NDD EasyOne Pro Operator's Manual
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NDD EasyOne Pro Operator's Manual

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new diagnostic design
EasyOne Pro/LAB Rev. 05
Operator's Manual V5.0
9000009_01
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

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Summary of Contents for NDD EasyOne Pro

  • Page 1 EasyOne Pro/LAB Rev. 05 Operator’s Manual V5.0 9000009_01 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch...

  • Page 2: Preface

     Revision history of the EasyOne Pro/LAB Operator’s Manual Identification and revision of the EasyOne Pro Respiratory Analysis System This revision V5.0 of the EasyOne Pro/LAB Operator’s Manual applies to EasyOne Pro Respiratory Analysis Systems with a revision number greater than Rev. 05.

  • Page 3: Intended Use Of The Easyone Pro Respiratory Analysis System

    EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals. EasyOne Pro/LAB can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. EasyOne Pro/LAB is used to conduct lung function measurements on adults...

  • Page 4: Legal Information

    Please make use of your local WEEE collection facilities to dispose of this product and otherwise observe all applicable requirements. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 4/171...

  • Page 5: Table Of Contents

    Connecting the components........21 Turning EasyOne Pro/LAB on and off ......25 About using the touchscreen .
  • Page 6 Escalating in case of a security breach ......37 Dealing with a lost or stolen EasyOne Pro/LAB ..... . . 38 Using EasyOne Pro/LAB securely –...
  • Page 7 Avoiding contamination while performing spirometry ....98 Cleaning instructions for EasyOne Pro/LAB ......99 Operator’s Manual V5.0 •...
  • Page 8 Adding patient data to the database of EasyOne Pro/LAB ... . . 100 Editing patient data with EasyOne Pro/LAB ......100 Merging two patient data records with EasyOne Pro/LAB.

  • Page 9: Ndd Medizintechnik Ag • Technoparkstrasse 1, 8005 Zurich, Switzerland • Www.ndd.ch

    13 Specifications and bibliography List of specifications for EasyOne Pro ......130 List of specifications for EasyOne Pro LAB .

  • Page 10: Safety Information

    Electric shock To avoid risk of electric shock, this equipment must only be connected to a grounded mains supply. Do not position EasyOne Pro/LAB in a way that makes it difficult to operate the disconnection device. Patient health Use only medical grade gases.
  • Page 11 False diagnosis EasyOne Pro/LAB can be damaged when dropped or during transport. Do an incoming inspection when you first receive EasyOne Pro/LAB. If you de- tect a damage, contact your EasyOne dealer or the ndd Servicing Department. Do not drop EasyOne Pro/LAB.

  • Page 12: Safety Information Regarding Electromagnetic Compatibility

    EasyOne Pro/LAB. Keep a distance of at least 30 cm (12 inches) to any part of EasyOne Pro/LAB. Increased emissions Accessories, transducers, and cables other than those specified by the manu-...

  • Page 13: About Requirements For Connections To External Devices

    EN 60601-1:2006 specifies the requirements for power outlet strips. Bear in mind that the touch currents may vary with the system configuration. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 13/171...

  • Page 14: List Of Applied Parts

    Instrument classification: Type BF applied part Universal Serial Bus (USB)—standard for connecting devices and data transfer, applies to cables and connectors Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 14/171...

  • Page 15: Introduction

    About the two products EasyOne Pro and EasyOne Pro LAB In the product family EasyOne Pro Respiratory Analysis System, there are two products, EasyOne Pro and EasyOne Pro LAB. EasyOne Pro LAB has the same functionality as EasyOne Pro, but in addition to that can perform the multi- breath washout test (MBW test) to determine the functional residual capacity (FRC).

  • Page 16: Introduction To The Easyone Pro Respiratory Analysis System

    Motor and valve unit spirette respiratory tube Flow sensor holder Power button Touchscreen  The EasyOne Pro Respiratory Analysis System Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 16/171...
  • Page 17 Connector for the flow sensor cable tests, EasyOne Pro LAB only) Connector for the patient tube  Ports and connectors of EasyOne Pro/LAB Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 17/171...
  • Page 18 The one-way valve can be used for multiple patients and must be replaced once a year. The one-way valve is designed to work accurately with EasyOne Pro/LAB. For reliable results, use only the original one-way valve manufactured by ndd.
  • Page 19 The DLCO barriette and the FRC barriette are designed to work accurately with EasyOne Pro/LAB. For reliable results, use only the original DLCO barriette and the original FRC barriette manufactured by ndd. The figures show how to insert the DLCO barriette and the FRC barriette.

  • Page 20: About Compatible Printers And Printer Setup

    FALSE DIAGNOSIS Non-original respiratory tubes can cause measurement error and false results. You must only use spirette respiratory tubes by the manufacturer ndd to assure accuracy, long-life, and full warranty coverage. List of order numbers and accessories for EasyOne Pro/LAB, 136...

  • Page 21: Connecting The Components

    Connector for the patient tube Connector for the flow sensor 1 Plug the power cable into the power port on the back of EasyOne Pro/LAB and into a power outlet. (B) 2 On the back of EasyOne Pro/LAB, connect the temperature and humidity sensor.
  • Page 22 You can slide in the holder when not in use. 4 On the side of EasyOne Pro/LAB, unscrew the dust cap.  Keep the dust cap in case you want to put EasyOne Pro/LAB in storage at a later point in time.
  • Page 23 6 With the white end, connect the patient tube to the motor and valve unit. First, fully insert the connector. Then, screw the coupling ring tight. 7 On the back of EasyOne Pro/LAB, connect the temperature and humidity sensor. (A) Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 ©...
  • Page 24 Introduction 8 On the side of EasyOne Pro/LAB, connect the flow sensor. (E) Postrequisite Check the gas tube connectors for leakage   To check the gas tube connector for leakages, 69 Application Note Connecting EasyOne Pro to a Network Application Notes for further information, 3...

  • Page 25: Turning Easyone Pro/Lab On And Off

    Introduction 3.2.4 Turning EasyOne Pro/LAB on and off EasyOne Pro/LAB has a mains switch on the back and a power button on the front. CAUTION DATA LOSS Do not turn off EasyOne Pro/LAB with the mains switch on the back without shutting EasyOne Pro/LAB down first.

  • Page 26: About Using The Touchscreen

    4 After the pressure has been released, choose OK.  EasyOne Pro/LAB shuts down. 5 Optionally, after EasyOne Pro/LAB has shut down, you can turn off the mains switch on the back.  Closing the gas valves and disconnecting the gas supply, 84...

  • Page 27: Overview Of The User Interface Of Easyone Pro/Lab

    Basic interface elements are used throughout EasyOne Pro/LAB for status information and for navigation in the menus. The main menu The main menu is the starting point when working with EasyOne Pro/LAB.  The main menu of EasyOne Pro/LAB The main menu displays the following icons: In the patients menu, you have access to patient data and also to the reports.
  • Page 28 With the menu area, you can navigate back to the main menu. The label and function of this area varies between menus. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 28/171...

  • Page 29: List Of Terms And Definitions

    Orders are related to EMR systems.  Terms and definitions Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 29/171...

  • Page 30: List Of Tests And Parameters

    BTPS factor used for expiration – BTPS BTPS factor used for inspiration – Cumulative expiratory volume Cumulative expiratory volume at 5%  Parameters Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 30/171...
  • Page 31 Ratio of FEV to FEV – /FVC Ratio of FEV to FVC – Ratio of FEV –  Parameters Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 31/171...
  • Page 32 Mean expiratory flow at 75% of vital capacity—synonymous with FEF Mean expiratory flow at 60% of vital capacity—synonymous with FEF  Parameters Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 32/171...
  • Page 33 Total lung capacity, based on multi breath washout test Total lung capacity, based on single breath test TLCO CO diffusion capacity mmol/min/kPa  Parameters Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 33/171...
  • Page 34 Inspired Volume Tidal volume VT/FRC Ratio of VT to FRC – VT/kg Tidal volume per kilogram mL/kg  Parameters Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 34/171...

  • Page 35: List Of Abbreviations

    Universal Serial Bus (USB)—standard for connecting devices and data transfer, applies to cables and connectors  Abbreviations About sources for predicted normal values The available predicted normal values for EasyOne Pro/LAB are updated as required through software updates. You can find the currently used sources for predicted normal values in the document below.

  • Page 36: Cybersecurity

    An antivirus software and a firewall are pre-installed on EasyOne Pro/LAB. EasyOne Pro/LAB can be connected to a network for various purposes, but can also function stand-alone without network access. The file-based database is encrypted.

  • Page 37: About Periodical Software Updates And Patches

    When using a file-based database EasyOne Pro/LAB includes a separate backup storage that automatically stores the current database. The backup is performed each time EasyOne Pro/ LAB is shut down. In addition, the manufacturer recommends that you regularly backup the database manually to a different storage device and that you store this additional backup in a separate location.

  • Page 38: Dealing With A Lost Or Stolen Easyone Pro/Lab

    Cybersecurity Dealing with a lost or stolen EasyOne Pro/LAB In case EasyOne Pro/LAB has been lost or stolen, do the following: Prerequisite The manufacturer strongly recommends that you activate user handling  in order to prevent unauthorized persons from accessing the data stored on EasyOne Pro/LAB About user handling and the default password, 105...

  • Page 39: Using Easyone Pro/Lab Securely - General Guidelines

    User Handling check box. h) Choose Save.  User handling is activated. Now, users must log in to use EasyOne Pro/ LAB. 2 To prevent unauthorized access when EasyOne Pro/LAB is unattended, activate automatic log off. To activate automatic log off, do the following: a) Choose Utilities >...

  • Page 40: Connectivity And Data Exchange

    Connectivity and data exchange For data exchange, you can connect EasyOne products with the EasyOne Connect PC software. In addition, you can interface EasyOne Connect and EasyOne Pro/LAB with the information system in your hospital or practice. About connectivity between EasyOne products Easy...

  • Page 41: About Integration Of Emr Systems

    The order workflow For the order workflow, EasyOne Connect or EasyOne Pro/LAB and your EMR system are connected over the network and exchange so-called orders. In an additional menu on the main menu, EasyOne Connect and EasyOne Pro/LAB display the orders from your EMR system.

  • Page 42: Overview Of The Integration Process

    Connectivity and data exchange The direct-start workflow Your EMR system is either connected to EasyOne Connect or EasyOne Pro/LAB over the network, or your EMR system is installed on the same PC as EasyOne Connect. Either way, your EMR system can interact and launch EasyOne Connect or EasyOne Pro/LAB directly.

  • Page 43: Overview Of The Plug-Ins For Emr Systems

    Alternatively, you can use the direct-start workflow and initiate spirometry from your EMR system. Supported Features EasyOne Connect and EasyOne Pro/LAB support the following features of HL7: • Receiving patient demographics from your EMR system • Sending test results to your EMR system •...

  • Page 44: About The Xml File Exchange Plug-In

    EMR plug-ins to interface with any EMR system.  Software Developer Guide SDK – ndd EMR plug-in Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 44/171...

  • Page 45: Working With Your Emr System

    5.2.5.1 Processing orders from your EMR system If you have interfaced your EMR system with EasyOne Connect or EasyOne Pro/ LAB through the HL7 plug-in or a custom EMR plug-in, you can access the patient data of your EMR system in the orders menu in EasyOne Connect or on EasyOne Pro/LAB.

  • Page 46: Initiating A Spirometry Test With The Direct-Start Workflow

    8 Perform spirometry with the patient. 9 If required, print an additional report from the test result screen. 10 Choose Finish.  The test results are sent to your EMR system, and EasyOne Pro/LAB is closed automatically.  Your EMR system receives the test results.

  • Page 47: Sending Individual Test Results To Your Emr System

    2 Select a patient. 3 Choose History. 4 Choose the button.  Hidden buttons are revealed. 5 Choose Send to EMR. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 47/171...

  • Page 48: Performing Lung Function Tests

    Measurement errors can cause false diagnosis. Check the device for visible damage before on-site installation and before us- age. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 48/171...

  • Page 49: About Preparation Of Spirometry And Instructions For The Patient

    After a break, you can still pick up a test and add trials, or print the report. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 49/171...

  • Page 50: About Quality Messages For Trials And Quality Grades For Tests

    C is sufficient.  List of quality messages and quality grades, 86 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 50/171...

  • Page 51: About Posts And Bronchodilation

    For an FVL test, an MVV test, or an SVC test, a nose clip is required.  Prerequisites You have added the patient data to the database of EasyOne Pro/LAB.  Or the patient data is already in the database of EasyOne Pro/LAB.
  • Page 52 If the wrapper of the spirette has a defect, discard the spirette, take another spirette, and visually check the wrapper of the new spirette again for defects. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 52/171...
  • Page 53  For hygiene reasons, grip the partly unwrapped spirette only with the wrapper at the mouthpiece. Do not touch the spirette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 53/171...
  • Page 54 Proceed with step 9. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 54/171...
  • Page 55  The patient must not block the opening with the tongue or teeth or bite down excessively on the spirette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 55/171...
  • Page 56 1 Grip the spirette with the wrapper again and pull the spirette out of the spirette holder. Do not touch the spirette. 2 Dispose of the spirette together with the wrapper. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 56/171...
  • Page 57 EasyOne Pro/LAB while cleaning. To clean the flow sensor, do not immerse the flow sensor into any fluid. To clean the flow sensor of EasyOne Pro/LAB and to disinfect your hands after each patient, do the following: a) Clean the outside of the flow sensor as described in the cleaning...

  • Page 58: Performing A Bronchial Provocation Test

     Prerequisites You have configured the appropriate protocol for provocation tests.  You have added the patient data to the database of EasyOne Pro/LAB.  Or the patient data is already in the database of EasyOne Pro/LAB.  You are wearing disposable gloves.
  • Page 59 If the wrapper of the spirette has a defect, discard the spirette, take another spirette, and visually check the wrapper of the new spirette again for defects. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 59/171...
  • Page 60  For hygiene reasons, grip the partly unwrapped spirette only with the wrapper at the mouthpiece. Do not touch the spirette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 60/171...
  • Page 61  If you choose to adjust the values indicated by the temperature and humidity sensor, you must enter the environment temperature within 1°C or 1.8°F accuracy for the FVL test. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 61/171...
  • Page 62  If the trial is not acceptable, a yellow or red quality message is displayed suggesting how to improve the breathing maneuver. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 62/171...
  • Page 63 1 Grip the spirette with the wrapper again and pull the spirette out of the spirette holder. Do not touch the spirette. 2 Dispose of the spirette together with the wrapper. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 63/171...
  • Page 64 EasyOne Pro/LAB while cleaning. To clean the flow sensor, do not immerse the flow sensor into any fluid. To clean the flow sensor of EasyOne Pro/LAB and to disinfect your hands after each patient, do the following: a) Clean the outside of the flow sensor as described in the cleaning...

  • Page 65: Performing Lung Function Tests With Gas Supply

    4 Slide the motor and valve unit forward, and release the button.  The interlock is engaged.  Performing a DLCO test, 70 Performing an MBW test, 77 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 65/171...

  • Page 66: Dismount The Motor And Valve Unit From The Flow Sensor

     outlet Description of test gas requirements, 136 The procedure for connecting EasyOne Pro/LAB to the gas supply is the same for gas cylinders and for a central gas supply. Also, the gas tubes and connectors are the same. The connectors for the gas supply comply with the standard Diameter Index Safety System.
  • Page 67 LAB do the following: a) On the gas tube, retract and hold the nut of the connector. b) Connect the gas tube to the correct port of EasyOne Pro/LAB, which is depicted below. c) Fasten the nut of the connector.
  • Page 68 MBW tests 2 On the gas cylinder fittings, connect the other end of the gas tube to the port E. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 68/171...
  • Page 69 Reconnect the gas supply properly. d) Open the gas valves again. e) Repeat steps 1 to 3 until you find no more leakages. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 69/171...

  • Page 70: Contraindications For A Dlco Test

     A nose clip.  Prerequisites You have added the patient data to the database of EasyOne Pro/LAB.  Or the patient data is already in the database of EasyOne Pro/LAB.  Performing an SVC test before a DLCO test is recommended.
  • Page 71 DLCO barriette, take another spirette or DLCO barriette, and visually check the wrapper of the new spirette or DLCO barriette for defects again. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 71/171...
  • Page 72  For hygiene reasons, grip the partly unwrapped spirette only with the wrapper at the mouthpiece. Do not touch the spirette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 72/171...
  • Page 73  The DLCO test screen is displayed with a pop-up window that asks you to insert the DLCO barriette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 73/171...
  • Page 74 7 When the patient inhales, encourage the patient to fully inhale.  In the colored status bar, Hold Your Breath is displayed. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 74/171...
  • Page 75 Decide whether the test quality is sufficient or not. c) If necessary, add a trial and repeat the procedure To perform the DLCO breathing maneuver. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 75/171...
  • Page 76 EasyOne Pro/LAB while cleaning. To clean the flow sensor, do not immerse the flow sensor into any fluid. To clean the flow sensor of EasyOne Pro/LAB and to disinfect your hands after each patient, do the following: a) Clean the outside of the flow sensor as described in the cleaning...

  • Page 77: Performing An Mbw Test

    A new FRC barriette for each patient  A nose clip  Prerequisites You have added the patient data to the database of EasyOne Pro/LAB.  Or the patient data is already in the database of EasyOne Pro/LAB.  The patient has performed an SVC test.
  • Page 78 FRC barriette, take another spirette or FRC barriette, and visually check the wrapper of the new spirette or FRC barriette for defects again. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 78/171...
  • Page 79  For hygiene reasons, grip the partly unwrapped spirette only with the wrapper at the mouthpiece. Do not touch the spirette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 79/171...
  • Page 80  The MBW test screen is displayed with a pop-up window that asks you to insert the FRC barriette. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 80/171...
  • Page 81  If the trial is not acceptable, a yellow or red quality message is displayed suggesting how to improve the breathing maneuver. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 81/171...
  • Page 82 1 Grip the spirette with the wrapper around again and pull the spirette out of the spirette holder. Do not touch the spirette. 2 Dispose of the spirette together with the wrapper. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 82/171...
  • Page 83 EasyOne Pro/LAB while cleaning. To clean the flow sensor, do not immerse the flow sensor into any fluid. To clean the flow sensor of EasyOne Pro/LAB and to disinfect your hands after each patient, do the following: a) Clean the outside of the flow sensor as described in the cleaning...

  • Page 84: Closing The Gas Valves And Disconnecting The Gas Supply

    This way, you do not have to find the right pressure level on the secondary side the next time. If you want to move EasyOne Pro/LAB, you must close both valves, and you can disconnect the gas tubes.

  • Page 85: About Interpreting Results

    On the gas tube, retract and hold the nut of the connector. c) Disconnect the gas tube from the port E. 4 On the back of EasyOne Pro/LAB, disconnect the other end of the gas tube from EasyOne Pro/LAB.

  • Page 86: List Of Quality Messages And Quality Grades

    The problem can be resolved by checking EasyOne Pro/LAB. The following table gives an overview of potential quality messages. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 86/171...
  • Page 87 Retry maneuver and follow the instructions that are shown during the maneuver. Complete inspiration and expiration are required.  Quality messages for trials Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 87/171...
  • Page 88 Check complete gas connection and valve assembly, and that test is performed correctly.  Quality messages for trials Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 88/171...
  • Page 89 Check complete gas connection and if patient tube (Maintenance kit) needs to be replaced. Contact support if error persists.  Quality messages for trials Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 89/171...
  • Page 90 Unable to detect maneuver. Retry maneuver and follow the instructions that are shown during the maneuver.  Quality messages for trials Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 90/171...
  • Page 91 No start of washout detected. Follow the instructions that are shown during the maneuver.  Quality messages for trials Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 91/171...

  • Page 92: List Of Quality Grades For Tests

    Quality message: Only one acceptable trial No acceptable trial available  Quality grades for the FVC test, the FVL test, and the OSHA test Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 92/171...
  • Page 93 1 acceptable trial or multiple trials with LCI variability ≥10% or FRC variability ≥ 25% no acceptable trial  Quality grades for the MBW test Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 93/171...

  • Page 94: Breathing Maneuvers For All Available Tests

     If the trial is not acceptable, a yellow or red quality message is displayed suggesting how to improve the breathing maneuver.  Performing lung function tests, 48 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 94/171...

  • Page 95: Performing The Breathing Maneuver For The Fvl Test

     If the trial has not been acceptable, a yellow or red quality message is displayed suggesting how to improve the breathing maneuver.  Performing lung function tests, 48 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 95/171...

  • Page 96: Performing The Breathing Maneuver For The Mvv Test

    5 Tell the patient to take the spirette out of the mouth and to breathe normally again.  Performing lung function tests, 48 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 96/171...

  • Page 97: Performing The Breathing Maneuver For The Svc Test

     If the trial is not acceptable, a yellow or red quality message is displayed suggesting how to improve the breathing maneuver.  Performing lung function tests, 48 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 97/171...

  • Page 98: Hygiene And Cleaning

    EasyOne Pro/LAB while cleaning. To clean the flow sensor, do not immerse the flow sensor into any fluid. To clean the flow sensor of EasyOne Pro/LAB and to disinfect your hands after each patient, do the following: a) Clean the outside of the flow sensor as described in the cleaning...

  • Page 99: Cleaning Instructions For Easyone Pro/Lab

    Hygiene and cleaning Cleaning instructions for EasyOne Pro/LAB Some parts of EasyOne Pro/LAB are sensitive to certain disinfectants or fluids. To prevent damage to EasyOne Pro/LAB, follow these cleaning instructions. CAUTION ELECTRIC SHOCK, FAILURE OF EASYONE PRO/LAB, AND FALSE DIAGNOSIS Make sure that no fluid penetrates the inside of the flow sensor or of EasyOne Pro/LAB while cleaning.

  • Page 100: Working With Patient Data And Reports

     You must fill out those fields that are marked with an asterisk (*). 5 In all other fields, enter additional patient data if necessary. 6 Choose OK. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 100/171...

  • Page 101: Merging Two Patient Data Records With Easyone Pro/Lab

    EasyOne Pro/LAB, you are prompted for the default password. Proceed with step 4.  If user handling is active, that is if you did have to login to EasyOne Pro/ LAB, you are not prompted for a password. A confirmation window is displayed immediately.

  • Page 102: Viewing And Printing Reports With Easyone Pro/Lab

    At the bottom of the trend screen, you can select four parameters to be displayed at the same time. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 102/171...

  • Page 103: Assessing Tests Retrospectively And Entering Comments With Easyone Pro/Lab

    3 Enter your comment and choose Save.  Your comment is displayed on the result screen.  About user handling and the default password, 105 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 103/171...

  • Page 104: About Exporting Comprehensive Data From Easyone Pro/Lab

    Utilities > Advanced > Export Enter the default password: 8005 On the back of EasyOne Pro/LAB, you must connect a USB flash drive. This export is the most comprehensive export function in EasyOne Pro/LAB. You can select which data to include in the export.

  • Page 105: Configuration

    Instead, logs include the respective user. Therefore, sensitive changes can be traced back to individual users. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 105/171...

  • Page 106: Description Of General Configurations

    To create a new empty database—you must choose between a local file-based database or an SQL-server-based database. Select button In a new window, to select a different database file or connect EasyOne Pro/LAB as a database client to a database server. SQL database servers are supported. Import button To import a second database file into the currently active database—both databases...

  • Page 107: Utilities > Configuration > General > System Settings

    7 To save the changes, choose OK. 8 To discard the changes, choose Cancel.  About user handling and the default password, 105 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 107/171...

  • Page 108: Description Of Test Configurations For Easyone Pro/Lab

    MBW tests enter a value between 1 and 99 in the text fields Number of Trials Forced/Slow, DLCO, and MBW. The default value is 99 in each case. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 108/171...

  • Page 109: Utilities > Configuration > Test > Predicted

    Therefore, the predicted normal values are subject to change. These changes are delivered to you via software updates. Updated information is published in an Application Note on the ndd website. Application Note Reference Predicted Normal Values Application Notes for further information, 3...
  • Page 110  NLHEP interpretation algorithm The diagram above shows how the interpretation for NLHEP is determined, according to Ferguson (2000/NLHEP) [4]. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 110/171...
  • Page 111 GOLD/Hardie 2008 is determined, according to GOLD (2003) [11] and Hardie (2002) [12]. The smoker status is not part of the GOLD/Hardie standard of 2008, only of 2003. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 111/171...
  • Page 112 The diagram above shows how the interpretation for NICE is determined. The NICE interpretation is mainly used in the UK. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 112/171...

  • Page 113: Recalculating Predicted Values Of Previous Test Results

    5 In the information window, review and confirm the selected changes.  All records in the database are updated. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 113/171...

  • Page 114: Utilities > Configuration > Test > Fvc / Fvl

    FVL, Ex./In. determines whether the bronchial provocation test is performed using an FVC test or an FVL test. Second, if you have integrated EasyOne Pro/LAB with your EMR system and if you use the GDT plug-in, the setting FVC, Ex. only FVL, Ex./In.

  • Page 115: Utilities > Configuration > Test > Svc

    Enter the test gas concentrations as specified on the gas cylinders into the fields CO, . The test gas concentrations must be within the range indicated in parentheses. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 115/171...

  • Page 116: Utilities > Configuration > Test > Frc (Mbw)

    To display the tracer curve with a linear scaling, choose Linear. To display the trace curve with a semi-logarithmic scaling choose Semi-Log. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 116/171...

  • Page 117: Utilities > Configuration > Test > Calcheck

    Different protocols for the provocation test are available using Mannitol and Methacholine as provocative agents. Choose the protocol from the drop-down list. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 117/171...

  • Page 118: Loading And Selecting A Custom Report Layout Of Easyone Pro/Lab

    Loading and selecting a custom report layout of EasyOne Pro/LAB You can load custom report layouts according to your requirements. For easy identification you can rename the report layouts. Your EasyOne Pro/LAB dealer or the ndd Servicing Department can assist you in creating a custom report layout. Prerequisite You have created or received a report layout file with an *.repx file...

  • Page 119: Description Of Environment Configurations

    • Provocation test (if the FVL test is configured for the provocation test) • DLCO test • MBW test Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 119/171...

  • Page 120: Performing A Software Update

    The software update is delivered as a ZIP file. Do not unzip this file on a PC. The file will automatically be unzipped on EasyOne Pro/LAB.  To perform a software update 1 On the back of EasyOne Pro/LAB, connect the USB flash drive to a USB port. 2 Choose Utilities >...
  • Page 121 Calibration check, 122 Checking for correct operation of EasyOne Pro/LAB, 127  Contact information, 4 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 121/171...

  • Page 122: Calibration Check

    Calibration check Calibration check CAUTION FALSE DIAGNOSIS For unforeseen reasons, malfunction of EasyOne Pro/LAB can lead to false re- sults and false diagnosis. Perform calibration checks periodically. Calibration check, 122 Checking for correct operation of EasyOne Pro/LAB, 127 11.1 Performing a calibration check...
  • Page 123  Calibration checks are filed in the history menu as patients with the last name Calibration Check.  List of troubleshooting solutions, 127 Contact information, 4 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 123/171...

  • Page 124: Performing Biological Quality Control

    It is practical to choose subjects in your practice or hospital who are available long-term. If you suspect a problem with EasyOne Pro/LAB, you can perform a test promptly on one of the known subjects and see whether the results fall within the expected range or not.

  • Page 125: Performing And Assessing Biological Quality Control

    3 Evaluate the quality criteria for biological quality control. 4 To print a report, choose the reports button.  Performing lung function tests, 48 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 125/171...

  • Page 126: List Of Quality Criteria For Biological Quality Control

     Performing a calibration check, 122 Performing lung function tests with gas supply, 65 About the trend view with EasyOne Pro/LAB, 102 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 126/171...

  • Page 127: Servicing And Troubleshooting

    2 Perform a spirometry test on yourself or on another known subject. 3 Check the results of steps 1 and 2 for plausibility. a) If the results of steps 1 and 2 are plausible, EasyOne Pro/LAB is operating correctly. b) If the results of steps 1 and 2 are not plausible, troubleshoot.

  • Page 128: About Reactivating Easyone Pro/Lab After Storage

    EasyOne Pro/LAB can export logging information. The ndd Servicing Department or your own technical staff may require logging information to determine the source of a problem. 1 On the back of EasyOne Pro/LAB, connect the USB flash drive to a USB port. 2 Choose Utilities >...

  • Page 129: Creating Screenshots

    On PCs, the screenshot can be displayed and sent like a photo. 1 On the back of EasyOne Pro/LAB, connect a USB flash drive to a USB port. 2 Navigate to the screen that you want to capture.

  • Page 130: Specifications And Bibliography

    Specifications and bibliography Specifications and bibliography 13.1 List of specifications for EasyOne Pro These specifications of the EasyOne Pro model differ slightly from the specifications of the EasyOne Pro LAB model. List of specifications for EasyOne Pro LAB, 133 Size 27 x 33.5 x 27 centimeters (10.6 x 13.2 x 10.6 inches)
  • Page 131 ISO 23747 Anesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans CE marked, EC declaration of conformity, see on the ndd website under “Certificates” FDA 510(k) market clearance Associations...
  • Page 132  List of tests and parameters, 30 Application Note Reference Predicted Normal Values Application Notes for further information, 3 Contact information, 4 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 132/171...

  • Page 133: List Of Specifications For Easyone Pro Lab

    Specifications and bibliography 13.2 List of specifications for EasyOne Pro LAB These specifications of the EasyOne Pro LAB model differ slightly from the specifications of the EasyOne Pro model. List of specifications for EasyOne Pro, 130 Size 27 x 33.5 x 27 centimeters (10.6 x 13.2 x 10.6 inches) Weight 8.0 kilograms (17.65 pounds)
  • Page 134 0.3% carbon monoxide, accuracy ±10% 18% to 25% oxygen, balance nitrogen MBW gas 100% O specification  Specifications for EasyOne Pro/LAB Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 134/171...

  • Page 135: List Of Tests And Parameters

    ISO 23747 Anesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans CE marked, EC declaration of conformity, see on the ndd website under “Certificates” FDA 510(k) market clearance Associations...

  • Page 136: Description Of Test Gas Requirements

    FRC barriette for EasyOne Pro Lab, box of 80pcs 3150-2 calibration syringe 3 L (includes a spirette cal check adapter) 2030-2 Annual Replacement Parts Kit EasyOne Pro and EasyOne Pro Lab (consisting of: Filter Pack, Patient 3000-50.50SP Tube, One-way Valve, Gas Overflow Valve) Flow sensor 3000-50.5SP...

  • Page 137: List Of Bibliographic References

    American Journal of Respiratory and Critical Care Medicine, Vol 175, 2007, pp 1304–1345.  Application Note Reference Predicted Normal Values Application Notes for further information, 3 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 137/171...

  • Page 138: Index

    EasyOne Pro biological quality control ......124 EasyOne Pro LAB ..........15 Direct-start workflow, EMR systems ....46 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 138/171...
  • Page 139 ....... 109 quality grades ..........93 Interval ............29 quality messages ........86 Introduction ........... 15 see also, tests Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 139/171...
  • Page 140 ........115 menu ............45 reports ............ 102 order workflow, EMR systems ...... 45 Problems, see troubleshooting processing ..........45 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 140/171...
  • Page 141 ....117 system settings ........107 Technician, user group ........106 Test menu ............27 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 141/171...
  • Page 142 ..........104 quality messages ........86 XML file exchange plug-in ....44 selecting calibration check type ....117 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 142/171...

  • Page 143: A Appendix

    Appendix List of used tools and frameworks in the EasyOne Pro/LAB software The following tools and frameworks are part of the EasyOne Pro/LAB software. • Microsoft Windows 8 Embedded Standard Microsoft Software License Agreement for Windows Embedded 8 Standard, 144...

  • Page 144: Microsoft Software License Agreement For Windows Embedded 8 Standard

    The Additional Terms contain a binding arbitration clause and class action waiver. If you live in the United States, these affect your rights to resolve a dispute with ndd Medizintechnik AG, or with Microsoft, and you should read them carefully.
  • Page 145 Software that provides consumer or business tasks or processes may not run on the licensed device. This includes word processing, spreadsheet, database, scheduling and personal finance software. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 145/171...
  • Page 146 “Dispute” will be given the broadest possible meaning allowable under law. b. Notice of Dispute. In the event of a dispute, you or ndd Medizintechnik AG must give the other a Notice of Dispute, which is a written statement of the name, address, and contact information of the party giving it, the facts giving rise to the dispute, and the relief requested.
  • Page 147 You and ndd Medizintechnik AG will attempt to resolve any dispute through informal negotiation within 60 days from the date the Notice of Dispute is sent. After 60 days, you or ndd Medizintechnik AG may commence arbitration. c. Small claims court. You may also litigate any dispute in small claims court in your county of residence or the ndd Medizintechnik AG’s...
  • Page 148 6399. You may commence an arbitration or small claims court case against Microsoft in your county of residence or King County, Washington. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 148/171...
  • Page 149 Some Internet-based features may be delivered at a later date via Microsoft’s Windows Update service—if, for example, you acquire an application that relies on one of those services. ndd Medizintechnik AG may have elected to turn on one or more of the following features in the licensed device.
  • Page 150 An administrator can disable this update feature. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 150/171...
  • Page 151 Windows partners diagnose problems in the software and provide solutions. Not all problems will have a solution but when a solution is Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 151/171...
  • Page 152 You can turn this feature off or choose your preferred Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 152/171...
  • Page 153 You may only obtain updates or upgrades for the software from Microsoft or authorized sources. You may not be able to obtain certain updates or upgrades from ndd Medizintechnik AG, or Microsoft, if your copy of the software is improperly licensed. Certain upgrades, support, and other services may be offered only to users of genuine Microsoft software.
  • Page 154 15. REFUND PROCEDURES Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 154/171...
  • Page 155 Appendix If you are seeking a refund, contact ndd Medizintechnik AG to determine its return policy for a refund or credit. You must comply with that policy, which might require you to return the software with the entire licensed device on which the software is installed for a refund.

  • Page 156: Gnu General Public License Version 3, 29 June 2007 For Sumatra Pdf Reader

    Therefore, we have designed this version of the GPL to prohibit Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 156/171...
  • Page 157 The “source code” for a work means the preferred form of the work for making modifications to it. “Object code” means any non-source form of a work. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 157/171...
  • Page 158 Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 158/171...
  • Page 159 Appropriate Legal Notices; however, if the Program has interactive interfaces that do not display Appropriate Legal Notices, your work need not make them do so. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 159/171...
  • Page 160 Corresponding Source of the work are being offered to the general public at no charge under subsection 6d. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 160/171...
  • Page 161 If additional permissions apply only to part of the Program, that part may be used separately under those permissions, but the Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 161/171...
  • Page 162 You may not propagate or modify a covered work except as expressly provided under this License. Any attempt otherwise to propagate or modify it is void, Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 162/171...
  • Page 163 Program or any portion of it. 11. Patents. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 163/171...
  • Page 164 (a) in connection with copies of the covered work conveyed by you (or Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 164/171...
  • Page 165 However, no additional obligations are imposed on any author or copyright holder as a result of your choosing to follow a later version. 15. Disclaimer of Warranty. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 165/171...
  • Page 166 You should have received a copy of the GNU General Public License along with this program. If not, see <http://www.gnu.org/licenses/>. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 166/171...
  • Page 167 If this is what you want to do, use the GNU Lesser General Public License instead of this License. But first, please read <http://www.gnu.org/ philosophy/why-not-lgpl.html>. Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 167/171...

  • Page 168: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) A.4.1 General A.4.1.1 Environment See:  Intended use of the EasyOne Pro Respiratory Analysis System, 3 A.4.1.2 EMC conformance EasyOne Pro/LAB is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 3 edition (see the following tables) and IEC 60601-1-2:2014 4 Edition (according clause 7 and 8.9, tables 4 to 9).

  • Page 169: Electromagnetic Emission

    Electromagnetic emission Guidance and manufacturer’s declaration – electromagnetic emissions EasyOne Pro/LAB is intended for use in the electromagnetic environment specified below. The user of EasyOne Pro/LAB should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance...
  • Page 170 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EasyOne Pro/LAB is used exceeds the applicable RF compliance level above, the EasyOne Pro/LAB should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EasyOne Pro/LAB.
  • Page 171  Recommended separation distances between portable and mobile RF communications equipment and EasyOne Pro/ Operator’s Manual V5.0 • EasyOne Pro/LAB Rev. 05 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch...

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