NDD easyone pro User manual

new diagnostic design

9000009_01

EasyOne Pro/LAB Rev. 05

Operator’s Manual V5.0

Preface

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

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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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

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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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

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1.8 Legal information

Due to continuing product innovation, specifications in this manual are

subject to change without notice.

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.

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

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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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

14

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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

35

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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

35

 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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

35

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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

35

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

Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05

35

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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