NDD easyone pro User manual

new diagnostic design
9000009_01
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
EasyOne Pro/LAB Rev. 05
Operator’s Manual V5.0

Preface
Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 2/171 4
1 Preface
1.1 Revision history of the EasyOne Pro/LAB Operator’s Manual
1.2 Identification and revision of the EasyOne Pro Respiratory
Analysis System
This revision V5.0 of the EasyOne Pro/LAB Operator’s Manual applies to
EasyOne Pro Respiratory Analysis Systems with a revision number greater
than Rev. 05.
If you are in doubt whether this revision of the Operator’s Manual applies to
your particular EasyOne Pro/LAB, 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 Pro/LAB firmware
A comprehensive version history of EasyOne Pro/LAB is available on the
ndd website. Simply search for “version history” on the ndd website.
On www.ndd.ch
For the US on www.nddmed.com
Revision Date Version Description
22 February 2017 V5.0 Newly created edition for major new hardware revision Rev. 05 of
EasyOne Pro/LAB
Revision history of the EasyOne Pro/LAB Operator’s Manual

Preface
Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 3/171 4
1.4 Intended use of the EasyOne Pro Respiratory Analysis System
EasyOne Pro/LAB is designed for conducting lung function measurements in
general or specialist practices or in hospitals.
EasyOne Pro/LAB can also be used outside of the laboratory when performing
lung function screenings or measurements in occupational medicine.
EasyOne Pro/LAB is used to conduct lung function measurements on adults
and children starting at age 4, except measurements of diffusing capacity of
the lung based on CO (DLCO), which can be performed on adults and children
starting at age 6.
1.5 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 Pro/LAB.
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

Preface
Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 4/171 4
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.
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.
1.9 Contact information
1.10 Product registration
Registering EasyOne Pro/LAB facilitates the handling of warranty claims.
To register EasyOne Pro/LAB, go to the ndd website.
http://reg.ndd.ch
For the US http://reg.nddmed.com
1.11 Disposal
ndd Medizintechnik AG ndd Medical Technologies
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
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 V5.0 • EasyOne Pro/LAB Rev. 05
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 5/171 9
Table of contents
1 Preface 2
Revision history of the EasyOne Pro/LAB Operator’s Manual . . . . . . . . . . . . . 2
Identification and revision of the EasyOne Pro Respiratory Analysis System 2
Version history of the EasyOne Pro/LAB firmware . . . . . . . . . . . . . . . . . . . . . . 2
Intended use of the EasyOne Pro Respiratory Analysis System . . . . . . . . . . . 3
Intended audience of this Operator’s Manual . . . . . . . . . . . . . . . . . . . . . . . . . 3
Using this Operator’s Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Application Notes for further information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Legal information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contact information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Product registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 Safety information 10
Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Safety information regarding electromagnetic compatibility . . . . . . . . . . . . 12
About requirements for connections to external devices . . . . . . . . . . . . . . . 13
List of applied parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
List of equipment icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3 Introduction 15
About the two products EasyOne Pro and EasyOne Pro LAB . . . . . . . . . . . . . 15
Introduction to the EasyOne Pro Respiratory Analysis System . . . . . . . . . . . 16
Overview of EasyOne Pro Respiratory Analysis System. . . . . . . . . . . . . 16
About compatible printers and printer setup. . . . . . . . . . . . . . . . . . . . . 20
Connecting the components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Turning EasyOne Pro/LAB on and off . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
About using the touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Overview of the user interface of EasyOne Pro/LAB . . . . . . . . . . . . . . . 27
List of terms and definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
List of tests and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
About sources for predicted normal values . . . . . . . . . . . . . . . . . . . . . . . . . . 35

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4 Cybersecurity 36
About cybersecurity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
About password policies and password expiration. . . . . . . . . . . . . . . . . . . . 36
About periodical software updates and patches. . . . . . . . . . . . . . . . . . . . . . 37
About backups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Escalating in case of a security breach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Dealing with a lost or stolen EasyOne Pro/LAB . . . . . . . . . . . . . . . . . . . . . . . 38
Using EasyOne Pro/LAB securely – general guidelines. . . . . . . . . . . . . . . . . 39
5 Connectivity and data exchange 40
About connectivity between EasyOne products. . . . . . . . . . . . . . . . . . . . . . . 40
About integration of EMR systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
About supported EMR standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
About possible workflows with your EMR system . . . . . . . . . . . . . . . . . 41
Overview of the integration process. . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Overview of the plug-ins for EMR systems . . . . . . . . . . . . . . . . . . . . . . . 43
About the HL7 plug-in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
About the GDT plug-in. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
About the XML file exchange plug-in . . . . . . . . . . . . . . . . . . . . . . . 44
About custom plug-ins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Working with your EMR system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Processing orders from your EMR system . . . . . . . . . . . . . . . . . . . 45
Initiating a spirometry test with the direct-start workflow . . . . . . 46
Sending individual test results to your EMR system . . . . . . . . . . . 47

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6 Performing lung function tests 48
Overview of the spirometry workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
About preparation of spirometry and instructions for the patient . . . . . . . . 49
About quality messages for trials and quality grades for tests . . . . . . . . . . 50
About posts and bronchodilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Performing basic spirometry without gas supply . . . . . . . . . . . . . . . . . . . . . 51
Performing a complete test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Performing a bronchial provocation test . . . . . . . . . . . . . . . . . . . . . . . . 58
Performing lung function tests with gas supply . . . . . . . . . . . . . . . . . . . . . . 65
Mounting the motor and valve unit onto the flow sensor . . . . . . . . . . . 65
Dismount the motor and valve unit from the flow sensor . . . . . . . . . . . 66
Connecting the gas supply and opening the gas valves. . . . . . . . . . . . 66
Contraindications for a DLCO test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Performing a DLCO test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Performing an MBW test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Closing the gas valves and disconnecting the gas supply . . . . . . . . . . 84
About interpreting results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
List of quality messages and quality grades . . . . . . . . . . . . . . . . . . . . . . . . . 86
About quality messages and quality grades . . . . . . . . . . . . . . . . . . . . . 86
List of quality messages for trials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
List of quality grades for tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
7 Breathing maneuvers for all available tests 94
About breathing maneuvers for all available tests . . . . . . . . . . . . . . . . . . . . 94
Performing the breathing maneuver for the FVC test. . . . . . . . . . . . . . . . . . . 94
Performing the breathing maneuver for the FVL test. . . . . . . . . . . . . . . . . . . 95
Performing the breathing maneuver for the MVV test . . . . . . . . . . . . . . . . . . 96
Performing the breathing maneuver for the SVC test . . . . . . . . . . . . . . . . . . 97
8 Hygiene and cleaning 98
Avoiding contamination while performing spirometry . . . . . . . . . . . . . . . . . 98
Cleaning instructions for EasyOne Pro/LAB . . . . . . . . . . . . . . . . . . . . . . . . . . 99

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9 Working with patient data and reports 100
Adding patient data to the database of EasyOne Pro/LAB . . . . . . . . . . . . . 100
Editing patient data with EasyOne Pro/LAB . . . . . . . . . . . . . . . . . . . . . . . . . 100
Merging two patient data records with EasyOne Pro/LAB. . . . . . . . . . . . . . 101
Deleting patient data from the database of EasyOne Pro/LAB . . . . . . . . . . 101
Viewing and printing reports with EasyOne Pro/LAB. . . . . . . . . . . . . . . . . . 102
About the trend view with EasyOne Pro/LAB . . . . . . . . . . . . . . . . . . . . . . . . 102
Assessing tests retrospectively and entering comments with EasyOne Pro/LAB
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
About exporting comprehensive data from EasyOne Pro/LAB . . . . . . . . . . 104
About exporting XML from EasyOne Pro/LAB . . . . . . . . . . . . . . . . . . . . . . . . 104
10 Configuration 105
About saving or discarding configuration changes of EasyOne Pro/LAB. . 105
About user handling and the default password. . . . . . . . . . . . . . . . . . . . . . 105
Description of general configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Utilities > Configuration > General > Header . . . . . . . . . . . . . . . . . . . . 106
Utilities > Configuration > General > Storage . . . . . . . . . . . . . . . . . . . 106
Utilities > Configuration > General > System Settings . . . . . . . . . . . . 107
Activating user handling and administering user accounts . . . . . . . . 107
Description of test configurations for EasyOne Pro/LAB. . . . . . . . . . . . . . . 108
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 > DLCO . . . . . . . . . . . . . . . . . . . . . . . . 115
Utilities > Configuration > Test > FRC (MBW). . . . . . . . . . . . . . . . . . . . 116
Utilities > Configuration > Test > CalCheck . . . . . . . . . . . . . . . . . . . . . 117
Utilities > Configuration > Test > Provocation . . . . . . . . . . . . . . . . . . . 117
Loading and selecting a custom report layout of EasyOne Pro/LAB. . . . . . 118
Description of printer configurations of EasyOne Pro/LAB . . . . . . . . . . . . . 118
Description of environment configurations . . . . . . . . . . . . . . . . . . . . . . . . . 119
Performing a software update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

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11 Calibration check 122
Performing a calibration check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Performing biological quality control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
About biological quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Performing and assessing biological quality control . . . . . . . . . . . . . 125
List of quality criteria for biological quality control. . . . . . . . . . . . . . . 126
About a DLCO calibration check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
About an MBW calibration check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
12 Servicing and troubleshooting 127
Checking for correct operation of EasyOne Pro/LAB . . . . . . . . . . . . . . . . . . 127
List of troubleshooting solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
About reactivating EasyOne Pro/LAB after storage . . . . . . . . . . . . . . . . . . . 128
Exporting logging information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Creating screenshots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
13 Specifications and bibliography 130
List of specifications for EasyOne Pro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
List of specifications for EasyOne Pro LAB . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Description of test gas requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
List of order numbers and accessories for EasyOne Pro/LAB . . . . . . . . . . . 136
List of bibliographic references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
14 Index 138
A Appendix 143
List of used tools and frameworks in the EasyOne Pro/LAB software. . . . . 143
Microsoft Software License Agreement for Windows Embedded 8 Standard . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
GNU General Public License Version 3, 29 June 2007 for Sumatra PDF Reader.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
EMC conformance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Compliant cables and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Wireless module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Electromagnetic emission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Safety information
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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 To avoid risk of electric shock, this equipment must only be connected to a
grounded mains supply.
Do not position EasyOne Pro/LAB in a way that makes it difficult to operate the
disconnection device.
Patient health
hazard and false
diagnosis
Use only medical grade gases.
Electric shock Patients and technicians may be exposed to dangerous voltage.
To ensure electric safety connect only equipment, such as printers and net-
works, that complies with the IEC/EN 60950-1 standard and/or the IEC/
EN 60601-1 standard for electrical safety.
Use only power cables approved by or acceptable to the authorities in your
country.
Cross-
contamination and
damage to the
environment
After use, the disposable spirette can be infectious or can be contaminated
with allergens, irritants, or otherwise toxic substances.
The used spirette can cause damage to the environment.
Provide means for proper disposal of infectious waste, according to legal re-
quirements.
Fire The plastic case can catch fire and cause burn injuries to the patient.
The instrument is not suitable for use in the presence of flammable gases,
such as anesthetic agents.