Easy on-PC Operators Manual Rev V03B

Note The information in this manual applies to software version V1.5.x.x only. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. © ndd Medizintechnik AG, Zurich, Switzerland. All rights reserved. No part of this manual may be reproduced without written permission from ndd. ndd™, the ndd logo™ and spirette™ are trademarks owned by ndd Medizintechnik AG.

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

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

www.ndd.ch

www.nddmed.com

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Easy on-PC

Contents

1

Introduction

5

1.1 CE Marking Information 1.2 Licence Terms 1.3 Revision History 1.4 Manual Purpose 1.5 Intended Audience 1.6 Styles 1.7 Safety Information 1.8 Intended Use 1.9 Description of the Medical Electrical Device 1.10 Easy on-PC Sensor Design and Operation 1.11 System Requirements

5 5 6 6 6 6 7 12 13 13 14

Start-up and Preparation

15

2.1 Software Installation 2.2 Connecting the Flow Sensor 2.3 Preparing the Flow Sensor 2.4 Starting the Software Program

15 21 24 25

Performing a Test

26

3.1 Selecting/Admitting 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 Ending the Test 3.9 Retrieving/Printing Stored Tests 3.10 Trend View 3.11 Definition of Important Parameters 3.12 Editing Patient Daa 3.13 Quality Messages / Grades (Details) 3.14 System Interpretation 3.15 Retrospective Test Assessment, Entering Comments

26 31 32 42 45 47 53 53 54 57 59 61 62 67 67

4

Hygiene, Cleaning, Maintenance, Disposal

70

5

System Settings

76

6

Troubleshooting Tips

92

2

3

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Contents

4

7

Specifications

93

8

Technical Description

95

9

Order Information

97

10

Appendix

98

10.1 Interpretation 10.2 Predicted Values 10.3 GDT Interface 10.4 Report Designer 10.5 Electromagnetic Compatibility (EMC) 10.6 Quick Reference Guide to the Screen Displays 10.7 Literature

98 102 103 109 113 118 132

Easy on-PC

Introduction

1

Introduction

1.1 CE Marking Information 

The product Easy on-PC 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 Safety" as well as the electromagnetic immunity requirements of standard EN 60601-1-2 "Electromagnetic Compatibility – Medical Electrical Equipment".



The radio-interference emitted by the flow sensor 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 country of manufacture appears on the device label.

1.2 Licence Terms By installing the software, you accept the following terms. If you do not accept these terms, please return the product, including all documentation and hardware supplied with the product, to your supplier in return for the reimbursement of the purchase price. The subject of the contract is the grant of a licence to use the software and the product documentation. ndd grants you a personal, non-exclusive and non-transferable right of use. The software and the accompanying documentation are protected by copyright. The licensee shall comply with the provisions of copyright law. Ownership and all other rights to the software are retained by ndd. You may not transfer the software by network or data channel to another computer.

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5

Introduction

The software and the accompanying product documentation may not be altered or copied or, in an altered version, combined with other software and made accessible to third parties. The licensee shall be liable for all damage incurred by the licensor as the result of a violation of copyright in breach of these terms of contract.

1.3 Revision History Edition

Date

Comment

Version V01

2008-07-22

Initial Release

Version V01 Rev. A

2008-09-18

Revised Version

Version V01 Rev. B

2010-03-04

Revised Version

Version V02

2010-04-06

Revised Version

Version V03

2012-11-26

Revised Version

Version V03b

2012-12-06

Revised Version

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

1.5 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.

1.6 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, Easy on-PC.

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Easy on-PC

Introduction

1.7 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 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 electromedical equipment standard IEC 60601-1-1.



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.

© 2012 ndd Medizintechnik AG, Technoparkstr. 1, CH-8005 Zurich, Switzerland

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Introduction

Definitions In this manual the safety information is classified as follows: 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.

Safety Information Danger Explosion Hazard-The flow sensor is not designed for use in areas of medical locations where an explosion hazard may occur. 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.

Warning Shock Hazard-

8



If the flow sensor is connected to a PC, this PC must meet the requirements outlined in the Technical Description chapter.



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 Easy on-PC

Introduction

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. 

Before using the device, the operator must ascertain that it is in correct working order and operating condition. The cables, in particular, must be checked for signs of damage. Damaged cables and connectors must be replaced immediately, before use.



Liquids must not be allowed to enter the flow sensor or the PC. Devices into which liquids have entered must immediately be cleaned and checked by a service technician, before they can be reused.

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 132). Patient Hazard-User-configured printouts bear the label "Custom Report". The user is entirely responsible for the design, content and use of the printouts. 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.

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Introduction

Risk of Infection-Proper use of the spirette™ provides a reliable infection barrier. The use of other accessories is not permitted. 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. 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 point when performing bronchial provocation tests:

10



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. 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, Easy on-PC

Introduction

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

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Introduction

Equipment Symbols Observe to the information given in the Operator Manual.

Single-patient use CE marked per the Medical Device Directive 93/42/EEC of 0120 the European Union. The number found under this symbol is the date of manufacture in the YYYY-MM format.

Manufacturer

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!

1.8 Intended Use The software program Easy on-PC in conjunction with the flow sensor is designed for spirometric measurements in adults and children over the age of 4. The Easy on-PC system is used by general practitioners, specialists, in occupational medicine and in hospitals; it may also be used in frontline applications (pharmacies, screening places, first aid centers). Easy on-PC is used in combination with the spirette™ respiratory tube to conduct slow and forced spirometric maneuvers and MVV tests. The Easy on-PC software contains data management functions such as displaying, reporting and exporting of test data.

12

Easy on-PC

Introduction

1.9 Description of the Medical Electrical Device The Easy on-PC software is installed on a PC or laptop computer to which the flow sensor is connected by means of a USB cable. The PC or laptop computer which is not part of the equipment supplied by ndd Medizintechnik AG is thus considered a requisite accessory necessary for the intended use of the device. The requirements for the PC and laptop computer as well as for other peripheral devices such as the monitor and the printer are specified in chapter "Technical Description" on page 95. The applied part comprises the handle and the spiretteTM. The connection cable is not included.

Fig. 1-1

Medical electrical device

1.10 Easy on-PC 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.

Easy on-PC

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Introduction

integrated mouthpiece

Fig. 1-2

ultrasound sensor 2

ultrasound sensor 1

Flow sensor

1.11 System Requirements minimum requirements operating system

Windows 7®, Windows 8®, 1), Windows XP® SP3, Windows Vista® (32 bit and 64 bit) 1)Windows 8®: EasyOne-line (Screen-

Connector) and units with serial numbers <80000 are not currently supported. Web browser

Internet Explorer 6 or later

processor

Intel® -/Pentium® processor or compatible, 1 GHz

monitor resolution

1024 x 600

hard drive memory

installation/system: 1 GB data memory 4 GB

RAM

512 MB

Beyond the minimum requirements, a larger RAM of >1 GB and a larger monitor with a resolution of 1280 x 960, for example, would be recommended.

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Easy on-PC

Start-up and Preparation

Note The software supports only 100% DPI (if a value different than 100% is selected, information may not be displayed completely. Use ClearType to enhance screen fonts (for Windows XP, refer to http://support.microsoft.com/kb/306527/en-us; for Windows Vista or newer operating systems, ClearType is the default setting).

2

Start-up and Preparation

2.1 Software Installation Note Install the software on the PC before connecting the flow sensor. You will require Administrator privileges to install the software on the PC. The installation dialogs are available in English only. 

Exit all programs and insert the Easy on-PC CD in the CD ROM drive. As a rule, the installation routine starts automatically within 30 seconds of inserting the CD. If the installation routine does not start automatically, go to the CD-ROM directory and start the EasyWareProStarter.exe program.

Fig. 2-1

Easy on-PC

15

Start-up and Preparation

Installation with Windows 7® (For installation in a Windows XP® environment, please refer to "Installation with Windows XP®"

on page 20 )

Fig. 2-2 

Click Next.

Fig. 2-3

16

Easy on-PC

Start-up and Preparation 

Confirm with I Agree.

Fig. 2-4 

Click Next >.

Fig. 2-5

Easy on-PC

17

Start-up and Preparation

Option: Installing .NET Framework 4 (if not already installed)

Fig. 2-6 

Click Install.

Fig. 2-7

18

Easy on-PC

Start-up and Preparation 

Confirm with Finish.

Fig. 2-8 

When this dialog is displayed, select Restart Now.

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19

Start-up and Preparation

Installation with Windows XP® 

System requirements: Windows XP® SP3.



Before the installation, confirm the Run As... dialog to obtain Admin privileges (Admin privileges must be confirmed before the installation of each sub-module, i.e., the user is repeatedly asked to confirm).



Users with Admin privileges should clear the Protect my computer .. check box.

Fig. 2-9 

20

Install .NET Framework 4 and restart the computer if prompted to do so.

Easy on-PC