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
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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.

Safety information
Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 11/105 16
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.
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 5
List of order numbers and accessories for EasyOne Air 93
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 distribution partner or the
ndd Servicing Department.
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 86
Fire due to explosive
or flammable gases
If used in the vicinity of flammable gases, the plastic case may catch fire and
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 23
List of specifications for EasyOne Air 89
Configuration of EasyOne Air 72
List of specifications for EasyOne Air 89
About reactivating EasyOne Air after storage 88
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.

Safety information
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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.
List of quality messages and quality grades 55
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 79
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 79
False diagnosis For unforeseen reasons, malfunction of EasyOne Air can lead to false results
and false diagnosis.
Perform calibration checks periodically.
Calibration check 84
Checking for correct operation of EasyOne Air 86
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
and explosion
Do not connect the battery improperly.
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 86
Disposal 5
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.

Safety information
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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 93
False diagnosis Non-original respiratory tubes can cause measurement error and false results.
You must only use EasyOne FlowTube respiratory tubes by the manufacturer
ndd to assure accuracy, long-life, and full warranty coverage.
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
surgical equipment
Electrical devices with a high RF power output during intended use (e.g. High
frequency (HF) surgical equipment) should not be operated in parallel with
EasyOne Air.
Portable wireless
communications
equipment
Portable wireless communications equipment such as wireless home network
devices, mobile phones, cordless telephones and their base stations, walkie-
talkies, etc. can affect EasyOne Air.
Keep a distance of at least 30 cm (12 in) to any part of EasyOne Air.
Increased emissions
or decreased
immunity
Accessories, transducers, and cables other than those specified by the manu-
facturer or replacement parts for internal components may result in increased
emissions or decreased immunity of EasyOne Air.
Proximity to other
equipment
EasyOne Air should not be used adjacent to or stacked with other 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.

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Interruption of the
USB connection
Electrical fast transient coupling to the USB cable or electrostatic discharge on
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.
See Appendix
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.

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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
Read usage instructions
Follow instructions for use
Do not reuse, i.e., single-patient use (applicable to the
EasyOne FlowTube)
CE mark including Notified Body Identification Number
Compliance with additional US and Canadian safety requirements
for medical electrical equipment
Medical electric equipment that includes a radio frequency
transmitter and emits non-ionizing radiation
Manufacturer
Date of manufacture
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
Class II equipment
For indoor use only

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Universal Serial Bus (USB 1.0/1.1, USB 2.0, max. 100 mA)—
standard for data transfer, connecting devices, and battery
charging, applies to cables and connectors
Connection to PC or printer
Battery
Battery door open position
Power ON/OFF (standby mode)
Connection to power supply
Fragile—handle with care
Do not use if package is damaged
Keep dry
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Serial number
Batch code
Catalog number
Medical Device
Authorized representative in the European Community
MD

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3. First-time setup
3.1. List of box contents
The box contains the following items:
Box contents – top inlay
A EasyOne FlowTube respiratory tubes B EasyOne Air spirometer
A
B

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Box contents – bottom inlay
A Battery B USB Bluetooth adapter
C USB flash drive D 2x USB cable
E Nose clip F ndd power supply
G Cradle
A
B
C
D
F
G
E

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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 78
Setting up the physical components 20
Application Note Printer Compatibility List
Application Notes for further information 3
A USB cable micro to type A B USB cable micro to type B
B
A

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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.
1Unlock and open the battery compartment by turning the lock screw
clockwise.
2Insert the battery into the battery compartment of EasyOne Air.