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
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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
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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
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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: +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
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.
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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.
Safety information
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Electric shock or
hot surfaces
Do not unscrew and open EasyOne Pro/LAB or any parts of it.
Cross-
contamination
Tuberculosis or other diseases spread by droplet nuclei and can cause aerosol
infection.
Proper attention to environmental engineering controls, such as ventilation,
air filtration or ultraviolet decontamination of air, must be used.
Patient health
hazard and device
malfunction
For spirometry tests with gas supply, off-specification test gas can cause ad-
verse reaction, poisoning, allergic reaction, or other harm to the patient.
Also, off-specification test gas can cause device malfunction.
Use only appropriate gas, according to the test gas requirements.
Description of test gas requirements, 136
False diagnosis For unforeseen reasons, malfunction of EasyOne Pro/LAB can lead to false re-
sults and false diagnosis.
Perform calibration checks periodically.
Calibration check, 122
Checking for correct operation of EasyOne Pro/LAB, 127
False diagnosis EasyOne Pro/LAB can be damaged when dropped or during transport.
Do an incoming inspection when you first receive EasyOne Pro/LAB. If you de-
tect a damage, contact your EasyOne dealer or the ndd Servicing Department.
Do not drop EasyOne Pro/LAB.
If EasyOne Pro/LAB has been dropped, check for correct operation of
EasyOne Pro/LAB.
Checking for correct operation of EasyOne Pro/LAB, 127
Patient health
hazard and
false diagnosis
Inadequate qualification of the personnel can put the patient’s health at risk
and can result in incorrect execution of tests, false results, and false diagnosis
and/or high costs.
EasyOne Pro/LAB must only be used by qualified personnel.
Intended audience of this Operator’s Manual, 3
False diagnosis Setup with wrong environment data can cause false results and false diagno-
sis.
Verify the set up environment data.
Description of environment configurations, 119
Failed update and
data loss
An update may fail.
For various other reasons, data loss can occur and is generally unforeseen.
Perform backups of the database of EasyOne Pro/LAB frequently.
About exporting comprehensive data from EasyOne Pro/LAB, 104
Malfunction Non-original accessories, like tubes or cables can cause malfunction.
Only use original accessories by ndd.
List of order numbers and accessories for EasyOne Pro/LAB, 136
Safety information
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False diagnosis Non-original respiratory tubes can cause measurement error and false results.
You must only use spirette respiratory tubes by the manufacturer ndd to assure
accuracy, long-life, and full warranty coverage.
List of order numbers and accessories for EasyOne Pro/LAB, 136
Network connection Connection of EasyOne Pro/LAB 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.
Patient health
hazard and false
diagnosis
EasyOne Pro/LAB measures and presents data reflecting a patient’s physio-
logical condition. When reviewed by a qualified physician or clinician, this
data can be useful in determining a diagnosis. However, the data should not
be used as sole means for determining a patient’s diagnosis.
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 Pro/LAB.
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 Pro/LAB.
Keep a distance of at least 30 cm (12 inches) to any part of EasyOne Pro/LAB.
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 Pro/LAB.
Proximity to other
equipment
EasyOne Pro/LAB should not be used adjacent to or stacked with other equip-
ment.
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.
See Appendix
Safety information
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2.4 About requirements for connections to external devices
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.
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.
Safety information
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2.5 List of applied parts
Applied parts are those parts of medical electrical equipment that necessarily
come into physical contact with the patient to perform the intended use of the
device.
The following part of EasyOne Pro/LAB is an applied part:
• Flow sensor
Overview of EasyOne Pro Respiratory Analysis System, 16
2.6 List of equipment icons
Read usage instructions.
Caution
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.
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 connecting devices and data
transfer, applies to cables and connectors
®
Introduction
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35
3 Introduction
3.1 About the two products EasyOne Pro and EasyOne Pro LAB
In the product family EasyOne Pro Respiratory Analysis System, there are two
products, EasyOne Pro and EasyOne Pro LAB. EasyOne Pro LAB has the same
functionality as EasyOne Pro, but in addition to that can perform the multi-
breath washout test (MBW test) to determine the functional residual capacity
(FRC).
This Operator’s Manual is for both products, EasyOne Pro and
EasyOne Pro LAB. Therefore, both products are commonly referred to as
EasyOne Pro/LAB in this Operator’s Manual.
Introduction
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3.2 Introduction to the EasyOne Pro Respiratory Analysis System
3.2.1 Overview of EasyOne Pro Respiratory Analysis System
The EasyOne Pro/LAB respiratory analysis system
The EasyOne Pro Respiratory Analysis System
A Patient tube B Flow sensor cable
C Flow sensor D Motor and valve unit
E spirette respiratory tube F Flow sensor holder
G Power button H Touchscreen
B EA GFC D H
Introduction
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Ports and connectors of EasyOne Pro/LAB
I 2x USB ports J 2x network ports (Ethernet)
K Slot for USB flash drive L Slot for inserting the flow sensor holder
M Monitor port (HDMI) N Monitor port (VGA/D-Sub)
O Connector for the temperature and humidity sensor P Filter pack
Q Port for the DLCO gas tube R Potential equalization pin
S Power port T Mains switch
U Port for the O
2
gas tube (for MBW
tests, EasyOne Pro LAB only)
V Connector for the flow sensor cable
W Connector for the patient tube
V
J
NM S T W
K
QP RUO
LI
Introduction
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The one-way valve for multi-patient use
The one-way valve ensures that DLCO gas or O
2
gas only flows in one
direction. The one-way valve can be used for multiple patients and must be
replaced once a year.
The one-way valve is designed to work accurately with EasyOne Pro/LAB. For
reliable results, use only the original one-way valve manufactured by ndd.
The figure shows how to insert the one-way valve.
Attaching the one-way valve
Introduction
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The DLCO barriette and FRC barriette for single-patient use
The DLCO barriette and the FRC barriette connect the spirette respiratory tube
to gas system. To ensure hygienic testing, the DLCO barriette and the FRC
barriette are disposables for single-patient use.
The DLCO barriette and the FRC barriette are designed to work accurately with
EasyOne Pro/LAB. For reliable results, use only the original DLCO barriette
and the original FRC barriette manufactured by ndd.
The figures show how to insert the DLCO barriette and the FRC barriette.
Inserting the DLCO barriette
Inserting the FRC barriette
Introduction
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The spirette respiratory tube for single-patient use
The spirette respiratory tube
To ensure hygienic testing, the spirette respiratory tube is a disposable for
single-patient use. The spirette is designed to work accurately with the
ultrasonic sensor of EasyOne Pro/LAB. For reliable results, use only the
original ndd spirette.
CAUTION
FALSE DIAGNOSIS
Non-original respiratory tubes can cause measurement error and false results.
You must only use spirette respiratory tubes by the manufacturer ndd to assure
accuracy, long-life, and full warranty coverage.
List of order numbers and accessories for EasyOne Pro/LAB, 136
3.2.2 About compatible printers and printer setup
Printers can be connected directly via USB, or printers can be shared and
accessed over the network.
Refer to the Application Notes below for recommended printers and printer
setup.
Application Note Recommended Printers for EasyOne Pro
Application Note Using Printers with EasyOne Pro
Application Notes for further information, 3
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