarding hemoglobin, to choose between the SI unit and the traditionally used unit.
Pressure Unit options To choose between alternative units.
Language options To choose a language independent of the language of your Microsoft Windows
installation.
Show all Test/Device Settings To display settings for EasyOne Pro/LAB.
check box
Patient Entry options To choose between different entry formats for the patient’s age.
 System Settings

The default configurations in this tab are determined by your language

settings and by your regional settings in Microsoft Windows.

11.2.3.4 Activating user handling and administering user accounts

1 Choose Utilties > Configuration > General > User Handling.
2 Enter the default password 8005 and choose Login.
3 To activate user handling, select the User Handling check box.
4 To add a user, do the following:
a) Choose Add.
b) Enter a user ID.
c) Enter additional information as required.
d) Choose OK.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

5 To edit a user, do the following:

a) Select an existing user.
b) Edit information as required.
c) Choose OK.
6 To delete a user, do the following:
a) Select an existing user.
b) Choose Delete.
c) Confirm the following message.
7 To save the changes, choose OK.
8 To discard the changes, choose Cancel.
 About user handling and the default password of EasyOne Connect, 106

11.2.4 Description of test configurations of EasyOne Connect

11.2.4.1 Utilities > Configuration > Test > General

Best trial/best value selection

Curve Overlay
To select which trials are to be displayed in the flow-volume curve and the
volume-time curve on the test result screens, choose the corresponding
check box.
By default, + Session Best and + Pre Best are selected.

Test Procedure
If you deselect Manual Test Stop, you enable automatic test stop.
By default, Manual Test Stop is selected.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

General
To display on the test result screens a comparison of the best trial and the
predicted values as percentage values also for the post, choose Show %
predicted column for post tests.
To display ratio parameters (for example FEV1/FVC) as a percentage (for
example 78%) instead of a decimal ratio (for example 0.78), choose Show
ratio parameter in %.
By default, both check boxes are deselected.
To set the maximum number of trials for forced and slow spirometry enter a
value between 1 and 99 in the text field Max Number of Trials Forced/Slow.
The default value is 99. The text fields DLCO and MBW do not apply to the
EasyOne Connect PC software, but to the firmware of EasyOne Pro/LAB only. A
change of the values DLCO and MBW is without effect for the EasyOne Connect
PC software.

11.2.4.2 Utilities > Configuration > Test > Predicted

Predicted normal values setting

System Interpretation
Choose from the interpretation standards NLHEP, GOLD/Hardie, and NICE, or
disable automatic interpretation.
The default setting is GOLD/Hardie.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

NLHEP interpretation

START

No
7HVWVHVVLRQJRRG" Caution: interpret with care

Yes

Yes No
FEV1)9&˗//1" )9&//1" Normal spirometry

No Yes

/RZYLWDOFDSDFLW\ɠ
SRVVLEO\GXHWRUHVWULFWLRQ
RIOXQJYROXPHV

Yes
FEV1˗//1" Normal spirometry

Yes
FEV1˗SUHGLFWHG" 0LOGREVWUXFWLRQ

Yes
FEV1˗SUHGLFWHG" 0RGHUDWHREVWUXFWLRQ

6HYHUHREVWUXFWLRQ

)9&//1"

Yes

,QDGGLWLRQORZYLWDO
FDSDFLW\ɠ
SRVVLEO\GXHWRUHVWULFWLRQ
RIOXQJYROXPHV

 NLHEP interpretation algorithm

The diagram above shows how the interpretation for NLHEP is determined,
according to Ferguson (2000/NLHEP) [4].

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

GOLD/Hardie Interpretation 2003 & 2008

START

Maneuver No
No interpretation
quality OK?

Yes FEV1/FVC limit age related:

age < 70 years: 70%
\HDUV˖DJH\HDUV
DJH!\HDUV

FEV1/FVC No FVC < LLN and No

Normal spirometry
< FEV1% limit? FEV1 < LLN

Yes Yes
Obstruction
No
FEV1˗ Yes Mild Smoker?
predicted? obstruction
Yes
No

Normal
spirometry—
FEV1˗ Yes Moderate at COPD risk
predicted? obstruction
GOLD/Hardie 2003
No
only

FEV1˗ Yes Severe Restriction

predicted? obstruction

No Possible restriction

Very severe
END
obstruction

 GOLD/Hardie interpretation algorithm

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

NICE interpretation

START

Check maneuver quality

No
FEV1/FVC < 70%

Yes

FEV1 < 80% No

Normal spirometry
of predicted?
Yes

FEV1 < 50% No

Mild obstruction
of predicted?
Yes

FEV1 < 30% No

Moderate obstruction
of predicted?
Yes

Severe obstruction

FEV1 and FVC < 80% Yes

Restrictive disorder
of predicted?
No

FEV1 < 80% Yes Normal spirometry—

of predicted? reduced FEV1
No

FVC < 80% Yes Normal spirometry—

of predicted? reduced FVC
No

Normal spirometry

 NICE interpretation algorithm

The diagram above shows how the interpretation for NICE is determined. The
NICE interpretation is mainly used in the UK.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.2.4.3 Recalculating predicted values of previous test results

EasyOne Connect can recalculate predicted values using a different
publication. This procedure affects all records in the database. Therefore,
exporting the database as a backup is recommended prior to changing all
records.
Prerequisite
 You have exported the database as a backup.
About exporting comprehensive data from EasyOne Connect, 92
1 Choose Utilities > Configuration > Test > Predicted.
2 From the Predicted drop-down lists, choose the required publication.
3 Choose Update Tests.
 If you have not activated user handling, the login window is displayed.
 If you have activated user handling, the information window is
displayed. In this case, proceed with step 5.
4 If the login window is displayed, enter your user ID.
 The information window is displayed.
5 In the information window, review and confirm the selected changes.
 All records in the database are updated.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.2.4.4 Utilities > Configuration > Test > FVC / FVL

Type
First, the setting FVC, Ex. only or FVL, Ex./In. determines whether the
bronchial provocation test is performed using an FVC test or an FVL test.
Second, if you have integrated EasyOne Connect with your EMR system and if
you use the GDT plug-in, the setting FVC, Ex. only or FVL, Ex./In. is also
relevant. With this setting, you can configure which test of the two is initiated
when the EMR system requests forced spirometry.
To allow the patient to breathe regularly through the EasyOne Flow Tube
before the breathing maneuver, choose Tidal Breathing. This check box is
only available when Manual Test Stop is selected under Utilities
> Configuration > Test > General > Test Procedure.
About integration of EMR systems, 45
Test Procedure, 108

End-of-maneuver criteria selection

Parameter
To select which diagnostic parameters to include on the test result screens
and on the printed reports, choose Select FVC and Select FVL.
Viewing and printing reports with EasyOne Connect, 90

Predicted graph
To visualize predicted values in the flow-volume curve and the volume-time
curve on the test result screens and on the printed reports, choose Show
predicted points and Show predicted range.
Operator’s Manual • EasyOne Air • EasyOne Connect • V01
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 114/143 118
Configuration

Print Lung Age

You can choose to print the lung age on reports. When the calculated lung age
is lower than the patient’s actual age, the patient’s actual age is displayed.
To display the lung age only for smokers, choose Smoker only from the drop-
down list. You can set a patient’s smoker status when you add patient data to
the database or edit patient data.
To always display the lung age, choose On.
To never display the lung age, choose Off.
The default configuration is Smoker only.
Adding patient data to the database of EasyOne Connect, 87
Editing patient data with EasyOne Connect, 87

11.2.4.5 Utilities > Configuration > Test > SVC

Type
To make regular breathing mandatory before the breathing maneuver, choose
Tidal Breathing Required.

11.2.4.6 Utilities > Configuration > Test > MVV

11.2.4.7 Utilities > Configuration > Test > CalCheck

Syringe Volume
Calibration syringes are available in various sizes. You can choose the volume
of the calibration syringe from the drop-down list.

Type Selection
One test with three trials is required for the Single Flow calibration check. For
the Multi Flow calibration check, three tests comprising three trials, each with
different flow rates, are required.

Reported Graph
You can select which type of curve you prefer for the calibration check report.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.2.4.8 Utilities > Configuration > Test > Provocation

Protocol
Different protocols for the provocation test are available using Mannitol and
Methacholine as provocative agents.
Choose the protocol from the drop-down list.

11.2.5 Description of device configurations of EasyOne Connect

Utilities > Configuration > Device

You can use EasyOne Connect in combination with any ndd spirometer.

Easy on-PC
This tab displays hardware information about the connected
Easy on-PC sensor.
If the Easy on-PC sensor cannot connect, the serial COM port might be used
by another device. To switch to a free serial COM port, you can manually select
one from the drop-down list or choose the Auto Detect button.
Easy on-PC Operator’s Manual

EasyOne Air

Utilities > Configuration > Device > Selection

From this tab, select the device that you want to use for performing spirometry
with EasyOne Connect.

11.2.6 Description of report configurations of EasyOne Connect

Utilities > Configuration > Report

Layout

CAUTION
MISINTERPRETATION OF RESULTS
Reports that are labeled as Custom Report are not validated.
Use customized reports at your own risk.

The layout editor allows for customization of the reports’ layout.

For details, contact your EasyOne dealer or the ndd Servicing Department.
Contact information, 4

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

XML Export
If you do not require curve data or trial values in exported XML, you can
exclude this data by deselecting the check boxes.
By default, these check boxes are selected.
About exporting XML from EasyOne Connect, 92

11.2.7 Loading and selecting a custom report layout of EasyOne Connect

You can load custom report layouts according to your requirements. For easy
identification you can rename the report layouts. Your EasyOne Air dealer or
the ndd Servicing Department can assist you in creating a custom report
layout.
Prerequisite
 You have created or received a report layout file with an *.repx file
extension.
 You have connected the drive with the report layout file, or you have
copied the report layout file to PC that runs EasyOne Connect.
If you want to rename the report layout, you only need to rename the REPX file.
The name of the report layout file is printed on every report.

 To load the report layout file

1 Choose Utilities > Configuration > Report.
2 Choose Load.
3 Navigate to the report layout file, select the file, and choose Open.
4 Read and confirm the warning message about custom report layouts.

 To select your custom report layout

1 From any result screen, choose Report.
2 From the Layout Selection drop-down list in the top left, choose your
custom report layout.

11.2.8 Description of printer configurations of EasyOne Connect

Utilities > Configuration > Printer

From the drop-down list, choose a printer. To be displayed in the drop-down
list, the printer must be installed in Microsoft Windows.
With the Refresh button, you can refresh the drop-down list after you have
installed a new printer in Microsoft Windows.
With the System Default button, you choose the printer that is set as the
default printer in Microsoft Windows.
 About compatible printers, 19

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

11.2.9 Description of environment configurations of EasyOne Connect

Utilities > Configuration > Environment

The environment conditions are required to accurately calculate the
diagnostic parameters from the raw sensor data.
If you select the check box, you are prompted every two hours to enter the
environment conditions when performing spirometry.
From the environment conditions, the ATPS values (Ambient Temperature
Pressure Saturated), which describe the conditions for the spirometer, are
calculated. The ATPS values are converted to BTPS values (Body Temperature
Pressure Saturated), which describe the body conditions of the patient.
If you choose one of the following tests, you are prompted for the current
environment conditions:
• FVL test
• MVV test
• SVC test
• Provocation test (if the FVL test is configured for the provocation test)

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

12 Calibration check

CAUTION
FALSE DIAGNOSIS
A number of reasons can lead to malfunction of EasyOne Air, and malfunction
of EasyOne Air can lead to false results and false diagnosis.
Perform calibration checks periodically, according to ATS/ERS.
Calibration check, 119
Checking for correct operation of EasyOne Air, 122

MALFUNCTION
Calibration of EasyOne Air is not possible. You can merely check EasyOne Air
for correct calibration.
Do not attempt to repair EasyOne Air yourself. A third-party service must not at-
tempt to repair EasyOne Air either.
Do not open or remove the casing.
If a calibration check fails, contact only your EasyOne dealer or the
ndd Servicing Department for repairs.
Contact information, 4

12.1 About calibration check with EasyOne Air

There are three types of calibration checks: single cal check, multi-flow cal
check, and linearity cal check.

Single cal check

Single cal check is not standard-compliant. The manufacturer recommends
multi-flow cal check and linearity cal check.
With single cal check, you simulate one inspiration and one expiration in a
single trial. The measured volume must be within ±3.5% accuracy. You can
perform multiple trials.
EasyOne Air displays exclusively the best trial. But all trials are stored. The
printout shows the best three trials.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Multi-flow cal check

With multi-flow cal check, you simulate one inspiration and one expiration for
three different flow levels each:
• 3 L in approximately 0.5 s (flow rate of 6 L/s)
The trial is accepted if the parameter FEF25-75 or FIF25-75 is between
5.50 L/s and 6.50 L/s.
• 3 L in approximately 3 s (flow rate of 1 L/s)
The trial is accepted if the parameter FEF25-75 or FIF25-75 is between
0.75 L/s and 1.25 L/s.
• 3 L in approximately 6 s (flow rate of 0.5 L/s)
The trial is accepted if the parameter FEF25-75 or FIF25-75 is between
0.40 L/s and 0.75 L/s.
To pass the complete calibration check, there must be one acceptable trial for
each flow level.
The printout shows at least three trials, one for each flow level.

Linearity cal check

The procedure for linearity cal check is the same as for multi-flow cal check,
except that three acceptable trials for each flow level are required.
The printout shows at least nine trials, three for each flow level.
 List of tests and parameters, 36

12.2 Performing a calibration check with EasyOne Air

>
Required materials
 A calibration syringe (separately available)
 An EasyOne Flow Tube cal check adapter (separately available)
 An EasyOne Flow Tube
The ultrasonic sensor of EasyOne Air does not require calibration. Only
unforeseeable reasons can lead to a malfunction that affects results. In these
cases, you can determine whether EasyOne Air operates normally with a
simple calibration check. Therefore, a regular calibration check is
recommended to ensure the reliability of the tests. The American Thoracic
Society (ATS) recommends that calibration must be checked periodically.
For criteria for acceptable trials, refer to the previous chapter.
About calibration check with EasyOne Air, 119
1 To assure that the temperature inside the syringe and the room
temperature are the same, push and draw the piston five times.
 A temperature difference may lead to a failed calibration check.
 Do not warm the body of the calibration syringe with your hands.

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

2 Push the piston of the calibration syringe all the way in.
3 Unwrap the EasyOne Flow Tube.
4 Insert the EasyOne Flow Tube into EasyOne Air.
 The shape of the EasyOne Flow Tube and the EasyOne Flow Tube holder
guide the orientation of the EasyOne Flow Tube. You can only insert the
EasyOne Flow Tube fully if it is positioned correctly.
5 Attach the EasyOne Flow Tube cal check adapter to the calibration syringe.
 To avoid any temperature differences, fixate the syringe with two
fingers at the one end of the syringe only.
6 Attach the nozzle of the EasyOne Flow Tube cal check adapter to the
EasyOne Flow Tube and make sure that the piston is fully inserted.
The EasyOne Flow Tube snaps into the nozzle of the EasyOne Flow Tube cal
check adapter.

7 Choose > > Single flow, Multi flow, or Linearity and confirm the
message that is displayed.
8 Wait for the baseline to be set.
9 Pull the piston all the way out as slow or as fast as required by the flow level
that is displayed.
10 Push the piston all the way in again with the same speed.
11 To end the maneuver, pull the piston briefly again.
 If the maneuver was not acceptable, you need to repeat steps 9 to 11.
 If you have chosen Single flow before and the maneuver was
acceptable, the calibration check is completed.
 If you have chosen Multi flow or Linearity before and the maneuver was
acceptable, proceed with step 12.
12 If you have chosen Multi flow or Linearity before and the previous
maneuver was acceptable, perform the next maneuvers according to the
messages that are displayed.
 If a maneuver was not acceptable, you need to repeat steps 9 to 11.
 If all maneuvers were acceptable, the calibration check is completed.
 List of troubleshooting solutions, 123
Contact information, 4

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Servicing and troubleshooting

13 Servicing and troubleshooting

13.1 About charging the battery of EasyOne Air

The rechargeable battery of EasyOne Air lasts for an entire working day. To
fully charge the battery after a day of work, the manufacturer recommends to
charge EasyOne Air over night. In addition, you can also charge EasyOne Air
multiple times during the day between spirometry tests.
To charge EasyOne Air, always use the cradle and an original power supply
released by the manufacturer.
 Setting up the physical components, 20

13.2 Checking for correct operation of EasyOne Air

1 Perform a calibration check.

2 Perform a spirometry test on yourself or on another known subject.
3 Check the results of steps 1 and 2 for plausibility.
a) If the results of steps 1 and 2 are plausible, EasyOne Air operates
correctly.
b) If the results of steps 1 and 2 are not plausible, troubleshoot.
c) If you are not able to remedy the defect, contact your EasyOne dealer or
the ndd Servicing Department.
 Calibration check, 119
Performing spirometry, 52
List of troubleshooting solutions, 123
Contact information, 4

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Servicing and troubleshooting

13.3 List of troubleshooting solutions

If you encounter problems operating EasyOne Air, consult the table below.

Problem Possible cause Solution

EasyOne Air cannot be switched Battery is dead. Replace the battery.
on.
You did not press and hold the ON/OFF Press and hold the ON/OFF key for at
key for at least 2 seconds. least 2 seconds.
When the EasyOne Air is switched The spirometer is defective. Consult your EasyOne dealer or the
on, you hear three consecutive ndd Servicing Department.
tones as a warning signal.
When EasyOne Air is switched on, The spirometer is possibly defective. Turn the spirometer off and on. Try again.
you see the following message on If you receive the same message again,
the display: “Self-test failed” contact your EasyOne dealer or the
ndd Servicing Department.
When EasyOne Air is switched on, An EasyOne Flow Tube was inserted while Wait for EasyOne Air to finish starting up
the message “device self test EasyOne Air was switched on. before you insert an EasyOne Flow Tube.
error #20” appears on the The EasyOne Flow Tube was not inserted Insert the EasyOne Flow Tube as
touchscreen. correctly. displayed in To prepare the test, 59.
Every time you switch EasyOne Air The internal battery of EasyOne Air is Consult your EasyOne dealer or the
on, you are prompted to enter defective. ndd Servicing Department.
Date etc.
When you start a test, you see the The EasyOne Flow Tube is not correctly Ensure the EasyOne Flow Tube is inserted
following message: “Please insert positioned. correctly and fully pushed in.
EasyOne Flow Tube correctly”
EasyOne Air is outside of ±3.5% The EasyOne Flow Tube is not correctly Insert the EasyOne Flow Tube correctly.
when conducting the calibration positioned.
check. You have not used an ndd adapter. Use the EasyOne Flow Tube cal check
adapter.
There are leaks in the syringe connection. Check the connections.
The specified syringe volume does not Choose the correct syringe volume under
correspond to the actual syringe volume. “Configuration”.
The curve is missing on the The ink cartridge of your printer is empty. Replace the cartridge.
printout.
In the configuration of your EasyOne Air, Go to “Configuration”, then “Report
a black and white printer is selected, but Settings” and select the right printer.
you actually use a color printer.
When printing a report, the printer A wrong printer type has been selected in Set the correct printer.
prints meaningless characters, or the settings.
the printer does not respond. The printer cable is not correctly Switch off the spirometer and printer.
connected or is defective. Check all plug connections.
The printer is not switched on or is not Ensure that the printer is switched on and
ready. also has paper. Switch the printer off and
back on again.
EasyOne Air is not correctly positioned on Insert EasyOne Air correctly into the base
the base unit. unit.
 Troubleshooting solutions

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Servicing and troubleshooting

Problem Possible cause Solution

If EasyOne Flow Tube is not An EasyOne Flow Tube was inserted while Try again with the EasyOne Flow Tube
inserted correctly or if the EasyOne Air was switched on the inserted correctly. If you receive the same
EasyOne Flow Tube detection is instrument, or the EasyOne Flow Tube was message again, contact your
not working correctly. not inserted correctly. EasyOne dealer or the
ndd Servicing Department.
Wireless connection to external Bluetooth is not enabled, Enable Bluetooth (configuration),
device is not working correctly. or distance is too far, make sure device is close enough (within
or Bluetooth is already connected to 5 meters or 16.4 feet),
another device. check setup.
 Troubleshooting solutions

 List of quality messages and quality grades, 72

Contact information, 4

13.4 About reactivating EasyOne Air after storage

After storing EasyOne Air for longer than approximately 8 hours without the
battery, you must reactivate EasyOne Air.
Make sure that EasyOne Air has been stored under the specified storage
conditions. If EasyOne Air has not been stored under correct conditions, or if
you cannot verify the conditions, do not proceed. Contact your
EasyOne dealer or the ndd Servicing Department.
To reactivate EasyOne Air, you must setup EasyOne Air like you did for the
first-time setup.
 List of specifications for EasyOne Air, 125
About charging the battery of EasyOne Air, 122
Setting up the EasyOne Air spirometer, 24
Checking for correct operation of EasyOne Air, 122
Contact information, 4

13.5 Exporting logging information

EasyOne Connect can export logging information. The ndd Servicing

Department or your own technical staff may require logging information to
determine the source of a problem.
1 Choose Utilities > Export Data.
2 Select Logging Information and deselect all other check boxes.
3 Choose Export.
4 Select a location in your file system where you to save the log file, for
example, a USB flash drive.
5 Choose OK.
 A confirmation is displayed when the export has been successful.
 Contact information, 4

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Specifications and bibliography

14 Specifications and bibliography

14.1 List of specifications for EasyOne Air

Size 87 x 155 x 36 millimeters (3.4 x 6.1 x 1.4 inches)

Weight without battery 302 grams (11 ounces)
with battery 356 grams (13 ounces)
Measuring accuracy Volume ±2% or 0.050 L
Flow, except PEF ±2% or 0.020 L/s
PEF ±5% or 0.200 L/s
MVV ±5% or 5 L/min
Measuring resolution Volume 1 mL
Flow 4 mL/s
Measuring range Volume ±12 L
Flow ±16 L/s
Resistance 0.3 cm H2O/L/s at 16 L/s
Measurement principle Ultrasonic transit-time measurement
Display 320 x 240 LCD display
Input method Touchscreen
Test storage capacity Up to 10,000 tests
Languages English, French, German, Spanish
Data Management EasyOne Connect PC software
Printing option Direct to printer or with EasyOne Connect PC software
Export/EMR HL7, XML, GDT (with EasyOne Connect PC software)
Hardware interface USB, Bluetooth
Age range for patients Spirometry >4 years
Respiratory tube Disposable EasyOne Flow Tube respiratory tube
Power supply Rechargeable lithium-ion battery, USB power supply
Voltage (EasyOne Air) Input 4.5 V to 5.5 V
Output 3.6 V
Power consumption Up to 7.5 W
(EasyOne Air)
Voltage (ndd power 5 V DC
supply) Standby 0.3 W
Nominal input 100 to 240 V AC, 50 to 60 Hz
voltage
Appliance class Class II
 Specifications for EasyOne Air

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Specifications and bibliography

Instrument Type BF applied part

classification Powered internally with a lithium-ion battery
Short time operation, less than 10 minutes
Instrument not suitable for use in areas with flammable anesthetic gases
and in areas with mixtures containing O2 or NO
Wireless connection Type Bluetooth: v2.1 + EDR, v3.0 + HS, WiFi : IEEE 802.11a/b/g/j,
v4.0 802.11n, 802.11d/e/i/w, 802.1X,
802.11k/r/v, 802.11h
Modulation Bluetooth: GFSK, DQPSK, 8DPSK WiFi: OFDM with BPSK, QPSK,
16-QAM, 64-QAM 802.11b with CCK
and DSSS
QoS WMM and WMM Power Save Support
Frequency band Bluetooth: 2.402 GHz to 2.480 GHz WiFi: 2412 MHz – 2484 MHz
and 4910 MHz – 5825 MHz
Transmit power Bluetooth: 15 dBm (class-1) WiFi: 18dBm
Receive sensitivity Bluetooth: -94dBm WiFi: -97dBm
Contains FCC ID: XF6-RS9113SB
transmitter module IC ID: 8407A-RS9113SB
Storage conditions Temperature -20°C to 50°C (-4°F to 122°F)
Relative humidity 5% to 90%
Atmospheric 500 hPa to 1060 hPa
pressure
Battery removed battery
Operating conditions Temperature 0°C to 40°C (32°F to 104°F)
Relative humidity 5% to 90%
Atmospheric 700 hPa to 1060 hPa
pressure
 Specifications for EasyOne Air

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Specifications and bibliography

Certifications and International IEC 60601-1 Medical electrical equipment. General requirements for
standards standards basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment. General requirements for
basic safety and essential performance. Collateral standard.
Electromagnetic compatibility. Requirements and tests
IEC 62304 Medical device software – Software life cycle processes
IEC 62366 Medical devices. Application of usability engineering to
medical devices
ISO 13485 Medical devices — Quality management systems —
Requirements for regulatory purposes
ISO 14971 Medical devices. Application of risk management to medical
devices
ISO 26782 Anesthetic and respiratory equipment. Spirometers intended
for the measurement of time forced expired volumes in humans
ISO 23747 Anesthetic and respiratory equipment. Peak expiratory flow
meters for the assessment of pulmonary function in spontaneously
breathing humans
EU CE marked, EC declaration of conformity, see on the ndd website under
“Certificates”
US FDA 510(k) market clearance
Associations and ATS/ERS 2005, NIOSH, OSHA
institutes
Life time 7 years
 Specifications for EasyOne Air

 List of tests and parameters, 36

Application Note Reference Predicted Normal Values
Application Notes for further information, 3
Contact information, 4

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Specifications and bibliography

14.2 List of specifications for the lithium-ion battery of EasyOne Air

CAUTION
RISK OF PERSONAL INJURY
Do not expose the battery to fire or dispose of the battery in fire.
Do not put the battery in a charger or equipment with wrong terminals connect-
ed.
Do not short circuit.
Avoid excessive physical shock or vibration.
Do not disassemble or deform the battery.
Do not immerse in water.
Do not use the battery in combination with any other batteries.
Keep out of the reach of children.
Only charge the battery when inside of EasyOne Air and in conjunction with the
cradle and the power supply provided by the manufacturer.
Never use a modified or damaged EasyOne Air, cradle, or power supply.
Store the battery in a cool, dry and well-ventilated area.
Dispose of the battery in accordance with local regulations. Regulations vary
for different countries.

RISK OF FIRE AND BURNS

Do not open, crush, heat above 50°C/122°F, or incinerate.
Follow the instructions in this Operator’s Manual.

The following table contains additional information about the battery of

EasyOne Air that might be required by a third party testing and certification
organization.

Manufacturer CTU Ltd.

Second Floor
Zhongxing Industrial Zone Chuang Ye
Rd. Nanshan Shenzhen 518054
China
Model Lithium-ion Battery Pack 1ICR1865
Size 20 millimeters x 71 millimeters (0.79 x 2.80 inches),
cylindrical
Weight 54 grams (1.9 ounces)
Nominal capacity 3400 mAh, 12.06 Wh
Nominal voltage 3.6 V DC
Charge current (C-rate) 0.5C
Standard charging method 1) 0.5C constant current up to 4.2 V
2) Constant voltage of 4.2 V until charge current declines to
≤0.01C
Charging time with standard Approximately 5 h
charging method
 Specifications for the lithium-ion battery of EasyOne Air

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Specifications and bibliography

Maximum charging method 1) 0.7C constant current up to 4.2 V

2) Constant voltage of 4.2 V until charge current declines to
≤0.01C
Charge cut-off voltage 4.2 V to 4.25 V
Standard discharge current (C-rate) 0.2C constant current down to end voltage of 3.0 V
Maximum discharge current 0.7C constant current down to end voltage of 3.0 V
(C-rate)
Discharge cut off- voltage 2.8 V to 3.0 V
Initial impedance ≤200 mΩ
The following standard conditions are identical to the conditions of EasyOne Air. Storage and operation under these
conditions is safe.
Standard storage conditions Temperature -20°C to 50°C (-4°F to 122°F)
Relative humidity 5% to 90%
Atmospheric pressure 500 hPa to 1060 hPa
Battery removed battery
Standard operating conditions Temperature 0°C to 40°C (32°F to 104°F)
Relative humidity 5% to 90%
Atmospheric pressure 700 hPa to 1060 hPa
The following optimized conditions prolong the life expectancy of the battery.
Optimized environmental Temperature 23±5°C (73.4±9°F)
conditions Humidity 45% to 75% relative humidity
Atmospheric Pressure 860 hPa to 1060 hPa
Optimized operating conditions Charging 0°C to 45°C (32°F to 113°F)
while charging and discharging 45% to 85% relative humidity
Discharging -20°C to 60°C (-4°F to 140°F)
45% to 85% relative humidity
Optimized storage periods and Storage period -20°C to 60°C (-4°F to 140°F)
storage conditions resulting in no ≤1 month 45% to 85% relative humidity
less than 80% recoverable capacity
of the initial capacity Storage period -20°C to 45°C (-4°F to 113°F)
≤3 months 45% to 85% relative humidity
Storage period ≤1 year -20°C to 20°C (-4°F to 68°F)
45% to 85% relative humidity
 Specifications for the lithium-ion battery of EasyOne Air

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Specifications and bibliography

Icons on the battery The battery complies with the requirements of applicable
EC directives of the European Union.

Consult instructions for use.

Caution, consult accompanying documents.

In the European Union, the product you have purchased

should not be disposed of as unsorted municipal waste.
Please make use of your local WEEE collection facilities to
dispose of this product and otherwise observe all
applicable requirements.
The battery was certified for the US market by SGS CSTC
Standards Technical Services Co., Ltd., Shanghai in project
number 710351.

 Specifications for the lithium-ion battery of EasyOne Air

14.3 List of order numbers and accessories for EasyOne Air

Item Description Intended region Order number

EasyOne Air US type A package EasyOne Air complete package with United States of 2500-2A
device, power plug and adapter, America
cradle, USB cables, battery pack, etc.
EasyOne Air EU type C package EasyOne Air complete package with European Union 2500-3C
device, power plug and adapter, (excluding United
cradle, USB cables, battery pack, etc. Kingdom)
EasyOne Air AUS type I EasyOne Air complete package with Australia 2500-4I
device, power plug and adapter,
cradle, USB cables, battery pack, etc.
EasyOne Air UK type G package EasyOne Air complete package with United Kingdom 2500-5G
device, power plug and adapter,
cradle, USB cables, battery pack, etc.
EasyOne Air IND type M package EasyOne Air complete package with India 2500-6MJKM
device, power plug and adapter,
cradle, USB cables, battery pack, etc.
EasyOne Flow Tube box of 50 pcs. EasyOne Flow Tube, individually Worldwide 5050-50
wrapped, box of 50 pieces
EasyOne Flow Tube box of 200 pcs. EasyOne Flow Tube, individually Worldwide 5050-200
wrapped, box of 200 pieces
EasyOne Flow Tube box of 500 pcs. EasyOne Flow Tube, individually Worldwide 5050-500
wrapped, box of 500 pieces
ndd calibration syringe 3 L with ndd calibration syringe 3 liters, for Worldwide 5030-1
EasyOne Flow Tube cal check adapter optional calibration check
procedures, includes an
EasyOne Flow Tube cal check adapter
 Order numbers and accessories for EasyOne Air

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Specifications and bibliography

Item Description Intended region Order number

EasyOne Flow Tube cal check adapter Individual cal check adapter for use Worldwide 5030-2
with ndd calibration syringe and
EasyOne Flow Tube
EasyOne Air USB cable B–micro USB cable from cradle to printer Worldwide 2500-50.1
(cradle to printer) (replacement)
EasyOne Air battery pack Battery pack for EasyOne Air Worldwide 2500-50.4
(replacement)
EasyOne Air power supply with Power supply with adapter for United States of 2500-50.5A
adapter type A EasyOne Air power supply with America
adapter (replacement)
EasyOne Air power supply with Power supply with adapter for European Union 2500-50.5C
adapter type C EasyOne Air power supply with (excluding United
adapter (replacement) Kingdom)
EasyOne Air power supply with Power supply with adapter for Australia 2500-50.5I
adapter type I EasyOne Air power supply with
adapter (replacement)
EasyOne Air power supply with Power supply with adapter for United Kingdom 2500-50.5G
adapter type G EasyOne Air power supply with
adapter (replacement)
EasyOne Air power supply with Power supply with adapter for India 2500-50.5MJKM
adapter type M EasyOne Air power supply with
adapter (replacement)
 Order numbers and accessories for EasyOne Air

14.4 List of system requirements for EasyOne Connect

To install EasyOne Connect, make sure that your PC EasyOne Connect meets
the following system requirements:

Operating system Microsoft Windows 7, Microsoft Windows 8 and 8.1 (32 bit and 64 bit), Microsoft Windows 10
(32 bit and 64 bit)
Hard disk capacity 1 GB (software)
4 GB (database)
RAM 2 GB
 System requirements for EasyOne Connect

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Specifications and bibliography

14.5 List of bibliographic references

[1] American Thoracic Society. Standardization of Spirometry: 1994 Update,

Nov. 11, 1994. American Journal of Respiratory and Critical Care
Medicine, Vol 152, 1995, pp 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 et al. Office spirometry for lung health assessment in adults: a
consensus statement from the National Lung Health Education Program.
Chest Journal, Vol 117, 2000, pp 1146-1161.
[5] ATS Pulmonary Function Laboratory Management and Procedure Manual.
American Thoracic Society, New York, NY 10019.
[6] Enright, Hyatt. Office Spirometry. Lea & Febiger, Philadelphia, 1987
[7] Hyatt, Scanlon, Nakamura. 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. American Review of Respiratory
Disease, Vol 144, 1991, pp 1202-1218.
[9] Morris, Temple. Short Report: Spirometric “Lung Age” Estimation for
Motivating Smoking Cessation. Preventive Medicine, Vol 14, 1985,
pp 655-662.
[10] Polgar, Promadhat. Pulmonary Function Testing in Children: Techniques
and Standards. W.B. Saunders Co., Philadelphia, 1971.
[11] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management and Prevention of Chronic
Obstructive Pulmonary Disease. Executive Summary, Updated 2003.
[12] Hardie et al. Risk of over-diagnosis of COPD in asymptomatic elderly
never-smokers. European Respiratory Journal, Vol 20, 2002,
pp 1117-1122.
[13] Miller et al. ATS/ERS Task Force: Standardization of Lung Function Testing.
Numbers 1 to 5, European Respiratory Journal, Vol 26, 2005, pp 153-161,
319-338, 511-522, 720-735, 948-968.
[14] Beydon et al. An Official American Thoracic Society/European Respiratory
Society Statement: Pulmonary Function Testing in Preschool Children.
American Journal of Respiratory and Critical Care Medicine, Vol 175,
2007, pp 1304–1345.
[15] Occupational Safety and Health Administration. Spirometry Testing in
Occupational Health Programs: Best Practices for Healthcare
Professionals. OSHA 3637-03, 2013.
 Application Note Reference Predicted Normal Values
Application Notes for further information, 3

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

15 Index

A Charging the battery ...................................... 122

Cleaning
Abbreviations ................................................. 38 avoiding contamination .............................. 81
Access rights, users .............................. 105, 106 cleaning the system ................................... 82
Accessories, order numbers ........................... 130 hygiene ..................................................... 81
Accounts, administering user accounts .......... 107 Code, quality messages ................................... 72
Addresses ........................................................ 4 Comments, entering ........................................ 91
Administrator, user group ...................... 105, 106 Comparing trials ........................................... 109
Algorithms, interpretation algorithms ....... 95, 109 Configuration
ATPS (Ambient Temperature Pressure Saturated) ... database ................................................. 107
118 environmental conditions ......................... 118
menu in EasyOne Connect ......................... 105
B overview .................................................... 94
printer ..................................................... 117
Backups ......................................................... 41
reports .................................................... 116
Battery
saving configuration changes ................... 105
charging .................................................. 122
settings menu on EasyOne Air ..................... 94
specifications .......................................... 128
storage configuration ............................... 107
Best Trial option ..................................... 95, 108
XML exports ............................................. 117
Best Value option .................................... 95, 108
see also, settings
Bibliography ................................................. 132
Connections
Box contents ................................................... 17
EasyOne Air to EasyOne Connect ................. 64
Breathing maneuver
external devices, requirements ................... 15
definition ................................................... 35
physical components .................................. 20
explaining to the patient ............................. 53
Connectivity ................................................... 44
FVC test ..................................................... 76
Contact information ...................................... 3, 4
FVL test ...................................................... 77
Contamination, avoiding ................................. 81
MVV test .................................................... 79
Curve
OSHA test .................................................. 78
definition ................................................... 35
overview .................................................... 76
overlay .................................................... 108
quality messages ....................................... 72
type, calibration check report .................... 115
setting regular breathing as mandatory ..... 115
Custom EMR plug-in ...................... 48, 49, 50, 51
SVC test ..................................................... 80
Cybersecurity .................................................. 40
Tidal Breathing Required option ................ 115
Bronchial provocation ..................................... 35
Bronchodilation .............................................. 55
BTPS (Body Temperature Pressure Saturated) . 118

C
Calibration
choosing syringe volume .......................... 115
Multiflow calibration check ....................... 115
result messages ......................................... 72
selecting calibration check type ................ 115
selecting curve type for report ................... 115
Single Flow calibration check .................... 115
Calibration check .......................................... 119
Calibration check menu
on EasyOne Air ......................................... 120

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

D EasyOne Flow Tube

overview .................................................... 27
Data EasyOne products ........................................... 44
adding a patient to the database on EasyOne Air EMR system .................................................... 44
............................................................. 83 custom plug-in ......................... 48, 49, 50, 51
adding patients to the database of direct-start workflow ................................... 50
EasyOne Connect ................................... 87 GDT plug-in ............................ 47, 50, 51, 114
backup ...................................................... 41 HL7 plug-in .............................. 47, 49, 50, 51
choosing test and adding patient ................ 55 initiating a spirometry test .......................... 50
choosing test and selecting existing patient 56 integration process .................................... 46
configuring the database .......................... 107 order workflow ........................................... 49
deleting a patient from the database on EasyOne overview .................................................... 45
Air ........................................................ 84 plug-ins, overview ................................ 45, 47
deleting patients from the database of EasyOne processing orders ................................ 46, 49
Connect ................................................ 88 sending test results .................................... 51
editing patient data in EasyOne Connect ...... 87 standards, supported ................................. 45
editing patient data on EasyOne Air ............. 84 workflow .............................................. 45, 49
exporting comprehensive data from XML file exchange plug-in ......... 48, 49, 50, 51
EasyOne Connect ................................... 92 End-of-test criteria, setting ...................... 99, 114
exporting data from EasyOne Air .................. 85 Environmental conditions, configuration ........ 118
exporting from EasyOne Connect to EasyWare .. Error messages ............................................. 123
93 Ethic correction, setting ......................... 100, 113
exporting logging information, EasyOne Connect Exporting data
........................................................... 124 comprehensive data from EasyOne Connect . 92
working with patient data ........................... 83 from EasyOne Air ........................................ 85
Database, see data from EasyOne Connect to EasyWare ............. 93
Default password .......................................... 106 logging information, EasyOne Connect ...... 124
Definitions, terms ........................................... 35 XML file, EasyOne Connect .......................... 92
Devices External devices, requirements for connection .. 15
Easy on-PC ............................................... 116
EasyOne Air ............................................. 116
EasyOne products ...................................... 44
F
external, requirements for connection .......... 15 Feedback, see quality messages
selecting a device .................................... 116 FEV6 option ............................................. 99, 114
settings ................................................... 116 Firmware ........................................................ 29
Direct-start workflow, EMR systems .................. 50 First-time setup ............................................... 17
Dirt, see cleaning Freezing, no reaction of EasyOne Air ........... 64, 89
Disinfecting, see cleaning FVC option .............................................. 99, 114
FVC tests .................................................. 36, 53
E performing breathing maneuver .................. 76
quality grades ............................................ 75
EasyOne Air spirometer, see system quality messages ....................................... 72
EasyOne Connect see also, tests
exporting comprehensive data .................... 92 FVL tests ......................................................... 36
exporting data to EasyWare ......................... 93 performing breathing maneuver .................. 77
exporting logging information ................... 124 quality grades ............................................ 75
exporting XML ............................................ 92 quality messages ....................................... 72
installing and updating .............................. 25 see also, tests
overview of features ................................... 33
printing reports .......................................... 90
processing orders ...................................... 49
G
sending test results to EMR system .............. 51 GDT plug-in ................................ 47, 50, 51, 114
system requirements ................................ 131 GOLD/Hardie interpretation algorithm ...... 95, 109
trend view .................................................. 91
working with patient data ........................... 83

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

H Menu
calibration check menu on EasyOne Air ...... 120
Hardware configuration menu in EasyOne Connect .... 105
devices .................................................... 116 history menu in EasyOne Connect ................ 34
overview .................................................... 26 history menu on EasyOne Air ....................... 86
Help ............................................................... 35 home screen on EasyOne Air ....................... 29
History menu main menu in EasyOne Connect ................... 34
in EasyOne Connect .................................... 34 more menu on EasyOne Air .......................... 29
on EasyOne Air ........................................... 86 orders menu in EasyOne Connect ................. 49
HL7 plug-in ................................... 47, 49, 50, 51 orders menu on EasyOne Air ........................ 29
Home screen on EasyOne Air ............................ 29 patients menu in EasyOne Connect .............. 34
Hygiene, see cleaning patients menu on EasyOne Air ..................... 29
reports menu on EasyOne Air ....................... 29
I settings menu on EasyOne Air ..................... 94
summary screen on EasyOne Air .................. 57
Icons .............................................................. 16
test menu in EasyOne Connect .................... 34
Infection, avoiding .......................................... 81
tools menu on EasyOne Air .......................... 29
Installing
utilities menu in EasyOne Connect ............... 34
EasyOne Connect ....................................... 25
Menu bar in EasyOne Connect .......................... 35
Instrument, see system
Messages
Intended use .................................................... 2
error, see troubleshooting
Interpretations
quality, see quality messages
GOLD/Hardie interpretation algorithm . 95, 109
More menu on EasyOne Air .............................. 29
NICE interpretation algorithm .............. 95, 109
Multiflow calibration check ............................ 115
NLHEP interpretation algorithm ........... 95, 109
MVV tests ....................................................... 36
system interpretation ......................... 95, 109
performing breathing maneuver .................. 79
Interval .......................................................... 35
see also, tests
Introduction ................................................... 26

L N
NICE interpretation algorithm ................... 95, 109
Language, setting the language ..................... 107
NLHEP interpretation algorithm ................ 95, 109
Layout editor, customizing reports’ layout ...... 116
LLN (lower limit of normal) ....................... 95, 109
Login .................................................... 105, 106 O
Logo ............................................................ 106 Operators, see users
Loss of EasyOne Pro/LAB ................................. 42 Order numbers, accessories ........................... 130
Orders
M definition ................................................... 35
menu in EasyOne Connect ........................... 49
Main menu in EasyOne Connect ....................... 34
menu on EasyOne Air .................................. 29
Manual Test Stop selection ............................ 108
order workflow, EMR systems ...................... 49
processing ................................................. 49
OSHA (Occupational Safety and Health
Administration) ............................................... 78
OSHA tests ..................................................... 78
quality grades ............................................ 75
see also, tests

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Overview Preparing patient for testing ............................ 53

breathing maneuvers .................................. 76 Printer
devices .................................................... 116 compatible printers .................................... 19
EasyOne Flow Tube respiratory tube ............. 27 configuration ........................................... 117
EMR plug-ins .............................................. 47 Printing
EMR system ............................................... 45 lung age on reports .................................. 115
features of EasyOne Connect ....................... 33 reports in EasyOne Connect ........................ 90
integration process, EMR system ................. 46 reports on EasyOne Air ................................ 86
plug-ins ..................................................... 45 Problems, see troubleshooting
spirometry workflow ................................... 52 Protocol
system ....................................................... 26 configuration for provocation tests ............ 116
user interface of EasyOne Air ....................... 29 definition ................................................... 35
user interface of EasyOne Connect ............... 34 Provocation tests
choosing a protocol .................................. 116
P definition ................................................... 35

Parameters
environmental conditions, configuration .... 118
Q
overview of tests parameters ....................... 36 Quality grades ................................................ 75
selecting parameters for test results .. 114, 115 Quality messages ........................................... 72
Password Quality, assessing quality of test .............. 95, 108
expiration .................................................. 40
policies ..................................................... 40 R
universal password .......................... 105, 106
user password .................................. 105, 106 Reaction, none, freezing of EasyOne Air ...... 64, 89
Patches .......................................................... 41 References, list of ......................................... 132
Patients Reports .......................................................... 83
adding a patient to the database on EasyOne Air configuration ........................................... 116
............................................................. 83 curve type for calibration check report ....... 115
adding patients to the database of customizing reports’ layout ....................... 116
EasyOne Connect ................................... 87 loading custom report layout ..................... 117
deleting a patient from the database on EasyOne printing in EasyOne Connect ....................... 90
Air ........................................................ 84 printing lung age on reports ...................... 115
deleting patients from the database of EasyOne printing on EasyOne Air .............................. 86
Connect ................................................ 88 Reported Graph, setting ............................ 115
editing patient data in EasyOne Connect ...... 87 selecting parameters for test results .. 114, 115
editing patient data on EasyOne Air ............. 84 viewing in EasyOne Connect ........................ 90
feedback, quality messages ........................ 72 viewing on EasyOne Air ............................... 86
instructing ................................................. 72 XML export settings .................................. 117
menu in EasyOne Connect ........................... 34 Reports menu on EasyOne Air .......................... 29
menu on EasyOne Air .................................. 29 Requirements
performing breathing maneuver .................. 76 connection to external devices .................... 15
preparing patient for testing ....................... 53 Results, see test results
reports ...................................................... 83
working with patient data ........................... 83 S
Performing spirometry ..................................... 52
Safety information .......................................... 11
Plug-ins for EMR systems
classification ............................................. 11
custom plug-in ......................... 48, 49, 50, 51
connection to external devices .................... 15
GDT plug-in ............................ 47, 50, 51, 114
equipment icons ........................................ 16
HL7 plug-in .............................. 47, 49, 50, 51
general safety information .......................... 11
XML file exchange plug-in ......... 48, 49, 50, 51
Scope of delivery ............................................ 17
Post
Security
about posts and bronchodilation ................. 55
breach ....................................................... 41
definition ................................................... 35
cyber ......................................................... 40
Predicted normal values .................................. 39
general guidelines ..................................... 43

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Servicing and troubleshooting ....................... 122 System

Setting up accessories, order numbers ...................... 130
physical components .................................. 20 checking for correct operation ................... 122
spirometer ................................................. 24 connecting physical components ................ 20
volume of calibration syringes ................... 115 identification and revision ............................ 2
Settings intended use ................................................ 2
devices .................................................... 116 interpretation algorithm ...................... 95, 109
end-of-test criteria .............................. 99, 114 overview .................................................... 26
ethic correction ................................ 100, 113 setting up .................................................. 24
language ................................................. 107 specifications .......................................... 125
menu on EasyOne Air .................................. 94 system settings ........................................ 107
predicted values ................................ 95, 109 System requirements for EasyOne Connect ..... 131
provocation tests ..................................... 116
spirometry, default settings ................ 95, 109 T
system settings ........................................ 107
see also, configuration Technician, user group .......................... 105, 106
Show % predicted column for post tests ......... 109 Test menu in EasyOne Connect ........................ 34
Show ratio parameter in % ............................. 109 Test results
Single Flow calibration check ......................... 115 comparing parameters over time ................. 91
Software comparing trials, setting ........................... 109
configuration ............................................. 94 displayed trials, setting ............................ 108
patches ..................................................... 41 end-of-test criteria ...................................... 72
update ....................................................... 41 entering comments .................................... 91
user interface of EasyOne Connect ............... 34 false diagnosis .......................................... 82
see also, EasyOne Connect interpretation algorithm ...................... 95, 109
Sources, published ....................................... 132 interpreting test results .............................. 71
Specifications ............................................... 125 predicted values ................................ 95, 109
Spirometer printing reports in EasyOne Connect ............ 90
setting up .................................................. 24 printing reports on EasyOne Air ................... 86
Spirometry quality grades ...................................... 54, 72
adding patient ........................................... 55 quality messages ................................. 54, 72
environmental conditions, configuration .... 118 reliable results ........................................... 54
explanation ............................................... 53 selecting test parameters ................. 114, 115
general workflow ........................................ 52 sending test results .................................... 51
performing, EasyOne Air stand-alone ........... 55 showing predicted values in a graph .......... 114
performing, EasyOne Connect and EasyOne Air .
64
selecting existing patient ............................ 56
settings ............................................. 95, 109
SSA tests
quality grades ............................................ 75
Status bar on EasyOne Air ................................ 32
Storage configuration .................................... 107
Summary screen on EasyOne Air ....................... 57
SVC tests ........................................................ 36
performing breathing maneuver .................. 80
quality grades ............................................ 75
quality messages ....................................... 72
see also, tests
Syringe volume, setting ................................. 115

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Tests Users
assessing quality of test ..................... 95, 108 access rights .................................... 105, 106
assessing tests retrospectively .................... 91 accounts .................................................. 107
breathing maneuvers .................................. 76 activating user handling ........................... 107
checking for correct operation ................... 122 administering user accounts ..................... 107
choosing test and adding patient ................ 55 Administrator, user group ................. 105, 106
choosing test and selecting existing patient 56 login ............................................... 105, 106
definition ................................................... 35 passwords ....................................... 105, 106
end-of-test criteria, setting .................. 99, 114 Technician, user group ..................... 105, 106
environmental conditions, configuration .... 118 Utilities menu in EasyOne Connect ................... 34
initiating a spirometry test .......................... 50
parameters available .................................. 36 V
performing a complete test with EasyOne Air
stand-alone ........................................... 58 Values
performing a complete test with interpretation algorithm ...................... 95, 109
EasyOne Connect and EasyOne Air .......... 65 predicted normal values ............................. 39
predicted normal values ............................. 39 settings ............................................. 95, 109
quality grades ...................................... 54, 75 showing predicted values in graph ............ 114
quality messages ................................. 54, 72
selecting manual test stop ........................ 108 W
Session complete message ......................... 54
Washing, see cleaning
tests available ........................................... 36
Website, ndd .................................................... 3
trials ......................................................... 54
see also, FVC tests, FVL tests, OSHA tests,
provocation tests, MVV test, SVC tests X
Theft of EasyOne Pro/LAB ................................ 42 XML exports
Tidal Breathing Required option ..................... 115 configuration ........................................... 117
Tools menu on EasyOne Air .............................. 29 overview, EasyOne Connect ......................... 92
Touchscreen, using ......................................... 28 XML file exchange plug-in .............. 48, 49, 50, 51
Trend view ...................................................... 91
Trials
Best Trial option ................................. 95, 108
Best Value option ............................... 95, 108
comparing trials, setting ........................... 109
definition ................................................... 35
marking as acceptable/unacceptable .......... 91
quality grades ...................................... 54, 75
quality messages ....................................... 72
selecting calibration check type ................ 115
Troubleshooting
checking for correct operation ................... 122
overview .................................................. 122
possible problems .................................... 123
solutions ................................................. 123

U
Updating
EasyOne Connect ....................................... 25
User interface
main menu ................................................. 49
overview EasyOne Air .................................. 29
overview EasyOne Connect .......................... 34
see also, software
see also,software

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

A Appendix

A.1 Electromagnetic Compatibility (EMC)

A.1.1 General

A.1.1.1 Environment
See:
 Intended use of the EasyOne Air spirometer, 2

A.1.1.2 EMC conformance

EasyOne Air is EMC-tested in conformity with the requirements of
IEC 60601-1-2:2007 3rd edition (see the following tables) and
IEC 60601-1-2:2014 4th edition (according clause 7 and 8.9, tables 4 to 9).
EasyOne Air is a medical device that requires special safety precautions and
must be installed and placed in operation in accordance with the information
given in tables below.

A.1.2 Safety information

See:
 Safety information regarding electromagnetic compatibility, 14

A.1.3 Compliant cables and accessories

WARNING
INCREASED EMISSIONS OR DECREASED IMMUNITY
The use of accessories, transducers and cables other than those specified
may result in increased emission or decreased immunity performance of the
equipment or system.
The table below lists cables, transducers, and other applicable accessories
with which the manufacturer claims EMC compliance.

Accessories that do not affect EMC compliance are not included in the
following list.

USB cable micro to type A, shielded, 1.8 m

USB cable micro to type B, shielded, 1.8 m
ndd power supply 5.0 V DC
 Accessories with which the manufacturer claims EMC compliance

 List of box contents, 17

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

A.1.4 Wireless module

EasyOne Air contains a wireless module for Bluetooth communication.

See Wireless connection in:
 List of specifications for EasyOne Air, 125

A.1.5 Electromagnetic emission

Guidance and manufacturer’s declaration – electromagnetic

emissions
EasyOne Air is intended for use in the electromagnetic environment specified
below. The user of EasyOne Air should assure that it is used in such an
environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions Group 1 EasyOne Air uses RF energy for its internal function. Additionally,
CISPR 11 the EUT contains a Radio Bluetooth, BLE and WLAN module, which
complies with the national regulations. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby
electronic equipment. However, a separation distance of 30 cm
shall be maintained.
RF emissions Class B EasyOne Air is suitable for use in all establishments, including
CISPR 11 domestic establishments and those directly connected to the
Harmonic emissions Class A public low-voltage power supply network that supplies buildings
IEC 61000-3-2 used for domestic purposes.

Voltage fluctuations/ Complies

flicker emissions
IEC 61000-3-3
 Emission table for IEC 60601-1-2 3rd and 4th edition

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

A.1.6 Electromagnetic immunity

The following tables are guidelines according to the 3rd edition of the
medical standard IEC 60601-1-2.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The EasyOne Air is intended for use in the electromagnetic environment
specified below. The user of EasyOne Air should assure that it is used in such
an environment.

Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge ±6 kV contact ±8 kV contact
(ESD) ±8 kV air ±15 kV air
IEC 61000-4-2
Electrical fast transient/ ±2 kV for power supply ±2 kV for power supply Mains power quality should be that of a
burst lines lines typical commercial or hospital
IEC 61000-4-4 ±1 kV for input/output environment.
lines
Surge ±1 kV line to line ±1 kV line to line Mains power quality should be that of a
IEC 61000-4-5 ±2 kV line to earth ±2 kV line to earth typical commercial or hospital
environment.
Voltage dips, short <5% UT (0.5 cycles) <5% UT (0.5 cycles) Mains power quality should be that of a
interruptions and voltage 40% UT (5 cycles) 40% UT (5 cycles) typical commercial or hospital
variations on power supply 70% UT (25 cycles) 70% UT (25 cycles) environment.
input lines
<5% UT for 5 s <5% UT for 5 s
IEC 61000-4-11
Note: UT is the AC mains voltage prior to application of the test level.
Power frequency 3 A/m 30 A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
 Electromagnetic immunity

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz equipment should be used no closer to
Radiated RF 3 V/m 10 V/m any part of the EasyOne Air, including
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.7 GHz cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.

Recommended separation distance:

d = 1.2 P
d = 0.35 P 80 MHz to 800 MHz
d = 0.7 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 survey,a should be
less than the compliance level in each
frequency range.b

Interference may occur in the vicinity of

equipment marked with the following
icon:

Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: 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 radios, amateur 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
EasyOne Air is used exceeds the applicable RF compliance level above, the EasyOne Air
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
EasyOne Air.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

 Electromagnetic immunity

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

Recommended separation distances between portable and mobile RF

communications equipment and EasyOne Air
EasyOne Air is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The user of EasyOne Air can help
prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters)
and EasyOne Air as recommended below, according to the maximum output
power of the communication equipment.

Rated maximum output

Separation distance according to frequency of transmitter
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.2 P d = 0.35 P d = 0.7 P

0.01 W 0.12 m 0.035 m 0.07 m
0.1 W 0.38 m 0.11 m 0.22 m
1W 1.2 m 0.35 m 0.70 m
10 W 3.8 m 1.1 m 2.2 m
100 W 12 m 3.5 m 7.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (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: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Note: An additional factor of 10/3 is used in calculating the recommended separation distance to decrease the
likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought
into patient areas.
 Recommended separation distances between portable and mobile RF communications equipment and EasyOne Air

Operator’s Manual • EasyOne Air • EasyOne Connect • V01

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