NDD easyone pro, easyone pro lab Operator's Manual

EasyOne Pro™ EasyOne Pro™ LAB

Operator's Manual

Version V04b

Note

The information in this manual only applies to software version V1.5.x.x. It does not apply to earlier software versions.

Due to continuing product innovation, specifications in this manual are subject to change without notice.

ndd™, the ndd logo™, EasyOne Pro™, barriette™ and spirette™ are trademarks owned by ndd Medizintechnik AG.

This manual describes the product EasyOne Pro™ and its variant EasyOne Pro™ LAB. The safety information and all operating instructions apply to both devices. Safety information and operating instructions that apply only to EasyOne Pro™ LAB are accompanied by the symbol shown at left and by the word LAB.

ndd Medizintechnik AG Technoparkstrasse 1 CH-8005 Zürich, Switzerland Tel: +41(44) 445 2530 Fax: +41(44) 445 2531

www.ndd.ch

2 EasyOne Pro™ / EasyOne Pro™ LAB

ndd Medical Technologies 2 Dundee Park Andover, MA 01810, USA Tel: 1 978 470 0923 Fax: 1 978 470 0924

www.nddmed.com

Contents

1 Introduction 5

1.1 CE Marking Information 5

1.2 Revision History 6

1.3 Manual Purpose 6

1.4 Intended Audience 6

1.5 Styles 6

1.6 Safety Information 6

1.7 Intended Use 15

1.8 Contraindications to Performing DLCO Tests 15

1.9 Additional Functions of EasyOne Pro™ LAB 15

1.10 Components and Functional Description of EasyOne Pro™ 16

1.11 EasyOne Pro™ Flow Sensor Design and Operation 17

1.12 Test Gas Requirements 18

2 Start-up and Initial Preparation 20

2.1 Unpacking, Environmental Conditions 20

2.2 Equipment Description 21

2.3 Preparing the Device 23

2.4 Gas Supply 26

2.5 Connecting the Keyboard and the Mouse 31

2.6 Connecting the Printer 31

2.7 Power 33

2.8 Inserting the One-Way Valve, DLCO barriette™/ FRC barriette™ and spirette™ 35

2.9 Switching the Device On, Functional Test 38

3 Performing a Test 41

3.1 Selecting/Adding a Patient 41

3.2 Selecting a Test 45

3.3 Forced Vital Capacity (FVC/FVL) 46

3.4 Vital Capacity (SVC) 56

3.5 Maximum Voluntary Ventilation (MVV) 58

3.6 Bronchial Provocation 60

3.7 Quick Test 66

3.8 CO Diffusing Capacity (DLCO) 67

3.9 FRC Test (EasyOne Pro™ LAB only) 71

3.10 Ending the Test 75

3.11 Retrieving/Printing Stored Tests 75

3.12 Trend View 78

3.13 Definition of Important Parameters 80

4 Editing Patient Data 83

EasyOne Pro™ / EasyOne Pro™ LAB 3

Contents

5 Quality Messages and Quality Grades 84

5.1 FVC/FVL Quality Messages and Quality Grades 84

5.2 SVC Quality Messages and Quality Grades 87

5.3 DLCO Quality Messages and Quality Grades 88

5.4 FRC Quality Messages 93

5.5 System Interpretation 96

5.6 Retrospective Test Assessment, Entering Comments 97

6 Switching the Device Off 99

7 Hygiene, Cleaning, Maintenance, Disposal 100

8 System Settings 110

9 Troubleshooting Tips 130

10 Specifications 131

11 Order Information 134

12 Appendix 135

12.1 Interpretation 135

12.2 Predicted Values 139

12.3 GDT Interface 140

12.4 Introduction to Adjustment of DLCO Measurements 146

12.5 How to interpret TLC from a single breath maneuver 148

12.6 Report Designer 150

12.7 Electromagnetic Compatibility (EMC) 154

12.8 Microsoft Software License Terms for Windows® XP Embedded Runtime 158

12.9 Quick Reference Guide to the Screen Displays 164

12.10 EasyOne Pro LAB Washout Moment Analysis 180

12.11 Literature 182

4 EasyOne Pro™ / EasyOne Pro™ LAB

1Introduction

1.1 CE Marking Information

 The product EasyOne Pro™ bears the CE marking CE-120 (notified body

SGS) indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive.

 The flow sensor has been assigned to class IIa as specified in Annex IX of

the Directive 93/42/EEC.

 The device fulfills the requirements of standard EN 60601-1 "Medical

electrical equipment, Part 1: General requirements for basic safety and essential performance" as well as the electromagnetic immunity requirements of standard EN 60601-1-2 "Electromagnetic compatibility – Medical electrical equipment".

 The radio-interference emitted by EasyOne Pro™ is within the limits

specified in EN 55011, class B.

 The CE marking covers only the accessories listed in the Order

Information chapter.

 Magnetic and electrical fields are capable of interfering with the proper

performance of the device. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems, and cellular telephones are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the equipment away from these devices and verify its performance before use.

 The device is suitable for continuous operation.

 The product fulfills the requirements of the following standards:

 EN ISO 14971  IEC60601-1: 2005  EN 60601-1: 2006  EN 60601-1-2: 2007  EN 60601-1-6: 2007

 The country of manufacture is indicated on the device label.

Introduction

EasyOne Pro™ / EasyOne Pro™ LAB 5

1.2 Revision History

Edition Date Comment

Version V01.01 2008-07-22 Initial Release

Version V01.02 2009-11-23 Revised Edition

Version V02 2010-04-06 Revised Edition

Version V03 2011-11-29 Revised Edition

Version V03A 2012-01-27 Revised Edition

Version V03B 2012-05-23 Revised Edition

Version V03C 2012-08-23 Revised Edition

Version V04 2012-11-26 Revised Edition

Version V04b 2012-11-30 Revised Edition

1.3 Manual Purpose

This manual contains the instructions necessary to employ the product safely and in accordance with its function and intended use.

Introduction

1.4 Intended Audience

This manual is geared for clinical professionals. Clinical professionals are expected to have working knowledge of medical procedures, practices, and terminology as required for completing these examinations.

1.5 Styles

Keys (softkeys and hardware elements) are represented in bold print, e.g. New Patient, Select Patient.

Terms appearing on the display and product names are italicized, e.g. Last Name, First Name, EasyOne Pro™.

1.6 Safety Information

General Information

 This manual is an integral part of the device. It should be available to the

equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety. Please note

6 EasyOne Pro™ / EasyOne Pro™ LAB

Introduction

that information pertinent to several chapters is given only once. Therefore, read the manual once in its entirety.

 To ensure patient safety, the specified measuring accuracy, and

interference-free operation, we recommend using only original accessories available through ndd. The user is responsible if using nonndd accessories.

 ndd is responsible for the effects on safety, reliability, and performance

of the device, only if

 assembly operations, extensions, readjustments, modifications, or

repairs are carried out by ndd or by ndd-authorized personnel

 the device is used in accordance with the instructions given in this

manual.

 The warranty does not cover damage resulting from the use of unsuitable

accessories and consumables from other manufacturers.

 Always consult with ndd, if you intend to connect equipment not

mentioned in this manual.

 Components and accessories must comply with the applicable IEC

60601 safety standards and/or the configured system must comply with the collateral standard IEC 60601-1-1 "Requirements for the safety of medical electrical systems".

 The power cord must be an approved type acceptable to the authorities

in the country where the equipment is used.

 EasyOne Pro™ must not be exposed to low temperatures during storage

and transport to avoid moisture condensation at the application site. Wait until all moisture has vaporized before using the device. Allow the device to reach room temperature before using it.

 All publications are in conformity with the device specifications and

standards on safety of electromedical equipment valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual.

 The illustrations in this manual are only examples. They are not binding

in any way.

 No part of this manual may be reproduced without written permission

from ndd.

EasyOne Pro™ / EasyOne Pro™ LAB 7

Definitions

In this manual the safety information is classified as follows:

Safety Notices

Introduction

Danger

indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.

Warning

indicates a hazard. If not avoided, the hazard can result in death or serious injury.

Caution

indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/property damage.

Danger

Explosion Hazard—EasyOne Pro™ is not designed for use in areas of medical locations where an explosion hazard may exist. Explosion hazards may result from the use of flammable anesthetics, skin cleansing agents or disinfectants. Great care must be exercised when the system is used in an oxygen-enriched atmosphere. The atmosphere is considered to be oxygen-enriched when the room air contains more than 25% of oxygen or nitrous oxide.

8 EasyOne Pro™ / EasyOne Pro™ LAB

Introduction

Warning

Shock Hazard—

 Before using the system, make sure that it is in correct

working order and operating condition. Check the cables and connectors, in particular, for signs of damage. Replace damaged cables and connectors immediately, before use.

 Do not expose EasyOne Pro™ to direct sunlight to

prevent system components from reaching inadmissible, high temperatures. Furthermore, EasyOne Pro™ has no additional protection against the ingress of humidity.

 When disconnecting the device from the power line,

remove the plug from the wall outlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the sockets of the power cord.

 Do not use multiple portable socket outlets (MPSO) to

connect the devices to the power line.

 Printers operated in the patient vicinity must meet the

requirements of IEC 60601. If they do not, they must be modified and be connected to earth ground (PE, potential equalization).

 All devices of a system must be connected to the same

power supply circuit. Devices that are not connected to the same circuit must be electrically isolated when operated, e.g., with an isolated RS232 interface (this is not a requirement in the USA).

 Devices may be connected to other devices or to parts of

systems only when it has been made certain that there is no danger to the patient, the operators, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected equipment, the user must contact the manufacturers concerned or other informed experts to find out whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of equipment. Standards IEC 60601-1-1/ EN60601-1-1 must be complied with in all cases.

EasyOne Pro™ / EasyOne Pro™ LAB 9

Introduction

 Liquids must not be allowed to enter the device or the

sensor. Devices and sensors into which liquids have penetrated must be immediately cleaned and checked by a service technician, before they can be reused.

 Do not open the device or the sensor. There are no user-

replaceable components inside the device or the sensor.

 Do not insert objects of any kind into the device. They

may touch live components and you might suffer an electric shock, cause fire, or damage the device.

Warning

Patient Hazard—The operator must be trained in the use of the device.

Patient Hazard—Before performing any tests on patients, refer to the ATS/ERS Taskforce recommendations (literature [11] ("Literature" on page 182).

Patient Hazard—Custom configured reports bear the label Custom Report at the bottom of each page. The user is responsible for the content and use of all custom configured reports.

Patient Hazard—Do not touch the accessible contacts of connectors located at the rear panel and the patient at the same time.

Patient Hazard, Equipment Damage—Do not modify EasyOne Pro™ in any way.

Patient Hazard—When used at 230-240 V, 60 Hz equipment must be connected to a center-tapped 240 V single phase transformer (US requirement).

Risk of Infection—Follow all cleaning procedures carefully, and thoroughly inspect the components after they are cleaned and before each patient is tested. Cleaning residue, particulate matter, and other contaminates (including pieces of torn or broken components) in the breathing circuit create a safety risk to the patient during test procedures. Aspiration of contaminates can be potentially life-threatening.

Risk of Infection—Proper use of the spirette™ and the DLCO barriette™/FRC barriette™ provides a reliable infection barrier. The use of other accessories is not permitted.

Cross Contamination Between Patients—The spirette™ and the DLCO barriette™/FRC barriette™ are intended for

10 EasyOne Pro™ / EasyOne Pro™ LAB

Introduction

single patient use. Use a new one for each patient to prevent cross contamination between patients.

Risk of Poisoning—Observe all information provided by the manufacturers of chemical products required for the use and care of the product. Always keep these chemical products in their original containers to avoid any confusion which may have severe consequences.

RF Interference—Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of this device. Check the device performance before each use.

Risk to Persons—If the display is broken, avoid contact with the liquid crystal.

Suffocation Hazard—Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packaging material out of children's reach.

Danger

Patient hazard — Observe the following points when performing bronchial provocation tests:

 Bronchial provocation tests can be dangerous for

patients! A primary condition for safe provocation test procedures is a trained and experienced physician.

 Above all, these physicians must be familiar with

appropriate precautions and guidelines, warnings, procedures, contraindications, when to stop further testing, etc. as defined in the medication documentation and in the standards.

 Observe the contraindications for the medication used,

such as

- general clinical instability of the patient

- severely reduced lung function

- treatment with beta blockers

- hyperresponsiveness

- pregnancy.

 A physician or specially trained staff must be present

while bronchial provocation tests are being performed.

EasyOne Pro™ / EasyOne Pro™ LAB 11

Introduction

The patient should never be left unattended during the tests.

 The following should be available throughout provocation

tests:

- a medical specialist capable of treating acute bronchospams

- appropriate medication as well as resuscitation equipment (defibrillator, cardiac pacemaker)

 Refer to the relevant literature for creating safe protocols

for bronchial provocation tests. Examples are: Sterk PJ, Fabbri LM, Quanjer PhH, et al. Airway responsiveness. Standardized challenge testing with pharmacological, physical and sensitizing stimuli in adults. Report Working Party Standardization of Lung Function Tests. European Community for Steel and Coal. Official position of the European Respiratory Society. Eur Respir J 1993; 6: Suppl.16, 53–83).

Caution

Equipment Damage—Before connecting the device to the power line, check that the voltage and frequency ratings of your power line match the values indicated on the device nameplate.

Equipment Damage—Protect the equipment from viruses, malware, etc. Always check the USB flash drive for viruses, before connecting it to the equipment.

Equipment Damage—Do not set up EasyOne Pro™ in the direct vicinity of a window. Rain, humidity and sunlight may damage EasyOne Pro™. Do not operate EasyOne Pro™ in the vicinity of heating appliances (radiators). Do not block air vents and do not place any objects on the device.

Equipment Damage—Do not drop EasyOne Pro™.

Equipment Damage—For equipment transport, switch off EasyOne Pro™ and store it in its original packing.

Restricted Sale—U.S. Federal law restricts this device to sale by or on the order of a physician.

12 EasyOne Pro™ / EasyOne Pro™ LAB

Introduction

EasyOne Pro™ LAB only

Danger

Explosion Hazard—

 Ensure that persons working with oxygen have undergone

special training and are aware of the particular properties of oxygen to guarantee safe handling of oxygen without accidents. Furthermore, these persons must be familiar with this operator manual and must have understood its content.

 Do not use hand cream or other skin care products.

 Oxygen intensively promotes combustion; therefore,

flammable substances must be kept away from oxygen.

 Unintended release of oxygen in confined spaces

increases risk of fire; smoking and open flames are prohibited. Possible sources of ignition must be eliminated. Rooms must be well ventilated.

 The oxygen inlet must periodically be checked for leaks

(at least once a month).

 Use only fittings approved for use with oxygen; these

fittings must be properly connected. All fittings, downstream lines and devices must be free of oil and grease.

 Connect a pressure relief valve to the pressurized gas

cylinder before opening it! Before connecting the pressure relief valve, check the connection sleeve of the pressurized gas cylinder for contamination. Contaminated connections must be cleaned with a clean cloth. The valve of the pressurized gas cylinder may be opened only if the connected fittings are closed. Open the valve of the compressed gas cylinder very slowly.

EasyOne Pro™ / EasyOne Pro™ LAB 13

Equipment Symbols

0120

Introduction

Observe the information given in the operator manual.

Do not reuse (single patient use).

CE marked per the Medical Device Directive 93/42/EEC of the European Union.

Product certification for the USA and Canada.

Connection to power line ON (mains power switch).

Connection to power line OFF (mains power switch).

Temperature and humidity sensor.

Potential equalization pin.

Alternating voltage.

Gas inlet for DLCO gas.

Gas inlet for O2 (oxygen).

The number found under this symbol is the date of manufacture in the YYYY-MM format.

Manufacturer

14 EasyOne Pro™ / EasyOne Pro™ LAB

1.7 Intended Use

The ndd EasyOne Pro™ Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals.

The EasyOne Pro™ Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine.

The EasyOne Pro™ Respiratory Analysis System 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.

Introduction

Type BF applied part

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Consult Operator Manual!

Hardware revision.

1.8 Contraindications to Performing DLCO Tests

Do not perform a DLCO test

 in the presence of carbon monoxide toxicity

 in case of dangerous levels of oxyhemoglobin desaturation without

supplemental oxygen

1.9 Additional Functions of EasyOne Pro™ LAB

EasyOne Pro™ LAB includes the measurement of the FRC (Functional Resid-

ual Capacity) based on the Multiple Breath Nitrogen (N This method is based on washing out the N2 from the lungs, while the patient breathes 100% oxygen. The analysis of the expired N2 trace is used to compute the FRC and other parameters like LCI (Lung Clearance Index) that are used to quantify distribution inhomogeneities of the lung. The test is based on tidal breathing only and can easily be performed in adults and children starting at age 4.

EasyOne Pro™ / EasyOne Pro™ LAB 15

) Washout method.

Introduction

A Mains connector B Power supply unit C Hard disk D Storage disk (backup) EIndustrial standard PC F PC ports (USB, LAN, etc.) G Automatic data acquisition H Sensor for ambient temperature and

humidity IPump J Pneumatic system K Demand valve LCO sensor M Molar mass sensor N Display with touch screen

O Replaceable filter pack P Gas supply tubing QDLCO valve R Motor block SSensor T Gas cylinder for DLCO tests

U Oxygen cylinder for FRC test or wall

outlet (EasyOne Pro™ LAB only)

V Oxygen supply unit (EasyOne Pro™

LAB only)

1.10 Components and Functional Description of EasyOne Pro™

Fig. 1-1 EasyOne Pro™, block diagram

16 EasyOne Pro™ / EasyOne Pro™ LAB

Introduction

EasyOne Pro™ consists of a compact main unit and a hand-held flow sensor S with removable DLCO valve unit Q. The hand-held sensor is electrically connected to the device. For DLCO tests, a gas supply tube P delivers gas to the DLCO valve. The sensor measures flow velocity, volume and molar mass of the gases that the patient inhales and exhales.

The mains connector A connects the device to line power. The gas cylinder T supplies the medical gas mixture that is required to perform DLCO tests (normally 0.3% CO, 10% He, 21% O

A temperature and humidity sensor H measures the temperature and humidity in the examination room.

The device contains an industrial standard PC E (Windows XP embedded) that performs data acquisition, data analysis and storage of test results.

The user interface for display and control consists of a flat panel display with touch screen N. If required a keyboard and/or a mouse can be connected to the PC. A pneumatic system J delivers gas to the patient, allows flushing of the DLCO gas delivery hose and draws gas samples from the patient's inspiratory and expiratory breath. The side stream flow used for gas analysis is driven by a pump I. CO gas is analyzed by a sensor based on infrared absorption L. A molar mass sensor M based on ultrasound transit time measurement determines the helium content of the respired air.

The oxygen supply unit V required by the EasyOne Pro™ LAB version is located on the left side of the device.

Note

EasyOne Pro™ includes the Touch-It Virtual Keyboard developped by Chessware SA.

in N2).

1.11 EasyOne Pro™ Flow Sensor Design and Operation

The ultrasound flow sensor measures the transit time to determine flow velocity, volume and molar mass of the gas (molecular weight x concentration). The illustration below explains the measuring principle: two ultrasound sensors emit very short ultrasound pulses that travel along the transmission path to the opposite ultrasound transducer. Measuring the transit times allows the flow velocity to be determined very accurately and independently of temperature, humidity and molar mass of the gas. Since the measuring principle is based on a digital measurement technique, the sensor requires only one single calibration. The sensor calibration does not change during the sensor's lifetime.

EasyOne Pro™ / EasyOne Pro™ LAB 17

ultrasound sensor 1

ultrasound sensor 2

integrated mouthpiece

Fig. 1-2 Flow sensor

1.12 Test Gas Requirements

DLCO Test Gas

Caution

Patient Hazard, Incorrect Measurements—

Observe local regulations. Use only medical-grade gases, if required.

Make sure that only ndd-approved gas mixtures are used. If the gases used do not meet the ndd specifications, equipment malfunction may occur and the test results may be incorrect.

Introduction

18 EasyOne Pro™ / EasyOne Pro™ LAB

Gas mixture: 10% helium, accuracy +

10%; 0.3% carbon monoxide, accu-

racy +10%;18 to 25% oxygen, balance nitrogen

DLCO simulator test require gas mixtures with an accuracy <

Note

You can purchase all necessary gases and cylinders as well as the fittings from your local supplier of medical gases. Equipment not intended for mobile use can also be used with large gas cylinders.

Use only the supplied original tubing to connect the gas cylinder to the device.

Use only the original gas supply tube to connect the valve unit to the device.

2%.

Introduction

Warning

Improper handling of gas cylinders represents a major risk to persons and the environment. The relevant regulations must be observed without exception. Protect the gas cylinders from falling. The content and fill level must be clearly visible at all times. Valves, fittings, connections and tubing must be free of oil and grease. Have the cylinder inspected regularly by an official test authority. The user is liable for any damage. Close the main valve whenever the gas cylinder is not in use!

FRC Gas (100% O2), EasyOne Pro™ LAB only

Medical grade oxygen; 100 % O2. From compressed gas cylinders or the hospital's oxygen supply system.

Note

When using the wall outlet, please observe the hospital's inhouse instructions and requirements.

EasyOne Pro™ / EasyOne Pro™ LAB 19

Start-up and Initial Preparation

2 Start-up and Initial Preparation

2.1 Unpacking, Environmental Conditions

Transport Damage

Upon arrival, immediately check that the shipment is complete and undamaged. If you have a complaint, promptly notify the shipping agent and your local ndd dealer.

Check each of the following items:

 the housing  the sensor and its connection cable  the valve unit including the overpressure valves and the one-way

valve

 the gas supply tube  the power cord  the gas cylinder fittings.

Cleaning Before Initial Use

EasyOne Pro™ does not require cleaning before its first use.

The gas supply tube and the valve unit are cleaned before shipping, but not disinfected. These parts can be thoroughly cleaned as described in chapter

"Hygiene, Cleaning, Maintenance, Disposal" on page 100.

Ambient Conditions

Excessive amounts of dust, lint, and miscellaneous clutter around the instrument could result in malfunctions due to internal tubing blockages, overheating of components, clogged ventilation ports, etc.

EasyOne Pro™ can be operated under the following ambient conditions:

 temperature +5 to +40 °C (41 to 104 °F)

(LAB: 10 to 40 °C (50 to 104 °F))

 relative humidity 15 to 95%, no condensation

(LAB: 30 to 75%, no condensation)

 atmospheric pressure 700 to 1060 hPa.

Note

Also observe the information given in section

"Electromagnetic Compatibility (EMC)" on page 154.

20 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

abc d fe

a Sensor holder, extendible b Sensor cable connection c Connection for gas supply tube to sen-

sor

dON/OFF switch eTouch stylus f Sensor (see Fig. 2-3)

2.2 Equipment Description

Fig. 2-1 EasyOne Pro™

EasyOne Pro™ / EasyOne Pro™ LAB 21

Start-up and Initial Preparation

gqlhi mn pj k o r

g USB ports (keyboard, mouse, printer) h Memory card slot cover (Flash card,

see "Data Backup on Memory Card" on

page 102) i LAN ports (printer) j Monitor k Serial RS232 ports l Connection for temperature and

humidity sensor

m Connection for tube from DLCO gas cyl-

inder n Potential equalization pin o Screw to secure the filter pack (must be

removed before the filter can be

replaced) pNameplate q Mains connector, mains power switch

r Connection for O

gas supply system

(EasyOne Pro™ LAB only)

Fig. 2-2 EasyOne Pro™, rear panel

22 EasyOne Pro™ / EasyOne Pro™ LAB

Fig. 2-3 Sensor

st u w xv

s Coupling ring for the gas supply tube t Overpressure valves uOne-way valve

v DLCO barriette™ or for LAB FRC barri-

ette™ w Motor block, release button xspirette™

Start-up and Initial Preparation

2.3 Preparing the Device

 Connect the sensor cable to the device.

Fig. 2-4 Connecting the sensor cable

EasyOne Pro™ / EasyOne Pro™ LAB 23

Start-up and Initial Preparation



Connect the gas supply tube to the valve unit:

Note

Be sure to connect the side of the tube with the colored coupling ring to the device.

 Slip tubing connector onto connection at sensor  Screw coupling ring tight.

Fig. 2-5 Connect gas supply tube to valve unit

 Connect the other end of the gas supply tube to the device and tighten

the coupling ring.

Fig. 2-6 Connecting the gas supply tube to the device

24 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

 Attach the valve unit to the sensor (aligning the arrow) and advance the

valve unit until you hear it click into place (press button a to unlock).

Note

The valve unit must be mounted on the sensor only for DLCO and FRC tests. All other tests are performed without the valve unit.

Fig. 2-7 Attaching the valve unit to the sensor

 Pull out the sensor holder on the left side of the device (a, Fig. 2-1) and

place the sensor in the holder.

If you are working with the sensor stand (optional accessory), you can position the sensor such that the patient is not required to hold it during the tests.

 Using the clamp, screw the sensor stand to the table top.

 Open the catch and insert the sensor.

 Close the catch.

Fig. 2-8 Inserting the sensor in its stand

EasyOne Pro™ / EasyOne Pro™ LAB 25

 Connect the temperature and humidity sensor.

Fig. 2-9 Temperature and humidity sensor

2.4 Gas Supply

Start-up and Initial Preparation

Note

Ensure that the sensor is exposed to the normal room temperature and that it will not measure incorrect values because of exposure to a draft from the blower, to lamps or direct sunlight.

DLCO Gas

Note

It is very important to comply with the information given in chapter "Test Gas Requirements" on page 18.

The gas cylinder fittings (pressure relief valve) must meet the following minimum requirements:

 input pressure on primary side: 150 to 300 bar (depending on

max. cylinder pressure)

 output pressure on secondary side: 0 to 6 bar  flow rate: 6 L/s minimum

You can purchase all necessary gases and cylinders as well as the fittings from your local supplier of medical gases.

Equipment not intended for mobile use can also be used with large gas cylinders.

Use only the supplied original tubing to connect the gas cylinder to the device.

Use only the original gas supply tube to connect the valve unit to the device.

26 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

a b dc e

a Gas cylinder main valve b Manometer, primary side c Pressure relief valve, secondary side

d Manometer, secondary side e Port for EasyOne Pro™ connection tube

(DLCO gas)

Warning

 Check that the gas meets ndd specifications.

 Check that the main valve a and the pressure relief valve c are closed.

Fig. 2-10 Gas cylinder fittings

 Connect the tube to the DLCO gas port on EasyOne Pro™: push the tube

onto the stud, exerting sufficient force to overcome the initial resistance; then advance the tube as far as it will go.

Note

It is important to slide the tube at least 19 mm onto the stud.

To remove the tube, push the bushing ring back and pull the

EasyOne Pro™ / EasyOne Pro™ LAB 27

tube off the stud.

Start-up and Initial Preparation

If the tube end shows signs of mechanical damage (grooves), cut off the damaged portion.

Fig. 2-11 Connection for tube from DLCO gas cylinder

 Connect the other end of the tube to the pressure relief valve c.

 Open the main valve a of the gas cylinder completely.

 Slowly open the pressure relief valve c and set the manometer d to a

secondary pressure of 4 to 5 bar.

Note

A DLCO overpressure valve that opens at 7.5 bar is integrated in the device. If you select a higher secondary pressure, the overpressure valve will open and gas will escape.

Exchange the gas cylinder if the primary pressure drops below 10 bar!

Warning

Be sure not to confuse the DLCO gas inlet and the FRC gas inlet.

28 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

FRC Gas (100% O2), EasyOne Pro™ LAB only

Medical grade oxygen is used for FRC measurements with EasyOne Pro™ LAB.

Note

Observe the information given in the section "Test Gas

Requirements" on page 18.

Pressurised Gas Cylinder

The cylinder fitting (pressure relief valve) must meet these minimum requirements:

 input pressure on primary side: 150 to 300 bar (depending on max.

cylinder pressure)

 output pressure on secondary side: 3 to 4 bar  flow rate: 0.7 L/s at minimum (at 3 bar)

 Connect the gas supply as described on the following pages.

Warning

Central Gas Supply

The supply system must meet these minimum requirements:

 output pressure: 3 to 4 bar  flow rate: 0.7 L/s at minimum (at 3 bar)

 Obtain a suitable O

 Connect the O

 Connect the quick connect coupler to the FRC gas inlet at the EasyOne

Pro™ LAB (Fig. 2-13).

EasyOne Pro™ / EasyOne Pro™ LAB 29

adapter.

adapter to the quick connect coupler at the device.

Start-up and Initial Preparation

a b dc e

a Gas cylinder main valve b Manometer, primary side c Pressure relief valve, secondary side

d Manometer, secondary side e Port for EasyOne Pro™ LAB connection

tube (FRC gas)

 As an alternative, use a 6-mm nipple with a suitable adapter. Slip on the

gas supply tube and secure it with a tube clip.

 Check that the main valve a and the pressure relief valve c are closed.

Fig. 2-12 Gas cylinder fittings

 Connect the tube to the FRC gas inlet at the EasyOne Pro™ LAB (Fig.

2-13): push the tube onto the stud, exerting sufficient force to overcome the initial resistance; then advance the tube until the stop.

Note

It is important to slide the tube at least 19 mm onto the stud.

To remove the tube, push the bushing ring back and pull the tube off the stud. If the tube end shows signs of mechanical damage (grooves), cut off the damaged portion.

30 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

Fig. 2-13 Connection for tube from FRC gas cylinder

 Connect the other end of the tube to the pressure relief valve c.

 Open the main valve a of the gas cylinder completely.

 Slowly open the pressure relief valve c and set the manometer d to a

secondary pressure of 3 bar.

Danger

Explosion Hazard—An FRC overpressure valve that opens at 5 bar, is integrated in the device. If you select a higher secondary pressure, the overpressure valve will open and gas will escape.

Note

Exchange the gas cylinder if the primary pressure drops below 10 bar!

2.5 Connecting the Keyboard and the Mouse

EasyOne Pro™ is equipped with a touch screen display and can thus be operated without a keyboard or a mouse. However, if you prefer working with a keyboard and a mouse, connect them to a USB port (g, Fig. 2-2).

2.6 Connecting the Printer

Depending on the printer used, connect it to one of the USB ports (g, Fig. 2-2) or to one of the LAN ports i.

Note

Preinstalled and compatible printer models (please contact your ndd dealer to find out about other options):

 HP Deskjet 6988

EasyOne Pro™ / EasyOne Pro™ LAB 31

Start-up and Initial Preparation

 HP Deskjet 6940  HP Officejet H470  HP Universal Printing PCL5 (see below).

 In the main menu, select Utilities -> Configuration -> Printer.

 Open the printer list and select the printer.

Fig. 2-14 Printer tab

Printing with HP Universal Printing PCL5 (network printer)

 In the drop-down list, select "HP Universal Printing PCL" and confirm with

OK.

 Select the test to print.

Fig. 2-15 Test selection

32 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

 Press Print: the printer window will appear.

Fig. 2-16 Printer window

 Select Search for Network printers....

Fig. 2-17 Printer window

 Select the printer to use.

2.7 Power

Caution

Equipment Damage—Before connecting the device to the power line, verify that the ratings of your local power line are those indicated on the device nameplate.

Warning

Shock Hazard—Do not use this equipment unless it is properly connected to earth ground.

EasyOne Pro™ / EasyOne Pro™ LAB 33

Start-up and Initial Preparation

acb

a Potential equalization pin b Mains connector

c Mains power switch

Use only the original ndd power cord supplied with the device.

If the device is used within a medical system, it must be connected with the room's central potential equalization system (pin a, Fig. 2-18).

Using improperly grounded equipment could result in serious injury or death and severe damage to the equipment and interconnected equipment. Grounding reliability and leakage current suppression can only be assured when the power connectors are properly connected to earth-grounded receptacles.

Note

EasyOne Pro™ meets the safety requirements of UL, NFPA, LACTL, CSA, TUV, BSI, and IEC-60601 for leakage currents.

The device is checked for leakage current before shipment. The ndd service representative (or distributor representative) will assist hospital personnel in verification, if requested.

Leave the mains power switch c on all the time and use the ON/OFF switch on the front panel to switch the device on and off. Turn off power with the mains power switch only when the device will not be used for some time.

 Connect the power cord to connector b, then plug it into the wall outlet.

Fig. 2-18 Mains connection

34 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

2.8 Inserting the One-Way Valve, DLCO barriette™/FRC barriette™ and spirette™

One-Way Valve, DLCO barriette™

Note

The valve unit is only required for DLCO and FRC tests. All other tests are performed without the valve unit. The device is to be operated only with the original ndd DLCO barriette™.

Warning

Cross Contamination Between Patients—The DLCO barriette™ is intended for single patient use. Use a new one

for each patient to prevent cross contamination between patients.

 Attach the one-way valve to the valve unit (aligning the arrows) as shown

in Fig. 2-19 and turn it clockwise as far as possible.

Fig. 2-19 Attaching the one-way valve

EasyOne Pro™ / EasyOne Pro™ LAB 35

Start-up and Initial Preparation

 Insert the DLCO barriette™ in the one-way valve (aligning the arrows) as

shown in Fig. 2-20 and check that it sits tight.

Fig. 2-20 Inserting the DLCO barriette™

FRC barriette™ (EasyOne Pro™ LAB only)

Note

The FRC barriette™ is required only when also FRC tests will be performed with the EasyOne Pro™ LAB. If the EasyOne Pro™ LAB is used for DLCO testing, the DLCO barriette™ will also have to be attached here. The device is to be operated only with the original ndd FRC

barriette™.

Warning

Cross Contamination Between Patients—The FRC barriette™ is intended for single patient use. Use a new one for each patient to prevent cross contamination between patients.

36 EasyOne Pro™ / EasyOne Pro™ LAB

Start-up and Initial Preparation

Fig. 2-21 Inserting the FRC barriette™

spirette™

Note

The device is to be operated only with the original ndd spirette™.

Warning

Cross Contamination Between Patients—The spirette™ is intended for single patient use. Use a new one for each patient to prevent cross contamination between patients.

 Tear open the plastic bag containing the spirette™ and fold the bag back

so that you can insert the spirette™ in the flow sensor. Ensure that the plastic bag protects the mouthpiece of the spirette™ until you hand the flow sensor over to the patient.

This approach not only ensures perfectly hygienic conditions, it also keeps the spirette™ closed for subsequent setting of the baseline.

 Insert the spirette™ - as shown in the illustration - into the flow sensor

as far as possible. When doing this, please ensure that the arrow on the spirette™ is lined up with the arrow on the flow sensor.

 You remove the spirette™ by pushing it out of the sensor from below.

EasyOne Pro™ / EasyOne Pro™ LAB 37

Start-up and Initial Preparation

Fig. 2-22 Inserting the spirette™

2.9 Switching the Device On, Functional Test

 Open the main valve of the gas cylinder(s) completely.

 Check the secondary pressure: for DLCO gas , it must be 4 to 5 bar, and

for FRC gas, it must be 3 bar (EasyOne Pro™ LAB only).

 Turn on the mains power switch on the rear panel of the device.

 Turn on the device with the power button: the green indicator is

illuminated.

Fig. 2-23 Power button

After a short start-up phase, the initial screen will be displayed.

Note

If the initial screen appears and no error messages display, the device is in perfect operating condition.

38 EasyOne Pro™ / EasyOne Pro™ LAB

cfgia hbde j

a Selected patient b Practice, office, hospital (see "General

Tab " on page 111 for details about

entering the data)

c Click to select a patient or add a new

patient dClick to perform a test e Click to review the results from previ-

ous tests f Click to view the setup screen g Sensor status (sensor icon, if sensor is

connected) h Click to display the keypad i Help button j Click to quit the program

Fig. 2-24 Initial Screen

Start-up and Initial Preparation

Note

EasyOne Pro™

activate a button by touching it on the display.

(h, Fig. 2-24) is used to display and remove the touch

keypad that allows you to make all entries.

Before the first test, you should follow the instructions given in "System Settings" on page 110 and

 enter the practice/office or hospital name  select the language  select the test types and parameters

Note

After each exchange of the gas cylinder, check whether the gas concentration in the program corresponds to the specifications on the cylinder

EasyOne Pro™ / EasyOne Pro™ LAB 39

is equipped with a touch screen display. You

. Follow these steps:

Start-up and Initial Preparation

 Select Utilities -> Configuration -> Test -> DLCO.

 Compare the displayed values with the data on the gas cylinder.

 Close the tab with OK.

Fig. 2-25 DLCO tab

40 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

a cde ibfhg j

a Selected patient b Bar cursor for patient selection c Click to add a new patient d Click to perform a test with the selected

patient

e Click to view the selected patient's test

results f Click to edit the selected patient's data g Click to delete the data of the selected

patient (password-protected, EOPTM

or 8005) h Help button i Filter Last Name; by entering one or

more letters, you limit the number of

patients to those meeting the filter cri-

teria j Additional parameters k Back to main menu

3 Performing a Test

Note

Before performing a test, you should do the following:

 select the test details

(e.g. only expiratory or inspiratory and expiratory FVC measurement, predicted value calculation, etc., see "Test Tab" on page 116)

 select a patient from the database as described below, or enter a

new patient in the database. As an alternative you can perform a Quick Test which will be saved to the database with an automatically assigned ID (e.g. Q_0033) (see "Quick Test" on page 66).

3.1 Selecting/Adding a Patient

 Click Select Patient.

The patient list will be displayed.

Fig. 3-1 Patient list

EasyOne Pro™ / EasyOne Pro™ LAB 41

Selecting the Patient

The displayed patients can be sorted by

 Patient ID  Last Name  First Name  Date of Last Test.

 To do so, click on the appropriate title in the column headers.

 To search for a specific patient, you enter the first letter(s) of the

patient's last name at h.

 You select a patient by clicking in the corresponding line of the list: the

bar cursor highlights the selected patient. At the same time, the patient's name appears at a.

Note

Click to view the patient data. Click again to close the window.

Performing a Test

Fig. 3-2 Window showing patient data

42 EasyOne Pro™ / EasyOne Pro™ LAB

Adding a New Patient

a b c

 Click New Patient.

 Enter a patient ID and press the TAB key or the Enter key (click to

enter an automatically generated ID).

 Enter the last and first names in the same way.

 Click a (Fig. 3-3) to select the gender and press the TAB key.

 Also, select the ethnic origin b.

 Enter the date of birth, height and weight.

Note

The information regarding gender, age, height, weight and ethnic origin must be correct, because it is used to calculate the predicted values and to interpret the acquired data.

Additional information can be entered on the Smoking History (see Fig. 3-4), History and Comment tabs c.

 Close the window with OK.

The patient list will be displayed and the new patient is selected.

Performing a Test

Fig. 3-3 Patient data window

EasyOne Pro™ / EasyOne Pro™ LAB 43

Fig. 3-4 Smoking History tab

Merging a Patient’s Data Records

You can merge data records for one and the same patient, for example, if they were acquired with different tests or if different spellings of the patient's name exist. Use Drag & Drop (right mouse button) to merge data records.

Performing a Test

Fig. 3-5 Merging a patient’s data records

44 EasyOne Pro™ / EasyOne Pro™ LAB

3.2 Selecting a Test

The test selection screen will appear either directly after entry of the patient data or it can be accessed from the initial screen with Perform Test.

Fig. 3-6 Test selection screen

Note

If the unit selected is EasyOne (see "Device Tab" on page 124), you will see Fig. 3-7.

Observe the instructions shown on the monitor screen and on the display of the EasyOne when performing tests and the subsequent synchronization.

Refer to the EasyOne tab (see "EasyOne Tab" on page 125) for configuration options.

Performing a Test

Fig. 3-7 Selection screen when the selected device is EasyOne

EasyOne Pro™ / EasyOne Pro™ LAB 45

Performing a Test

bc e i jaf kdh

a Selected test parameters b Predicted values, past test results of

the patient c Flow-volume loop area d Start button eScaling f Displayed curve selection: best trial,

best trial and pre trial, all trials g Show/hide the animation program for

children (incentive) h Show/hide expanded parameter list i Volume-time curve area j Test information and system interpre-

tation area k Click to perform a new test, to view the

patient's test list, to select a new

patient and to print a test

3.3 Forced Vital Capacity (FVC/FVL)

 Click FVL (ex/in).

The acquisition screen will be displayed.

Note

The scale for the flow-volume loop depends on the selected test (only expiratory or inspiratory and expiratory, tidal breathing yes/no).

Expiratory FVC Measurement

Fig. 3-8 Expiratory FVC acquisition screen

46 EasyOne Pro™ / EasyOne Pro™ LAB

Preparations

The patient should be relaxed and should not wear tight clothing. The patient may stand or sit during the test. In exceptional cases, the patient may feel dizzy when performing the test. Therefore, watch your patients closely, if they are standing for the test.

Performing a Test

Explain that the purpose of the test is to determine how much air a person’s lungs can hold and how quickly that air can be expelled. Since the spirometry test requires active participation by the patient, it is very important to explain the test maneuver:

 take the spirette™ into the mouth with the lips sealing around the

spirette™, taking care not to block its opening with the tongue or bite down excessively on the spirette™

 breathe calmly  fill lungs completely  exhale as hard and fast as possible  continue blowing out until the lungs are completely empty  breathe in again.

If you perform spirometry tests with EasyOne Pro™ on patients for the first time, you should practice testing yourself and others prior to testing patients. You will learn to recognize the cause of problems by interpreting the Quality Messages displayed by the program after each effort and how to avoid these problems. After a poor effort explain to your patient how to improve the maneuver.

Fig. 3-9 Patient using the sensor

Caution

Risk of Injury—Pulmonary function tests require maximum effort on the part of the patient and may lead to dizziness.

Risk of Infection—The spirette™ is designed for single use. Use a fresh spirette™ for each new patient.

Risk of Infection—In settings where tuberculosis or other diseases that are spread by droplet nuclei are likely to be encountered, proper attention to environmental engineering

EasyOne Pro™ / EasyOne Pro™ LAB 47

Performing a Test

controls, such as ventilation, air filtration or ultraviolet decontamination of air, should be used to prevent disease transmission.

Risk of Infection—Clean the nose clip after each patient.

Measurement

 Insert the new spirette™ in the sensor.

 Attach the nose clip to the patient.

 Press Start.

The device advises you to keep the spirette™ closed until the test start prompt is displayed. This is necessary to set the baseline correctly.

Note

ndd recommends leaving the spirette™ packaging in place until after the baseline has been set.

 Block off the spirette™ on one end and confirm the message with OK.

 When the start test prompt is displayed, hand the sensor over to your

patient and instruct him or her to perform the maneuver as explained earlier.

Note

If the "Manual Test Stop" option was selected in the configuration (see "Test Tab" on page 116), the operator must terminate the measurement by clicking the Test End button or by pressing the space bar or the Enter key.

During the test, you will see the flow-volume loop and the volume-time curve on the display. All curves and measured values will be displayed after the test.

48 EasyOne Pro™ / EasyOne Pro™ LAB

Fig. 3-10 Acceptable FVC test

aabef gc d

aPredicted values bTest results c Area for review comments d Click to perform a post-test (see "Bron-

chodilation (Post-Tests)" on page 53)

e Test information, system interpretation

f Click for a retrospective test evaluation

or to expand the parameter list (see

"Retrospective Test Assessment, Enter-

ing Comments" on page 97)

g Click to view more test information and

system interpretation statements

Performing a Test

In order to assess the patient's pulmonary function, it is necessary to achieve acceptable test quality. The test quality depends on the co-operation of the patient which, in turn, depends on the quality of the physician's instructions. EasyOne Pro™ incorporates an automatic quality control function. This function analyzes the test quality and displays a message to inform you as to whether the maneuver was acceptable or not (see "System

Interpretation" on page 96). This function also allows the physician to

improve patient instructions.

When three acceptable maneuvers have been performed, the message

sion complete!

appears. If, even after repeated attempts, it is not possible to obtain an adequate number of good maneuvers, you should take a break, depending on how the patient feels, or stop the measurement. Even after a break, the measurement results remain stored.

 Click Add Trial for each subsequent spirometry maneuver.

A review comment can be entered in area c or the results can be edited (do not forget to give the reviewer's name).

EasyOne Pro™ / EasyOne Pro™ LAB 49

Ses-

Performing a Test

a cb

a Quality grade b Click to perform a post-trial (see "Bron-

chodilation (Post-Tests)" on page 53)

c Area for review comments

a b c

When three acceptable tests have been performed, the message Session complete! appears and a quality grade from A (optimal) to F a is displayed.

Fig. 3-11 Acquisition screen after three acceptable, expiratory FVC tests

Note

If FEV6 is selected (instead of FVC), the measurement will stop automatically after 6 seconds.

%Pred Graph

The %Pred graph is a three-segment bar. The left segment a indicates a value below the lower limit of normal, the middle segment b represents a value between the lower limit and the predicted value and the right segment c indicates a value above the predicted value. FVC, FEV1 and FEV1/ FVC are displayed in color, all other parameters are grey.

Fig. 3-12 %Pred graph

50 EasyOne Pro™ / EasyOne Pro™ LAB

Adding a Spirometry Trial

If you would like to add trials to a previous test, e.g. if the patient needed a break or if other patients were tested in between, please proceed as follows. Remember, however, that it is only possible to add a trial to a previous test that was performed on the same day.

 Select the patient.

 Click Perform Test.

 Select the test, e.g. FVC.

A menu will appear.

Fig. 3-13 Menu

 Click Add Trial or Add Post.

The acquisition screen will be displayed.

 Perform the new spirometry maneuvers.

Performing a Test

FVL Test (inspiratory and expiratory measurement)

Ambient Conditions

The ATPS values (Ambient Temperature Pressure Saturated = spirometer conditions) of inspiratory measurements must be converted to BTPS values (Body Temperature Pressure Saturated = body conditions). For this conversion, the system needs the following data:

 relative humidity  room temperature  atmospheric pressure or altitude.

Before the inspiratory test can be started, a window pops up with these data. Check the data. For the pending test you can now edit the data, if necessary, or confirm them, if they are correct.

EasyOne Pro™ / EasyOne Pro™ LAB 51

Performing a Test

a bc d e

a Conversion factors b Box for entry of the humidity c Box for entry of the ambient temperature d Box for entry of the altitude (atmospheric

pressure)

e Click to recalculate the BTPS factor (if the

ambient conditions were modified)

f Click to confirm and accept the values

Fig. 3-14 Window showing the ambient conditions

 Edit the values, if necessary, and click Confirm >> to close the window.

Warning

Erroneous Measurement Results—Incorrect entries may lead to erroneous test readings and incorrect system interpretations. The specified measuring accuracy is ensured only when all entries are correct.

The inspiratory and expiratory FVL test acquisition screen appears.

Measurement

 Prepare the patient (see "Preparations" on page 46) and explain the test

maneuvers to him or her:

 take the spirette™ into the mouth with the lips sealing around the

spirette™, taking care not to block its opening with the tongue or bite down excessively on the spirette™

 breathe calmly  fill lungs completely

52 EasyOne Pro™ / EasyOne Pro™ LAB

 exhale as hard and fast as possible  continue blowing out until the lungs are completely empty  inhale as hard and fast as possible.

 Conduct the tests as described in section "Measurement" on page 48.

Note

The volume-time curve (Fig. 3-16) does not display the forced inspiration at the end of the maneuver.

Bronchodilation (Post-Tests)

The Post test is usually performed to determine the patient's response to bronchodilating asthma medication. This is done by administering a bronchodilator to the patient after he or she has performed a spirometry test (Pre-Test). Approximately 10 to 20 minutes after the medication (when bronchodilator shows effect, refer to medication labelling) a second spirometry test is performed. After the test the Pre and Post results are compared. Post tests can only be added to previous tests performed on the same day.

 Select the patient.

 Select the test, then click Add Post to close the window.

The window with the patient's existing tests appears. With left) you display the detailed results of the Pre tests (Fig. 3-15 right).

Performing a Test

(Fig. 3-15

Fig. 3-15 Detailed test results

 Conduct the tests as described in section "Measurement" on page 48.

As soon as three acceptable trials have been performed, the message Session complete! appears and a quality grade from A (optimal) to F is dis-

played (see "Quality Messages and Quality Grades" on page 84).

EasyOne Pro™ / EasyOne Pro™ LAB 53

Performing a Test

Fig. 3-16 Acquisition screen after three acceptable post-trials

54 EasyOne Pro™ / EasyOne Pro™ LAB

Animation Program for Children

An animation program for children is available for FVC, FVL and SVC tests. You can choose between two animations: Balloon and Monkey. When the animation program is activated, we recommend disabling the manual test stop and working with the automatic test stop (see "General Tab" on page 111).

Performing a Test

Fig. 3-17 Balloon animation program for children, test start, successful test

Fig. 3-18 Monkey animation program for children, test start

The Monkey animation can be viewed in full-screen mode .

EasyOne Pro™ / EasyOne Pro™ LAB 55

3.4 Vital Capacity (SVC)

Slow vital capacity measurements determine the vital capacity, starting from tidal breathing. (You can configure the device for direct measurement of the vital capacity, i.e., without initial tidal breathing (see "SVC Tab" on page 120). For this test type, too, the ATPS values (Ambient Temperature Pressure Saturated = spirometer conditions) must be converted to BTPS values ( Body Temperature Pressure Saturated = body conditions) (see "Ambi-

ent Conditions" on page 51).

After three acceptable trials, the message Session complete! appears.

 Select the patient (see "Selecting/Adding a Patient" on page 41).

 Prepare the patient (see "Preparations" on page 46) and explain the test

maneuvers to him or her:

 take the spirette™ into the mouth with the lips sealing around the

spirette™, taking care not to block its opening with the tongue or bite down excessively on the spirette™

 breathe calmly in and out  when the start test prompt appears, take a maximum inspiration

followed by an immediate, but unhurried, exhalation.

 Select SVC.

The slow vital capacity acquisition screen appears.

Performing a Test

56 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

a b c e hd f

a Selected test parameters bPredicted values c Volume-time curve area d Start button e Test information and system interpre-

tation area

f Click for a retrospective test evaluation

or to expand the parameter list (see

"Retrospective Test Assessment, Enter-

ing Comments" on page 97)

g Click to view additional information h Click to perform a new test, to view the

patient's test list, to select a new

patient and to print a test

Fig. 3-19 Slow vital capacity acquisition screen

 Conduct the tests as described in section "Measurement" on page 48.

EasyOne Pro™ / EasyOne Pro™ LAB 57

Performing a Test

When three acceptable trials have been performed, the message Session complete! appears and a quality grade from A (optimal) to F is displayed (see "Quality Messages and Quality Grades" on page 84).

Fig. 3-20 Acquisition screen after three acceptable SVC trials

3.5 Maximum Voluntary Ventilation (MVV)

In these tests, the maximum ventilation volume over an uninterrupted period of 12 seconds is measured. For this test type, too, the ATPS values (Ambient Temperature Pressure Saturated = spirometer conditions) must be converted to BTPS values ( Body Temperature Pressure Saturated = body conditions) (see "Ambient Conditions" on page 51).

 Select the patient (see "Selecting/Adding a Patient" on page 41).

 Prepare the patient (see "Preparations" on page 46) and explain the test

maneuvers to him or her:

 take the spirette™ into the mouth with the lips sealing around the

spirette™, taking care not to block its opening with the tongue or bite down excessively on the spirette™

 when the test start prompt is displayed, breathe in and out as deeply

and as fast as possible over a period of 12 seconds.

 Select MVV.

The MVV acquisition screen appears.

58 EasyOne Pro™ / EasyOne Pro™ LAB

Fig. 3-21 MVV acquisition screen

a b c e hd f

a Selected test parameters bPredicted values c Volume-time curve area d Start button e Test information and system interpre-

tation area

f Click for a retrospective test evaluation

or to expand the parameter list (see

"Retrospective Test Assessment, Enter-

ing Comments" on page 97)

g Click to view additional information h Click to perform a new test, to view the

patient's test list, to select a new

patient and to print a test

Performing a Test

 Conduct the tests as described in section "Measurement" on page 48.

Fig. 3-22 Acquisition screen after two acceptable MVV tests

EasyOne Pro™ / EasyOne Pro™ LAB 59

Performing a Test

3.6 Bronchial Provocation

Introduction and Safety Information

Bronchial provocation tests are performed by administering increasing doses of an airway irritant. The reaction of the respiratory system to these substances is measured. A number of standardized substances are available as provocative agents.

Danger

Patient Hazard —

 Bronchial provocation tests can be dangerous for

patients! A primary condition for safe provocation test procedures is a trained and experienced physician.

 Physicians must be familiar with appropriate precautions

and guidelines, warnings, procedures, contraindications, when to stop further testing, etc. as defined in the medication documentation and in the standards.

 Observe the contraindications for the medication used,

such as

- general clinical instability of the patient

- severely reduced lung function

- treatment with beta blockers

- hyperresponsiveness

- pregnancy.

 A physician or specially trained staff must be present

while bronchial provocation tests are being performed. The patient should never be left unattended during the tests.

 The following should be available throughout provocation

tests:

- a medical specialist capable of treating acute bronchospams

- appropriate medication as well as resuscitation equipment (defibrillator, cardiac pacemaker)

 Refer to the relevant literature for creating safe protocols

60 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

acefb g h id

a Selected protocol bProtocol steps c Current test step d Start button eNext action

fBaseline g Threshold line h Measured values in tabular form i Zoom icon to change the scale

European Respiratory Society. Eur Respir J 1993; 6: Suppl.16, 53–83).

Performing a Test

 Select a medication (Challenge Test Protocol, see "Provocation Tab" on

page 123). The following is a brief description of how to perform a measurement with the Methacholine ATS short protocol (5 breaths).

 Select the patient (see "Selecting/Adding a Patient" on page 41).

 Explain the test maneuver to your patient and attach the nose clip.

 Select Provocation.

The initial screen is displayed.

Fig. 3-23 Initial screen for bronchial provocation tests

EasyOne Pro™ / EasyOne Pro™ LAB 61

The baseline is determined either at the pre-test stage or at the 0 mg/ml level, depending on the test protocol. Three acceptable FEV1 measurements should be available for the baseline determination (see "Forced Vital Capac-

ity (FVC/FVL)" on page 46).

 Click Start to initiate the measurement.

Performing a Test

b c d

a Toggles between volume-time and test

diagramm

b Current test step

c Click to add an FEV1 measurement d Click to display the protocol screen

a b

a Current test step bPre-test value

c Next action dMenu button

When three acceptable maneuvers have been performed, the message Session complete! Great Job! appears.

Fig. 3-24 Screen after three acceptable expiratory FVC measurements

 Click Protocol (d, Fig. 3-24) to display the protocol screen.

Fig. 3-25 Protocol screen

Note

If a reduced lung function is determined, the physician needs to decide if and how to continue the test.

With Menu d, you can display a number of keys and then return to the FVC acquisition screen with Spirometry, for

62 EasyOne Pro™ / EasyOne Pro™ LAB

example.

 Now proceed to the next test step (c, Fig. 3-25) and confirm with Done.

The next step will be displayed and the next action indicated at c is Wait 30 seconds.

 When the waiting time is over, click Done (you can abort the waiting time

at any time with Done).

The next step will be displayed and the next action is Perform repeatable

FEV1 measurements.

Fig. 3-26 Protocol screen

Performing a Test

 Click Start to initiate the FEV1 measurement.

Note

After the FEV1 measurement, you need to check whether the measurement quality is sufficient or whether additional trials are required.

With key a (Fig. 3-24) you can display the test diagram (response curve) at any time during the test.

 Click Protocol to display the protocol screen: the measurement and the

next step will be displayed and the next action shown in this example is Administer 0.0625 mg/mL concentration.

EasyOne Pro™ / EasyOne Pro™ LAB 63

Fig. 3-27 Protocol screen

 Continue executing the remaining levels. As soon as you reach the 20%

limit, the message POSITIVE TEST RESULT... will appear, the next level (Post) and the next action Administer a bronchodilator will be displayed.

Note

Some protocols require the administration of a bronchodilator even for tests with a negative result.

Performing a Test

Fig. 3-28 Protocol screen with a positive test result

64 EasyOne Pro™ / EasyOne Pro™ LAB

 Perform the post test according to the instructions. Then the final proto-

col screen with the post-rest results will be displayed.

Fig. 3-29 Protocol screen

Note

After the test, the patient should leave the laboratory only after the obstruction is reversed either spontaneously or upon administration of a bronchodilator substance. The reversal should be documented with a lung function test.

Performing a Test

EasyOne Pro™ / EasyOne Pro™ LAB 65

3.7 Quick Test

You have the option to perform a quick test without entering patient data. When Quick Test is selected, no predicted values are available, because they are calculated on the basis of the patient data.

 In the main menu, select Perform Test.

A menu will appear.

Fig. 3-30 Menu

 Click Quick Test and perform the test as usual.

Performing a Test

Note

It is not possible to edit the predicted values retrospectively once measurements have been taken.

The Quick Test feature is not available for DLCO tests.

66 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

3.8 CO Diffusing Capacity (DLCO)

Note

Before conducting the DLCO test, the valve unit must be attached to the sensor (see Fig. 2-7). Furthermore, a new barriette™ and, in case of a new patient, a new spirette™ must be inserted (see "Inserting the One-Way Valve, DLCO

barriette™/FRC barriette™ and spirette™" on page 35).

Before performing the first DLCO test, check that the valve unit is properly attached and that the metal coupling ring of the motor is tight.

Before performing a DLCO test, you should measure the vital capacity.

It is recommended to perform two DLCO tests. The pause between the two tests must be at least 4 minutes. However, do not perform more than five consecutive DLCO tests on one patient (ATS/ERS Taskforce recommendations, literature [11] ("Literature" on page 182).

 Select the patient (see "Selecting/Adding a Patient" on page 41).

 Attach the nose clip to the patient and explain the test maneuvers to him

or her:

 Select DLCO.

 In the BTPS window, confirm the values for relative humidity,

temperature and atmospheric pressure with Conf irm.

 Check that the patient sits fully upright and wears the nose clip.

 Instruct the patient to hold the sensor straight (not at an angle) in front of

his or her mouth without taking the spirette™ into the mouth yet.

Fig. 3-31 shows the patient during a test, using the sensor stand (optional accessory).

EasyOne Pro™ / EasyOne Pro™ LAB 67

Performing a Test

Fig. 3-31 Patient using the sensor (with optional stand)

 Press Start on the acquisition screen. EasyOne Pro™ will automatically

complete a start-up routine in about 15 seconds.

 Initialization  Test preparation  Tidal breathing

 When you see the message Start tidal breathing, instruct the patient to

take the sensor into the mouth with the lips sealing around the spirette™ and to start the tidal breathing maneuver.

 After 3 or 4 breaths, the Activate button appears. Now instruct the

patient to fully exhale.

 During exhalation, press the Activate button: the valve will automatically

close at the end of exhalation. it is also possible to manually close the valve by pressing the Manual Close button.

 Now instruct the patient to fully inhale (the patient is expected to inhale

85% of their vital capacity within 2 to 4 seconds) and then hold their breath for 10 seconds (wait for the valve to close before breathing in).

 After the 10 seconds, the valve opens and the patient is required to

exhale normally (avoiding forced or slow exhalation) and continue tidal breathing until the test stops.

After a successful test, the message Good effort will be displayed.

68 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

a bc de jk l mf

h i

a Tidal breathing b Complete exhalation c Holding breath for 10 seconds d Collection bar (its width depends on

the selected sampling volume m) e Complete exhalation f Keys to expand the curve (to check the

collection bar for artifacts) g Click to show/hide more curves (mouth

pressure, flow)

h Box for comments (touch to display the

keypad)

i Click to show and hide control buttons

for the collection bar j Click to reset the collection bar k Click to move the collection bar to the

right l Click to adjust the DLCO measurement

(see "Introduction to Adjustment of

DLCO Measurements" on page 146)

m Click to select the sampling volume

Fig. 3-32 DLCO test

EasyOne Pro™ / EasyOne Pro™ LAB 69

The collection bar identifies the range that was analyzed.

With the + button f, you can expand the curve to check the collection bar range for artifacts (click - to reset the bar to its original width).

With Collection Bar i you can show and hide control buttons for the collection bar (j, k, m).

Performing a Test

With > k you can move the collection bar to the right. The resulting, new values will immediately be calculated and displayed.

With I<< j you return the collection bar to its original position.

The text box h provides space for comments. A keypad will be displayed as soon as you touch the area.

You can double-click on a point in the curve windows to hide a curve. The curve reappears when you double-click once more.

70 EasyOne Pro™ / EasyOne Pro™ LAB

Introduction

Performing a Test

3.9 FRC Test (EasyOne Pro™ LAB only)

FRC measurement is based on the nitrogen (N2) washout method where N2 is washed out from the lungs while the patient breathes 100% oxygen. The test is performed during tidal breathing within the range indicated at a (Fig. 3-26). After a (configurable) number of breaths, the measurement starts automatically or it can be started manually with the Activate button.

Note

Before conducting the FRC test, the valve unit must be attached to the flow sensor (see Fig. 2-7). Furthermore, a new

FRC barriette™ spirette™

Valve, DLCO barriette™/FRC barriette™ and spirette™" on

page 35).

Before performing the first FRC test, check that the valve unit is properly attached and that the metal coupling ring of the motor is tight.

Inform patients that they may experience a feeling of dryness during inhalation. Also, they will hear oxygen escape during the washout phase.

You can choose between the following tests:

 manual mode  automatic mode.

Additionally, the FRC test linked with SVC is available (Linked FRC Test with SVC (online)), see "FRC (mbw) Tab" on page 122):

 No linked SVC  SVC before washout  SVC after washout.

and, if a new patient is tested, a new

must be inserted (see "Inserting the One-Way

Note

The method recommended by ATS/ERS is the linked SVC test.

No linked SVC

Only a plain FRC washout is performed. If an SVC test has been performed before, the lung volume parameters, such as TLC, ERV and RV, will be calculated based on this external SVC test.

EasyOne Pro™ / EasyOne Pro™ LAB 71

Performing a Test

Note

Interpret these results with caution because different breathing baselines are possible.

SVC before washout

Relaxed tidal breathing until a stable breathing baseline is detected (indicated with a line in the VT-diagram representing the breathing baseline line). Then perform a full SVC maneuver; after that continue with the FRC washout maneuver. Lung volume parameters will be calculated based on this linked SVC maneuver (data from an "external" SVC test will not be used).

Note

Perform the SVC maneuver according to ATS/ERS guidelines to ensure accurate results.

SVC after washout

First perform an FRC washout maneuver. After the washout continue with relaxed tidal breathing until a stable breathing baseline is detected (indicated with a line in the VT-diagram representing the breathing baseline line). Then perform a full SVC maneuver. Lung volume parameters will be calculated based on this linked SVC maneuver (data from an "external" SVC test will not be used).

Note

Perform the SVC maneuver according to ATS/ERS guidelines to ensure accurate results.

Performing a Test

Note

The patient wears a nose clip during the measurement and the lips must seal around the mouthpiece to prevent ambient air from being inhaled.

 Instruct the patient according to the displayed on-line messages. The

messages depend on the mode settings "Automatic" or "Manual" and on the selected option "Linked SVC".

 Attach the FRC barriette™ (see "FRC Test (EasyOne Pro™ LAB only)" on

page 71).

 Select the patient (see "Selecting/Adding a Patient" on page 41).

 Select the test with FRC.

 The FRC test acquisition screen appears.

72 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

 Explain the test maneuver to the patient and prepare him or her for the

test:

 attach the nose clip  take the spirette™ into the mouth with the lips sealing around the

spirette™ , taking care not to bite down excessively on the spirette™

 sit upright  during the test, the patient should breathe quietly and steadily. The

respiratory flow should not exceed the displayed range (a , Fig. 3-26).

In automatic mode, the test starts automatically after the "Number of breaths before test start" and ends automatically when the measured concentration drops repeatedly below the limit of 2 % (as configured under

"FRC (mbw) Tab" on page 122).

In manual mode, beginning and end of the Washout phase must be manually determined.

After a successful test, the message Good effort will be displayed.

EasyOne Pro™ / EasyOne Pro™ LAB 73

Fig. 3-33 FRC test (offline linked)

a b ecd

aTest result b Measuring curve c Volume-time curve (only shown for

"linked" measurements)

d Click to enter a comment

e Tracer curve (logarithmic representa-

tion, see "FRC (mbw) Tab" on

page 122) f Flow indicator (during the washout

phase, the flow should remain in the

green range)

Performing a Test

Fig. 3-34 FRC test (online linked)

74 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

3.10 Ending the Test

At the end of the test, push the spirette™ out of the sensor from below. Dispose of it and do not reuse. Also, replace the barriette™ after each patient. Refer to section "Hygiene, Cleaning, Maintenance, Disposal" on page 100 for sensor cleaning instructions.

Warning

Risk of Infection—

 spirette™ and DLCO barriette™/FRC barriette™ are

intended for single patient use. Use new ones for each new patient.

 After tests on patients with an infection of the respiratory

tract or patients with a suspected infection of the respiratory tract, it is recommended to clean all parts (outside of the sensor) that were touched during the test, before testing a new patient (see "Hygiene, Cleaning,

Maintenance, Disposal" on page 100).

3.11 Retrieving/Printing Stored Tests

EasyOne Pro™ saves all tests. Old measurements can be called up at any time to

 perform a new test with the same patient  add a spirometry trial  add a post-medication test  review or print the results.

Note

It is only possible to add a trial to a previous test that was performed on the same day (see "Adding a Spirometry Trial" on page 51).

 Select the patient (see "Selecting/Adding a Patient" on page 41).

EasyOne Pro™ / EasyOne Pro™ LAB 75

Performing a Test

 Click the History button (Fig. 3-35).

Fig. 3-35 Retrieving/printing stored tests

A window listing all tests stored for this patient will appear.

Fig. 3-36 Test list

The displayed tests can be sorted by

 test protocol (Base, Pre, Post)  test type (FVC, SVC, MVV)  test date  comment.

 To do so, click on the appropriate title in the column headers.

 Highlight the test to view.

 Click View Test to view the test, Print Preview to view the test before

printing it, Print to print the test, or Trend to view the trend display (see

"Trend View" on page 78). Click Patients to display the patient list and

click New Test to display the test selection menu.

Note

Alternative: Double-click on a test to display it.

76 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

c d

a Window showing the currently selected

test report

b Click to open the layout selection menu

c Click to print the displayed report d Click to access a submenu with options

for zooming, exporting, viewing,

printer selection and additional print

functions

Examinations for which a Post-test exist, are identified by a

small arrow symbol

When you select Print Preview, you will see the print preview of the test:

 select b to display the test report menu (report layout)  select c to print the test (select the printer)  select d to change the display scale.

Fig. 3-37 Print preview of the test

Fig. 3-38 Menu bar when the Print Menu button is pressed

EasyOne Pro™ / EasyOne Pro™ LAB 77

3.12 Trend View

a bc d

a Option buttons for selection of the view b Displayed parameter labels

c Click to select a parameter d Icon to initiate the trend printout

The trend views allow you to observe the measured parameter values over a period of time. You can choose between two different views:

 One of the views simultaneously presents up to four parameters,

allowing them to be compared. Each parameter has its own vertical axis and scale.

 In the second view, a single parameter can be compared with the

predicted normals.

Performing a Test

Fig. 3-39 Trend view of multiple parameters

78 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

Fig. 3-40 Trend view of a single parameter and its predicted normals

EasyOne Pro™ / EasyOne Pro™ LAB 79

Performing a Test

3.13 Definition of Important Parameters

FVC Forced Vital Capacity

(expiratory)

FIVC Forced Vital Capacity

(inspiratory)

FEV1 Forced Expiratory Volume

(1 s)

FEV6 Forced Expiratory Volume

(6 s)

forced expiratory vital capacity

forced inspiratory vital capacity

forced expiratory volume after 1 second

forced expiratory volume after 6 seconds

FEV1/FVC ratio of FEV1 to FVC

FEV1/VC

max

ratio of FEV1 to VC

max

FEV1/FEV6 ratio of FEV1 to FEV6

FEF 50 (MEF 50)

FEF 25-75 Mid-Expiratory Flow (25%-

Mid-Expiratory Flow (50%) flow at 50% of expiratory

vital capacity

flow at 25% to 75% of

75%)

expiratory vital capacity

PEF Peak Expiratory Flow peak expiratory flow

PIF Peak Inspiratory Flow peak inspiratory flow

VT Tidal Volume Tidal volume at rest

ERV Expiratory Reserve Volume expiratory reserve volume

IRV Inspiratory Reserve Vol-

inspiratory reserve volume

ume

VCmax Maximum Vital Capacity maximum vital capacity of

an SVC, FVC, FVL or DLCO test

VCex Expiratory Vital Capacity expiratory vital capacity of

a slow spirometric test

VCin Inspiratory Vital Capacity inspiratory vital capacity of

a slow spirometric test

VC Vital Capacity vital capacity of a slow spi-

rometric test

80 EasyOne Pro™ / EasyOne Pro™ LAB

Performing a Test

IC Inspiratory Capacity inspiratory capacity

(VT + IRV)

MVV Maximum Voluntary Venti-

lation

maximum ventilation volume per minute

LLN Lower Limit of Normal lower limit of normal

Lung Age lung age, see section "Pre-

dicted Values" on

page 139 [8]

DLCO CO diffusing capacity

(ml/min/mmHg)

TLCO CO diffusing capacity

(mmol/min/kPa)

DLadj Diffusing capacity

adjusted (Hb, PaO

, COhb,

CO diffusing capacity (ml/min/mmHg)

CO diffusing capacity (mmol/min/kPa)

adjusted diffusing capacity

altitude)

VA Alveolar volume (BTPS) alveolar volume (BTPS)

VI Inspiratory Capacity from

DLCO maneuver

inspiratory capacity from a DLCO test

DLCO/VA Krogh Factor Krogh factor

TLC Total Lung Capacity total lung capacity

Note

The parameter names used by ndd Medizintechnik AG are those standardized by ATS and ERS. (See literature references [14] and[11] ("Literature" on page 182).

For forced spirometric tests and depending on your configuration, the "Best" column in the result table shows the "Best Value" of all accepted trials or the "Best Trial", i.e., the value of the best trial ("Test Tab" on page 116).

The most important parameters will be explained below:

For slow spirometry (SVC), the mean value of the accepted trials will be shown with the following exceptions: VT, ERV, IRV, IC.

For DLCO, the mean values will be displayed in the "Result" column for the following parameters: DLCO, VA, TLCO, DLAdj and TLC.

EasyOne Pro™ / EasyOne Pro™ LAB 81

FRC

Performing a Test

FRC

Functional Residual Capacity

LCI Lung Clearance Index (equals CEV

divided by FRC at 1/40th of initial tracer concentration (2% N2), see

"Literature" on page 182 [16])

CEV Cumulative Expired Volume

VT Tidal Volume

VT/kg Tidal Volume/kg

f Breathing Frequency

M0, MR1, MR2

Moment Value and Moment Ratios 1 and 2 from nitrogen washout moment analysis. Clinical use of these parameters is limited since the available reference data is based on a small number of patients (see "Literature" on page 182 [17] to [21]); for a detailed description, please refer to chapter "Easy-

One Pro LAB Washout Moment Analysis" on page 180 in the

Appendix of this manual.

These definitions apply to FRC:

mean value: FRC, IC, ERV, VT, IRV , LCI, CEV, VT, M0, MR1, MR2

Get largest VC from FRC maneuver

RV[reported] = FRC[average] - ERV[average]

TLC[reported] = RV[reported] + VC[largest] = FRC[average] - ERV[average] + VC[largest]

82 EasyOne Pro™ / EasyOne Pro™ LAB

Editing Patient Data

4 Editing Patient Data

 On the initial screen, click Select Patient.

 Select the patient.

 Click Edit Patient.

The patient data window will appear.

Fig. 4-1 Patient data window

 Change or add data.

 Click Update existing tests to close the window (for example, if the

entered patient data were incorrect and the tests need to be recalculated) or close the window with OK if you want to apply the edited data to future tests only.

EasyOne Pro™ / EasyOne Pro™ LAB 83

Quality Messages and Quality Grades

5 Quality Messages and Quality Grades

5.1 FVC/FVL Quality Messages and Quality Grades

Some Basic Facts

End-of-Test criteria, quality criteria and quality grading are based upon the published standards [1], [4], [11], [15] ("Literature" on page 182).

Quality grading is based on [4], [11], [15] ("Literature" on page 182).

Additional remarks



The main articles [2] and [3] do not numerically define the minimum expiratory peak flow time (PEFT) that is required for an acceptable test. In this case, 160 ms is used.

 The end-of-test criteria for FVC tests are as follows: A test ends when the

volume change during the last 2 seconds is <45 ml, or an inspiratory volume >150 ml is detected. This end-of-test criterion slightly differs from the published criterion in [3] which is 25 ml in the last second. Reason: When the 25 ml in 1 second criterion is applied to the 24 waveforms also defined in [1] and [2], several curves will end too early, and these tests might fail. We therefore decided to slightly change the criterion to 45 ml in 2 seconds.

 In the following tables the quality messages and the quality criteria are

detailed.

The end-of-test criterion for an FVC test is as follows: A test ends when the volume change during the last 2 seconds is <45 ml, or an inspiratory volume >150 ml is detected. When this end-of-test criterion is met, the following quality messages are checked:

84 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

FVC/FVL Quality Messages

Message Criterion

Don’t hesitate … Back-extrapolated volume greater

than 150 ml or 5% of FVC whichever is greater (for age or 12.5% of FVC whichever is greater)

Blast out faster … Time until peak flow greater than

Blow out longer … Expiration time less than 2 sec-

Test Abr upt En d! FVC Test onl y: Expira ti on ti me less

Good effort, do next …Test meets above criteria. Good trial. Only one to two more

Do not start too early!

160 ms

onds OR volume in the last 0.5 seconds of the expiration larger than 100 ml

than 2 seconds OR volume during last 0.5 seconds >40 ml when expiration time is <6 seconds OR volume during last second >25 ml when end-of-test was initiated by an inspiration.

The time to peak flow (PEFT) is less than 30 ms or flow detected before sensor was initialized (Wait until 'Start Maneuver …' is displayed)

6: 80 ml

Recommended action

The patient must exhale all air at once and not exhale in short bursts.

The patient must exhale more explosively and as firmly and quickly as possible.

The patient stopped exhaling too early. The patient must exhale still further and force as much air as possible out of his or her lungs.

good trials and the test is complete.

Instruct the patient to wait until the baseline setting is finished and the device signals that the trial can start ('Start maneuver …')

Cough detected. Try again…

A cough has been detected (PEF or PIF >19 l/s)

Instruct the patient to avoid coughing during the measurement. Repeat the test.

EasyOne Pro™ / EasyOne Pro™ LAB 85

Quality Messages and Quality Grades

Message Criterion

Deeper breath … FEV1 or FVC* not reproducible.

Difference with respect to best test greater than 150 ml or 100 ml

No maneuver detected!

Session Complete! Great Job!

if FVC is < 1.0L (for age or 10% of FEV1 or FVC* whichever is greater)

No parameter calculation possible Instruct the patient to perform the

QC grade A or B reached. The test is complete. An adequate

6: 100 ml

* When using FEV6 instead of FVC, FEV6 is also used for the determination of the quality message.

FVC/FVL Quality Grades

Rating Criteria

A At least 3 acceptable tests (for age

best two FEV1 and FVC values is equal to or less than 100 ml (80 ml if FVC < 1.0 l) (for age

6: 80 ml or 8% of FVC whichever is greater)

6: 2 acceptable) AND the difference between the

Recommended action

The test differs greatly from previous tests. The patient can inhale even more deeply and exhale even more air.

maneuver according to its definition.

number of good tests is available.

B At least 3 acceptable tests (for age

best two FEV1 and FVC values is equal to or less than 150 ml (100 ml if FVC < 1.0 l) (for age

6: 100 ml or 10% of FVC whichever is greater)

C At least 2 acceptable tests AND the difference between the best two FEV1 and FVC

D (1) At least 2 acceptable trials but the results are not reproducible according to 'C'.

D (2) Only one acceptable trial

F No acceptable trial available

values is equal to or less than 200 ml (150 ml if FVC < 1.0 l) (for age 15% of FVC whichever is greater)

Quality message: "Result not reproducible" OR only one acceptable trial. Quality message: "Only one acceptable trial".

6: 2 acceptable) AND the difference between the

6: 150 ml or

86 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

5.2 SVC Quality Messages and Quality Grades

The quality grading is based on [3].

SVC Quality Messages

The end-of-test criterion for an SVC test is the same as for an FVC test: A test ends when the volume change during the last 2 seconds is 30 ml (test time 6 s) 45 ml (test time > 6 s) or if an inspiratory volume > detected.

When this end-of-test criterion is met, the following quality messages are checked:

Message Criterion Recommended action

120 ml is

Deeper breath VC of the two largest, accepted tri-

als are not reproducible. Difference with respect to best test greater than 150 ml.

No Steady-Tidal breathing detected

Maneuver incomplete

Do not start too early!

Good effort, do next Test meets above criteria. Good trial. Only one to two more

Session Complete! Great Job!

All end-inspiratory volumes of the last 3 breaths within 200 ml.

No ERV and/or no IRV could be calculated due an incomplete maneuver session.

Too early, flow detected. Instruct the patient to wait until

QC grade A, VC variability and at least 3 acceptable trials available.

150 ml

The test differs greatly from previous tests. The patient can inhale even more deeply and exhale even more air.

Instruct patient to breathe quietly and steadily.

Perform SVC test according to ERS/ATS recommendation.

the baseline setting is finished and the device signals that the trial can start ('Start maneuver …')

good trials and the test is complete.

The test is complete. An adequate number of good tests is available.

EasyOne Pro™ / EasyOne Pro™ LAB 87

SVC Quality Grades

Rating Criteria

Quality Messages and Quality Grades

A At least 3 acceptable tests AND the difference between the best VC values is equal to

B At least 2 acceptable tests AND the difference between the best VC values is equal to

D (1) At least 2 acceptable trials but the results are not reproducible according to 'B'.

D (2) Only one acceptable trial

F No acceptable trial available

or less than 150 ml.

5.3 DLCO Quality Messages and Quality Grades

The quality grading is based on ATS/ERS Guidelines [3].

DLCO Quality Messages

Message

Breath Hold Time out of Range

Maneuver not acceptable. Breath Hold Time is outside the 8-12 seconds range

Criterion

Breath-hold time outside 8 to 12 seconds

Recommended action

Exhale immediately when the valve opens

Parameter out of Range

Test cannot be evaluated; sensor signals do not pass QC check

A parameter is out of range, e.g. a gas concentration is higher or lower than permitted

0) Helium concentration out of range

1) CO at zero not within 80 ppm

2) CO at DLCO test gas not within 500 ppm

3) Alveolar CO out of range

4) Expiratory CO out of range

5) VA out of range

6) DLCO out of range

Check for leaks; make sure concentrations of gas cylinder are entered correctly

88 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

Message

Low Inspiratory Volume

Maneuver not acceptable. Inspiratory volume too low

Inspiratory Time Too Long

Maneuver not acceptable. Inspiration time exceeds the maximum of 4 seconds

Sampling volume at this position too large

Difference Preparation and Maneuver

Test cannot be evaluated; gas sensor signals do not pass QC check, possibly due to leaks

Sampling volume at maximum position

Test cannot be evaluated; exhaled volume too small

Criterion

The inspiratory volume is smaller than 85% FVC/VC/Predicted

Inspiratory time > 4 seconds Inhale test gas faster

Sample volume not correctly determined

Reference gas measurement and inspiratory gas measurements do not match within 80 ppm. This means that most probably there is a leak in the DLCO hose

Can happen when very small volumes are exhaled

Collection bar is beyond rightmost position

Recommended action

Make sure to perform a full expiration before the valve closes, and then a full inhalation of test gas

Reduce sample volume

Check for leaks; check gas supply

Activate „Automatically rejected volume“

After the breath hold, do not exhale too fast.

DLCO-Warning: High inspiratory CO during tidal breathing!

Test error: # of breaths

Test cannot be evaluated; DLCO maneuver cannot be detected

An increased CO level was detected during the tidal breathing phase.

Number of breaths during DLCO expiration could not be detected

Check the DLCO valve unit.

If the error occurs repeatedly then please contact service.

Perform the DLCO maneuver with full effort

EasyOne Pro™ / EasyOne Pro™ LAB 89

Quality Messages and Quality Grades

Message

Test error: CO-Calib

CO calibration could not be performed: no gas connected to the system or Instrument failure

Test error: Time delay

Test cannot be evaluated; gas signals do not pass QC check, automatic delay correction failed

Test error: T idal breathing

Test cannot be evaluated; no tidal breathing detected prior to DLCO maneuver

Test error: CO-Insp Drift

Maneuver not acceptable; no stable CO signal during breath-hold

Criterion

CO calibration could not be performed: Instrument failure and/or no gas connected to the system

Automatic time delay correction failed

No tidal breathing has been detected before the test

During breath-hold, CO signal drifts up or down

Recommended action

Make sure the gas supply is connected and open

Repeat test correctly

Check spirette position, check connections, check DLCO valve unit

™ und barriette™

3-point calibration failed (1)

3-point calibration failed (2)

3-point calibration failed (3)

CO concentration too high (clip)

CO sensor drift too high

S-factor of the CO sensor outside

0.16 to 0.375

3-point calibration mixture outside 750 to 1600 ppm CO

Standard deviation of CO during 3-point calibration greater than 25 ppm

CO sensor out of range If the error occurs repeatedly, then

CO drift during measurement > 150 ppm

If the error occurs repeatedly, then please contact service.

please contact service.

Repeat the test. If the error occurs again after the device has warmed-up, then please contact service.

90 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

Message

Test error: data error General error in DLCO calculation If the error occurs repeatedly, then

DLCO warning: High CO sensor drift!

CO drift during measurement >60ppm

Criterion

Recommended action

please contact service.

The test result must be interpreted with caution

EasyOne Pro™ / EasyOne Pro™ LAB 91

Quality Messages and Quality Grades

DLCO Acceptability and Quality Grades

Currently, there are not standardized quality grades for DLCO tests. These are the quality grades implemented in EasyOne Pro™ LAB:

Quality Grade Accept. Trials DLCO Variability

A>=2<1 ml/min/mmHg

B>=2<

C>=2<

D1 or

F- -

referring to the two nearest values

>=2 >3 ml/min/mmHg

2 ml/min/mmHg

3 ml/min/mmHg

The following parameters determine the score and quality grades:

 DLCO variability as a percentage and as an absolute value  number of accepted trials.

Trials that fulfill the following criteria are accepted:

 VCin >80 % VCtarget  breath hold time (BHT) 8.0 to 12.0 s  inspiratory time <4 s  sample volume >0.1 L.

Legend

VCin as a percentage of VCtarget: Inspired volume as a percentage of FVC, VC from a previous test. If none of these is available, the target value is taken from the test itself.

BHT: Breath-hold time in seconds.

Sample Volume: Sampling volume for CO and helium measurement (also called collection window). The sampling volume will be outside this window only under special circumstances (e.g. for very small VCs).

Inspiratory time in seconds.

The quality grades are recomputed if the user manually changes the sampling window position (repositioning of the collection bar).

92 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

5.4 FRC Quality Messages

Message Criterion Recommended action

FRC(MBW) Warning: Extrapolated volume computation failed (set to zero)!

FRC(MBW) Warning: Extrapolated volume computation too high (set to zero)!

FRC(MBW) Warning: Inspiratory leak!

FRC(MBW) Warning: In- or expiratory pressure too high!

The extrapolated volume could not be calculated.

The extrapolated volume (i.e., the volume that would be washed out after cancellation of the test) is greater than 1 liter.

Air entered from outside during inspiration.

The end-inspiratory molar mass deviates from the tracer gas molar mass by more than 0.2 g/mol. This is indicative of air drawn in from outside during inspiration.

Pressure in sensor tube is too high.

The pressure in the sensor tube exceeds ±5 mbar; possible reasons are:

1) Insufficient pressure at the O2

gas port.

2) Patient's breaths are too deep;

the respiratory resistance and thus the pressure drop increase from about 2 l/s.

Contact service.

Do not stop too soon.

Check FRC barriette™: are valves jammed or was the FRC barri- ette™ not been properly inserted?

Check position of spirette™ and of nose clip.

Ask patient to breathe calmly.

Check O2 gas supply: Is the inlet pressure 3 bar? Only minimal pressure variations are allowed during the test.

Is the patient's breathing too deep/too fast? Ask the patient to breathe within the limits of ±1.5 l/s.

EasyOne Pro™ / EasyOne Pro™ LAB 93

Quality Messages and Quality Grades

Message Criterion Recommended action

FRC(MBW) Warning: Side-Stream Flow out of range!

FRC(MBW) Warning: CO2 sensor scaling warning!

FRC(MBW) Warning: Tracer concentration at test end too high!

FRC(MBW) Warning: Perform deeper breaths (too small tidal volume)!

FRC(MBW) Error: No start of washout detected!

FRC(MBW) Error: Error in Gas Signal Delay Correction!

FRC(MBW) Error: Not enough breaths for washout computation!

During the test, the gas extraction

Contact service. was not within the limits of 7.5 and 13 ml/s.

Automatic scaling of the CO nal failed.

No breath with an N tion below 2% was measured.

Tidal volume outside 4 to 30 mL/ kg body weight or outside 0.25 to

concentra-

sig-

Contact service.

Repeat test.

Ask patient to breathe regularly

and calmly

0.3 L if the body weight is not stated

Multi Breath Washout not found. Perform washout procedure cor-

rectly.

An error occurred during the automatic determination of the delay between gas signals and flow (i.e.,

Check FRC barriette™ position.

Contact service.

the delay is not within the desired range).

The number of breaths required

FRC test was stopped prematurely. for calculation of FRC was not reached.

94 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

Message Criterion Recommended action

FRC(MBW) Error: Error in Tracer Gas Concentration!

FRC(MBW) Error: Error in Alveolar Curve Computation!

FRC(MBW) Error: DLCO Valve Unit NOT mounted on handle sensor!

The molar mass change caused by the tracer gas does not correspond to the theoretical values.

An error occurred during calculation of the alveolar gas curve (from the first breaths of the washout).

Check whether O2 is used.

Check gas connections for leaks.

Check FRC barriette™ position.

Check that the test is correctly

performed.

Check position of spirette™ and

of nose clip.

Contact service.

Mount valve unit and repeat pro-

cedure.

EasyOne Pro™ / EasyOne Pro™ LAB 95

Quality Messages and Quality Grades

a bcd

a Pre-medication test results b Quality grade

c System interpretation d Post-medication test results and devia-

tion from Pre-test results

5.5 System Interpretation

In assessing the system interpretation, it is important to consider the quality grade b of the test. Quality grades A to C indicate a reliable result. A quality grade of D or F indicates inadequate test quality. The result must then be interpreted with caution (see section "Interpretation" on page 135 for details).

You can view the test result on the monitor as soon as you see message

Session Complete! after performing a test.

Fig. 5-1 Test results, system interpretation

96 EasyOne Pro™ / EasyOne Pro™ LAB

Quality Messages and Quality Grades

5.6 Retrospective Test

Note

You must be logged in as a user to be able to enter a test assessment and comments.

Assessment, Entering Comments

Changing the Trial Acceptability

The trial acceptability and ranking of tests can be changed retrospectively. This means that you can make tests unacceptable that the system judged acceptable and vice versa. You can also change the trial ranking (rank 1, 2 or

3).

 Click a (Fig. 5-2).

The test assessment icons b appear on the test results screen.

Fig. 5-2 Changing the trial acceptability

Follow these steps to make a test acceptable that the system judged unacceptable:

 Click the icon.

 In the ensuing window, select the Acceptable check box.

Fig. 5-3 Changing the trial ranking

EasyOne Pro™ / EasyOne Pro™ LAB 97

Quality Messages and Quality Grades

To assign the highest rank to a test

 click the icon and

 in the ensuing window, click Set Highest Ranked (Fig. 5-4).

Note

To assign ranks 1, 2 and 3, please start with rank 3, etc.

Fig. 5-4 Changing the trial ranking

Entering comments

 Click in the comment area or click .

 Enter a user ID, followed by the comment.

 Close the window with Save.

The text will be shown in the comment window, including the user ID and the date.

Fig. 5-5 Entering comments

98 EasyOne Pro™ / EasyOne Pro™ LAB

Switching the Device Off

6Switching the Device Off

Caution

Loss of Data—Be sure to correctly terminate the program before switching EasyOne Pro™ off with the mains power switch on the back.

 Close the main valve of the gas cylinder.

 Close the main valve of the O2 gas cylinder or disconnect the wall outlet.

Note

When using the wall outlet, please observe the hospital's inhouse instructions and requirements.

 Quit the program with .

Fig. 6-1

 Switch off EasyOne Pro™ with OK, or release gas pressure with Release

pressure, if you need to replace a gas cylinder. Then click OK to confirm the message. EasyOne Pro™ will automatically switch off.

Caution

The device will switch off, but it remains connected to line power. Only with the mains power switch at the back will EasyOne Pro™ be disconnected from line power.

EasyOne Pro™ / EasyOne Pro™ LAB 99

Hygiene, Cleaning, Maintenance, Disposal

7 Hygiene, Cleaning, Maintenance, Disposal

Hygiene

Caution

Risk of Infection—

 Users with open wounds or contagious diseases on their

hands must wear gloves.

 Wash your hands after each patient to protect yourself

and to prevent cross contamination.

 The spirette™ and the barriette™ must be properly

disposed of immediately after use.

Cleaning

Warning

Shock Hazard—Disconnect the device from the power line before cleaning.



Wipe the device surface down with a cloth moistened with alcohol (70% max.), avoiding the display, the rear panel and the temperature and humidity sensor. Do not let liquid enter the device.



To clean the rear panel and the temperature and humidity sensor, simply wipe them off with a dry cloth.



The display is also cleaned with a soft, dry cloth. In case of major contamination, you can use a cloth moistened with alcohol (50% max.).



Wipe the sensor, the valve unit, the gas supply tube and the power cord down with a cloth moistened with alcohol (70% max.). Do not let liquid enter the parts. Replace the gas supply tube each year.



The connecting tube to the gas cylinder and the touch stylus can be cleaned with a cloth moistened with alcohol (70% max.).



The one-way valve can be rubbed down with a cloth moistened with alcohol (50% max.). Clean only the side facing the

barriette™

and the

housing. The one-way valve must be replaced each year.

100 EasyOne Pro™ / EasyOne Pro™ LAB

NDD easyone pro, easyone pro lab Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction

1.1 CE Marking Information

1.2 Revision History

1.3 Manual Purpose

1.4 Intended Audience

1.5 Styles

1.6 Safety Information

1.7 Intended Use

1.8 Contraindications to Performing DLCO Tests

1.9 Additional Functions of EasyOne Pro™ LAB

1.10 Components and Functional Description of EasyOne Pro™

1.11 EasyOne Pro™ Flow Sensor Design and Operation

1.12 Test Gas Requirements

2 Start-up and Initial Preparation

2.1 Unpacking, Environmental Conditions

2.2 Equipment Description

2.3 Preparing the Device

2.4 Gas Supply

2.5 Connecting the Keyboard and the Mouse

2.6 Connecting the Printer

2.7 Power

2.8 Inserting the One-Way Valve, DLCO barriette™/FRC barriette™ and spirette™

2.9 Switching the Device On, Functional Test

3 Performing a Test

3.1 Selecting/Adding a Patient

3.2 Selecting a Test

3.3 Forced Vital Capacity (FVC/FVL)

3.4 Vital Capacity (SVC)

3.5 Maximum Voluntary Ventilation (MVV)

3.6 Bronchial Provocation

3.7 Quick Test

3.8 CO Diffusing Capacity (DLCO)

3.9 FRC Test (EasyOne Pro™ LAB only)

3.10 Ending the Test

3.11 Retrieving/Printing Stored Tests

3.12 Trend View

3.13 Definition of Important Parameters

4 Editing Patient Data

5 Quality Messages and Quality Grades

5.1 FVC/FVL Quality Messages and Quality Grades

5.2 SVC Quality Messages and Quality Grades

5.3 DLCO Quality Messages and Quality Grades

5.4 FRC Quality Messages

5.5 System Interpretation

6Switching the Device Off

7 Hygiene, Cleaning, Maintenance, Disposal