NDD EasyOne User manual

new diagnostic design
9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
EasyOne Air
Operator’s Manual V03

Preface
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 2/105 5
1. Preface
1.1. Revision history of the EasyOne Air Operator’s Manual
1.2. Identification and revision of the EasyOne Air spirometer
This revision V03 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 V1.13.0.
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
www.ndd.ch
For the USA: 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.
www.ndd.ch
For the USA: www.nddmed.com
Revision date Version Description
20 February 2020 V03 Revised version reflecting enhanced cybersecurity requirements
19 February 2019 V02 Updated content, alignment with the Operator’s Manuals of other EasyOne
products, includes exchanged CE mark due to the transition to a new notified
body in the EU
10 April 2018 V1.1 Revised version with minor changes
27 February 2017 V01 Initial release for market launch
Revision history of the EasyOne Air Operator’s Manual

Preface
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 3/105 5
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.
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.
www.ndd.ch
For the USA: www.nddmed.com

Preface
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 4/105 5
1.8. Legal information
For devices sold within the European Economic Area, any serious incident that
has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or
patient is established.
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.
Microsoft and Windows are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
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.
This Class B digital apparatus complies with Industry Canada RSS standards.
For the USA, see 47 Code of Federal Regulations Sec. 15.19(a)(3)
For Canada, see RSS-Gen — General Requirements for Compliance of Radio
Apparatus
1.10. Contact information
ndd Medizintechnik AG ndd Medical Technologies, Inc.
Technoparkstrasse 1 300 Brickstone Square, Suite 604
CH-8005 Zurich, Switzerland Andover, MA 01810, USA
Tel: [phone] Tel: [phone]
Fax: [phone] Fax: [phone]
www.ndd.ch www.nddmed.com

Preface
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 5/105 5
1.11. Product registration
Registering EasyOne Air facilitates the handling of warranty claims.
To register EasyOne Air, go to the ndd website.
www.ndd.ch
For the USA: www.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.

Table of contents
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 6/105 9
Table of contents
1. Preface 2
1.1. Revision history of the EasyOne Air Operator’s Manual . . . . . . . . . . . . 2
1.2. Identification and revision of the EasyOne Air spirometer . . . . . . . . . . 2
1.3. Version history of the EasyOne Connect PC software. . . . . . . . . . . . . . . 2
1.4. Intended use of the EasyOne Air spirometer . . . . . . . . . . . . . . . . . . . . . 3
1.5. Intended audience of this Operator’s Manual . . . . . . . . . . . . . . . . . . . . 3
1.6. Using this Operator’s Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.7. Application Notes for further information . . . . . . . . . . . . . . . . . . . . . . . 3
1.8. Legal information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.9. About electromagnetic interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.10. Contact information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.11. Product registration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.12. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Safety information 10
2.1. Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2. General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3. Safety information regarding electromagnetic compatibility . . . . . . . 13
2.4. About requirements for connections to external devices . . . . . . . . . . 14
2.5. List of equipment icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3. First-time setup 17
3.1. List of box contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.2. About compatible printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.3. Setting up the physical components . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.4. Setting up the EasyOne Air spirometer. . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5. Installing or updating the EasyOne Connect software on your PC . . . 24

Table of contents
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 7/105 9
4. Introduction 25
4.1. Introduction to the EasyOne Air spirometer . . . . . . . . . . . . . . . . . . . . . 25
4.1.1. Overview of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.1.2. Overview of the user interface of EasyOne Air. . . . . . . . . . . . . 27
4.2. Overview of features of the EasyOne Connect software. . . . . . . . . . . . 31
4.3. List of terms and definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.4. List of tests and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.5. List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.6. About sources for predicted normal values . . . . . . . . . . . . . . . . . . . . . 36
4.7. About connectivity and data exchange . . . . . . . . . . . . . . . . . . . . . . . . 36
5. Cybersecurity 37
5.1. About cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.2. About password policies and password expiration . . . . . . . . . . . . . . . 37
5.3. About periodical software updates and patches . . . . . . . . . . . . . . . . . 38
5.4. About backups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.5. Escalating in case of a security breach. . . . . . . . . . . . . . . . . . . . . . . . . 38
5.6. Dealing with a lost or stolen EasyOne Air or PC . . . . . . . . . . . . . . . . . . 39
5.7. Using EasyOne Air securely – general guidelines . . . . . . . . . . . . . . . . 39
6. Performing spirometry 41
6.1. Overview of the spirometry workflow . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.2. About preparation of spirometry and instructions for the patient . . . 42
6.3. About quality messages for trials and quality grades for tests. . . . . . 43
6.4. About posts and bronchodilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.5. Performing spirometry using EasyOne Air stand-alone . . . . . . . . . . . . 44
6.5.1. Choosing a test and adding a new patient . . . . . . . . . . . . . . . 44
6.5.2. Choosing a test and selecting an existing patient . . . . . . . . . 45
6.5.3. Performing a complete test using EasyOne Air stand-alone. . 46
6.6. Performing spirometry using EasyOne Connect in combination with
EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.6.1. Connecting EasyOne Air to EasyOne Connect . . . . . . . . . . . . . 52
6.6.2. Performing a bronchial provocation test using
EasyOne Connect in combination with EasyOne Air . . . . . . . . 53
6.7. About interpreting results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.8. List of quality messages and quality grades . . . . . . . . . . . . . . . . . . . . 55
6.8.1. About quality messages and quality grades . . . . . . . . . . . . . . 55
6.8.2. Quality messages for trials. . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.8.3. List of quality grades for tests . . . . . . . . . . . . . . . . . . . . . . . . . 56

Table of contents
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 8/105 9
7. Breathing maneuvers for all available tests 58
7.1. About breathing maneuvers for all available tests . . . . . . . . . . . . . . . 58
7.2. Performing the breathing maneuver for the FVC test. . . . . . . . . . . . . . 58
7.3. Performing the breathing maneuver for the FVL test . . . . . . . . . . . . . . 59
7.4. Performing the breathing maneuver for the MVV test . . . . . . . . . . . . . 60
7.5. Performing the breathing maneuver for the SVC test . . . . . . . . . . . . . 61
8. Hygiene and cleaning 62
8.1. Avoiding contamination while performing spirometry . . . . . . . . . . . . 62
8.2. List of cleaning solutions for EasyOne Air . . . . . . . . . . . . . . . . . . . . . . 63
9. Working with patient data and reports 64
9.1. Working with patient data and reports on EasyOne Air . . . . . . . . . . . . 64
9.1.1. Adding a patient to the database on EasyOne Air. . . . . . . . . . 64
9.1.2. Editing patient data on EasyOne Air . . . . . . . . . . . . . . . . . . . . 65
9.1.3. Deleting a patient from the database on EasyOne Air . . . . . . 65
9.1.4. Exporting data from EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . 66
9.1.5. Viewing and printing reports on EasyOne Air . . . . . . . . . . . . . 67
9.2. Working with patient data and reports in EasyOne Connect . . . . . . . . 68
9.2.1. Merging two patient data records with EasyOne Connect . . . 68
9.2.2. Copying patient data between EasyOne Air and
EasyOne Connect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
9.2.3. About the trend view with EasyOne Connect . . . . . . . . . . . . . . 70
9.2.4. Assessing tests retrospectively with EasyOne Connect . . . . . 71
10. Configuration 72
10.1. Configuration of EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
10.1.1. Configurations in the settings menu of EasyOne Air. . . . . . . . 72
Description of system settings of EasyOne Air . . . . . . . . . . . . 72
Description of spirometry settings of EasyOne Air . . . . . . . . . 73
Description of security settings of EasyOne Air . . . . . . . . . . . 77
Description of print settings of EasyOne Air . . . . . . . . . . . . . . 78
10.1.2. About performing a firmware update with EasyOne Air . . . . . 78
10.1.3. Performing a backup of EasyOne Air . . . . . . . . . . . . . . . . . . . . 79
10.1.4. About the information menu of EasyOne Air . . . . . . . . . . . . . . 80
10.1.5. About the user menu of EasyOne Air . . . . . . . . . . . . . . . . . . . . 81
10.2. Configuration of EasyOne Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
10.2.1. About user handling and the default password of
EasyOne Connect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
10.2.2. Activating user handling and administering user accounts. . 83

Table of contents
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
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11. Calibration check 84
11.1. Performing a calibration check with EasyOne Air . . . . . . . . . . . . . . . . 84
12. Servicing and troubleshooting 86
12.1. About charging the battery of EasyOne Air. . . . . . . . . . . . . . . . . . . . . . 86
12.2. Checking for correct operation of EasyOne Air. . . . . . . . . . . . . . . . . . . 86
12.3. List of troubleshooting solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
12.4. About reactivating EasyOne Air after storage. . . . . . . . . . . . . . . . . . . . 88
12.5. Exporting logging information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
13. Specifications and bibliography 89
13.1. List of specifications for EasyOne Air . . . . . . . . . . . . . . . . . . . . . . . . . . 89
13.2. List of specifications for the lithium-ion battery of EasyOne Air . . . . . 91
13.3. List of order numbers and accessories for EasyOne Air. . . . . . . . . . . . 93
13.4. List of system requirements for EasyOne Connect . . . . . . . . . . . . . . . . 93
13.5. List of bibliographic references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
14. Index 95
A. Appendix 99
A.1. Specific lung function tests for the USA . . . . . . . . . . . . . . . . . . . . . . . . 99
A.1.1. About the OSHA test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
A.1.2. About the SSA test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
A.2. Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . 100
A.2.1. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
EMC conformance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
A.2.2. Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
A.2.3. Compliant cables and accessories . . . . . . . . . . . . . . . . . . . . 101
A.2.4. Wireless module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
A.2.5. Electromagnetic emission . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
A.2.6. Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Safety information
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 10/105 16
2. Safety information
2.1. Classification
In this manual, safety information is classified as follows:
WARNING
WARNING . . .
. . . indicates a hazardous situation that, if not avoided, could result in death
or serious injury.
CAUTION
CAUTION . . .
. . . indicates a hazardous situation that, if not avoided, could result in minor
or moderate injury.
2.2. General safety information
Personnel
instruction
Make sure that all personnel are familiar with this Operator’s Manual and have
understood its content.
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
hazard
Inadequate qualification of personnel who operate EasyOne Air can put the
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-
contamination and
adverse reaction
After use, the disposable EasyOne FlowTube can be infectious.
Provide means for proper disposal of infectious waste, according to legal re-
quirements.