ndd Medical Technologies
Easy on-PC Operators Manual V02
Operators Manual
120 Pages
Preview
Page 1
Easy on-PC Operator's Manual
Version V02
Note The information in this manual applies to software version V01.02 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. Easy on-PC and spirette are trademarks owned by ndd.
ndd Medizintechnik AG Technoparkstrasse 1 CH-8005 Zürich, Switzerland Tel: +41(44) 445 2530 Fax: +41(44) 445 2531
USA Office ndd Medical Technologies 2 Dundee Park Andover, MA 01810 Tel: (1) 1 978 470 0923 Fax: (2) 1 978 470 0924
www.ndd.ch
www.nddmed.com
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Easy on-PC
Contents
1
2
3
4 5 6 7 8 9 10
Introduction
4
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
4 4 5 5 5 5 6 9 9 10 11
Start-up and Preparation
12
2.1 Software Installation 2.2 Connecting the Easy on-PC Sensor 2.3 Preparing the Easy on-PC Sensor 2.4 Starting the Software Program
12 17 20 21
Performing a Test
22
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 Quick Test 3.7 Ending the Test 3.8 Retrieving/Printing Stored Tests 3.9 Trend View 3.10 Editing Patient Data 3.11 Quality Messages / Grades (Details) 3.12 System Interpretation 3.13 Retrospective Test Assessment, Entering Comments 3.14 Parameter Definitions
22 25 25 36 38 40 40 40 43 45 46 51 51 54
Hygiene, Cleaning, Maintenance, Disposal System Settings Troubleshooting Tips Specifications Technical Description Order Information Appendix
56 58 74 75 77 79 80
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
80 84 88 94 98 103 116
Easy on-PC
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Introduction
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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 product Easy on-PC 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 Easy on-PC 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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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
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.
Easy on-PC
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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.
No part of this manual may be reproduced without written permission from ndd.
© 2008 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 Easy on-PC 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-
If the Easy on-PC 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
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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 Easy on-PC 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-User-configured printouts bear the label "Custom Report". The user is entirely responsible for the design, content and use of the printouts. 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.
Caution U.S. Federal law restricts this device to sale by or on the order of a physician.
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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 Easy on-PC 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.
1.9 Description of the Medical Electrical Device The Easy on-PC software is installed on a PC or laptop computer to which the Easy on-PC sensor is connected by means of a USB cable.
Easy on-PC
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Introduction
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 77. 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.
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Introduction
integrated mouthpiece
Fig. 1-2:
ultrasound sensor 2
ultrasound sensor 1
Easy on-PC Sensor
1.11 System Requirements minimum requirements operating system
Windows 2000® SP4, Windows Server® 2003, Windows XP® SP2, Windows Vista®
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.
Easy on-PC
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Start-up and Preparation
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Start-up and Preparation
2.1 Software Installation Note Install the software on the PC before connecting the Easy onPC 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:
The following window will be displayed:
Fig. 2-2:
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Start-up and Preparation
Note To view the Operator Manual, select the language and click View Manual. If no PDF viewing program is installed, the Adobe Reader will be installed first.
Click Install Software to initiate the installation routine.
Fig. 2-3:
Click Accept.
Fig. 2-4:
Click Next>.
Easy on-PC
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Start-up and Preparation
Fig. 2-5:
Click Next> to confirm the proposed installation path. Click Browse..., if you wish to select another installation path. In the lower area of the window you determine the program users: Everyone means the program will be accessible to all users, Just me means that only you will have access to the program.
Fig. 2-6:
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Read the licence terms. You accept these terms with I Agree.
Click Next>.
Easy on-PC
Start-up and Preparation
Fig. 2-7:
Click Next > to start the actual software installation routine.
Fig. 2-8:
Easy on-PC
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Start-up and Preparation
Fig. 2-9:
Click Continue Anyway.
Fig. 2-10:
Click Close to finish the installation routine. Remove the CD from the drive.
After a successful installation you will find the Easy on-PC icon your desktop.
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Easy on-PC
on
Start-up and Preparation
2.2 Connecting the Easy on-PC Sensor For operation of the Easy on-PC Sensor, the corresponding driver must be installed. Note In most situations the CD-ROM will not be required for installation of the driver, because the driver already exists on the PC.
After installation of the Easy on-PC software program, connect the USB connector of the Easy on-PC Sensor to a free USB port on your PC.
The message New hardware found will appear. You will also see the Found New Hardware Wizard.
Fig. 2-11:
Answer the prompt Can Windows connect to Windows Update to search for software with No, not this time and click Next >.
.
Fig. 2-12: Easy on-PC
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Start-up and Preparation
At the prompt What do you want the wizard to do? select Install the software automatically (Recommended) and click Next >.
Fig. 2-13:
After the driver has been found on the system, the following message displays:
Fig. 2-14:
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Start-up and Preparation
Accept the proposed driver and click Finish.
Fig. 2-15:
Click OK to save the new COM port. Note Please note that you will have to install the driver again, if the Easy on-PC Sensor is connected to a USB port on which it was not used before.
Easy on-PC
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Start-up and Preparation
2.3 Preparing the Easy on-PC Sensor Warning Shock Hazard-If the Easy on-PC Sensor is connected to a PC, this PC must meet the requirements of IEC standard 60950-1.
Tear open the plastic bag containing the spirette™ and fold the bag back, allowing you to insert the spirette™ into the Easy on-PC Sensor. Ensure that the plastic bag protects the mouthpiece of the spirette™ until you hand over the Easy on-PC Sensor to the patient.
This approach not only ensures perfectly hygienic conditions, it also keeps the spiretteTM closed for the subsequent determination of the baseline.
Introduce the spirette™ - as shown in the illustration - into the Easy onPC Sensor as far as possible. When doing this, please ensure that the arrow on the spirette™ is lined up with the arrow on the Easy on-PC Sensor .
You remove the spirette™ by pushing it out of the sensor from below. 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.
Fig. 2-16:
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Inserting the spirette™
Easy on-PC