NDD EasyOne Air Operator's Manual
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EasyOne Air
Operator's Manual V1.1
9000007_01
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

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Summary of Contents for NDD EasyOne Air

  • Page 1 EasyOne Air Operator’s Manual V1.1 9000007_01 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch...
  • Page 2: Revision History Of The Easyone Air Operator's Manual

    Identification and revision of the EasyOne Air spirometer This revision V1.1 of the EasyOne Air Operator’s Manual applies to EasyOne Air with a serial number greater than 1,000,000 and with a firmware version greater than V1.9.0. If you are in doubt whether this revision of the Operator’s Manual applies to your particular EasyOne Air sensor, please contact the ndd Servicing Department.
  • Page 3: Intended Audience Of This Operator's Manual

    Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 3/144...
  • Page 4: About Electromagnetic Interference

    Please make use of your local WEEE collection facilities to dispose of this product and otherwise observe all applicable requirements. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 4/144...
  • Page 5: Table Of Contents

    Setting up the physical components ....... 20 Setting up the EasyOne Air spirometer ......24 Installing or updating the EasyOne Connect software on your PC .
  • Page 6 Overview of EasyOne Air ........
  • Page 7 Performing a bronchial provocation test using EasyOne Connect in combination with EasyOne Air ....... . 71 About interpreting results.
  • Page 8 Configuration of EasyOne Air ........
  • Page 9 14 Specifications and bibliography List of specifications for EasyOne Air ......125 List of specifications for the lithium-ion battery of EasyOne Air.
  • Page 10 Electromagnetic immunity ........142 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 10/144...
  • Page 11: Classification

    IEC 60950-1 standard for the electrical safety of IT equipment. Patient health Inadequate qualification of personnel who operate EasyOne Air can put the hazard patient’s health at risk. The patient may suffer an asthma attack or a bronchospasm while performing spirometry.
  • Page 12 For preventive measures, make sure that the device is not used near flamma- ble gases (for example, anesthetic agents). If not in daily use, remove the battery from EasyOne Air and store the battery in the original packaging. False diagnosis Environment conditions outside the range described in the specifications can cause measurement errors.
  • Page 13 Install anti-virus software on your PC. Malfunction Damaged components can lead to false results. Make sure that no liquid penetrates into EasyOne Air, for example through the battery compartment or the USB port. Leakage of acids Do not connect the battery improperly.
  • Page 14: Safety Information Regarding Electromagnetic Compatibility

    EasyOne Air. Keep a distance of at least 30 cm (12 inches) to any part of EasyOne Air. Increased emissions Accessories, transducers, and cables other than those specified by the manu-...
  • Page 15: About Requirements For Connections To External Devices

    Safety information About requirements for connections to external devices EasyOne Connect is installed on a PC or laptop, to which EasyOne Air is connected via the cradle or wirelessly. The PC or laptop is not part of the equipment supplied by the manufacturer and is considered a requisite accessory that is necessary to use EasyOne Air with the PC software EasyOne Connect.
  • Page 16: List Of Equipment Icons

    Universal Serial Bus (USB)—standard for data transfer, connecting devices, and battery charging, applies to cables and connectors Battery Serial number Batch code Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 16/144...
  • Page 17: List Of Box Contents

    The box contains the following items: EasyOne Flow Tube respiratory tubes EasyOne Air spirometer  Box contents – top inlay Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 17/144...
  • Page 18 USB flash drive 2x USB cable Nose clip ndd power supply Cradle  Box contents – bottom inlay Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 18/144...
  • Page 19: About Compatible Printers

     Description of print settings of EasyOne Air, 100 Setting up the physical components, 20 Application Note Printer Compatibility List Application Notes for further information, 3 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 19/144...
  • Page 20: Setting Up The Physical Components

    1 Unpack EasyOne Air and the battery. 2 Unlock and open the battery compartment by turning the lock screw clockwise. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 20/144...
  • Page 21 First-time setup 3 Insert the battery into the battery compartment of EasyOne Air.  The battery fits easily into the compartment. If the battery does not seem to fit, check the correct insert direction. Do not apply force. 4 Close and lock the battery compartment by turning the lock screw counterclockwise.
  • Page 22  You can connect the cradle either to a PC or to a printer. If you connect the cradle to a PC, you can use EasyOne Connect to print. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 22/144...
  • Page 23 9 For charging EasyOne Air, always connect the ndd power supply: a) Plug the ndd power supply into a power outlet. b) Connect the cable of the ndd power supply to the right USB port of the cradle (marked with the plug icon).
  • Page 24: Setting Up The Easyone Air Spirometer

     If the battery is removed for more than 8 hours, your need to reenter date and time.  Configuration of EasyOne Air, 93 Description of print settings of EasyOne Air, 100 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 24/144...
  • Page 25: Installing Or Updating The Easyone Connect Software On Your Pc

    Installing or updating the EasyOne Connect software on your PC The procedure for installing EasyOne Connect is the same as for updating EasyOne Connect. If EasyOne Connect is already installed on your PC, the ndd SmartInstaller performs an update. Prerequisite Your PC meets the system requirements for EasyOne Connect.
  • Page 26: Introduction

    USB port to connect to the cradle Lock screw for battery compartment Battery compartment  Bottom-view of EasyOne Air Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 26/144...
  • Page 27 Introduction When EasyOne Air is turned on and not in use, the screensaver and automatic power-off function are activated to save battery power. You can change the default configuration in the following menu: > > > Screensaver after Power-off after A low battery message will alert you when battery power falls below 10%.
  • Page 28: About Using The Touchscreen

    EasyOne Air is compliant to the Health Insurance Portability and Accountability Act. Access to EasyOne Air is password-protected. The internal database of EasyOne Air is encrypted. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 28/144...
  • Page 29 Introduction The home screen The home screen is the starting point when working with EasyOne Air.  The home screen of EasyOne Air The home screen displays the following icons: This icon is a shortcut to the most commonly performed test, the FVC test.
  • Page 30 In the update menu, you can perform firmware updates. In the backup menu, you can backup the patient database, results and configurations. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 30/144...
  • Page 31 In the print settings menu, you can configure the printer that is connected to the cradle. In the factory reset menu, you can reset the configuration of EasyOne Air to its delivery status. However, the patient data will not be deleted. Configuration of EasyOne Air, 93...
  • Page 32 The charging level is at about 50%. Indicates that EasyOne Air is connected to a power supply, but cannot charge. Check whether EasyOne Air is connected to the ndd power supply or to a different USB power source. Only use the ndd power supply.
  • Page 33: Introduction To The Easyone Connect Software

    EasyOne Connect is especially helpful to work with patient data and to evaluate results because you can use a full-size PC monitor and keyboard. If you want to perform spirometry with EasyOne Air stand-alone, for example off-site, EasyOne Connect enables you to enter all relevant patient data beforehand and synchronize that data to EasyOne Air.
  • Page 34: Overview Of The User Interface Of Easyone Connect

    In the utilities menu, you can configure EasyOne Connect and perform calibration checks and have access to settings and database functionalities. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 34/144...
  • Page 35: List Of Terms And Definitions

    A post is performed after the patient is treated with a bronchodilator. Prior to the medication, the same test has been performed to be compared with the post.  Terms and definitions Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 35/144...
  • Page 36: List Of Tests And Parameters

    Forced expiratory time Forced expiratory time between FEF and FEF 25-75 Forced expiratory volume after 0.25 seconds  Parameters Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 36/144...
  • Page 37 Mean inspiratory flow at 25% of vital capacity—synonymous with FIF MMEF Mean mid-expiratory flow—synonymous with FEF 25-75 Maximum voluntary ventilation L/min  Parameters Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 37/144...
  • Page 38 Inspiratory vital capacity, from slow inspiration Highest VC value from all trials of one test Tidal volume  Parameters Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 38/144...
  • Page 39: List Of Abbreviations

     Abbreviations About sources for predicted normal values The available predicted normal values for EasyOne Air are updated as required through software updates. You can find the currently used sources for predicted normal values in the document below.
  • Page 40: Cybersecurity

    • Passwords should be renewed after 90 days.  About user handling and the default password of EasyOne Connect, 105 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 40/144...
  • Page 41: About Periodical Software Updates And Patches

    2 Follow all other necessary procedures for a security breach as specified by your institution’s IT department. 3 If you are uncertain whether EasyOne Air has been compromised, contact the ndd Servicing Department. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect ©...
  • Page 42: Dealing With A Lost Or Stolen Easyone Air Or Pc

    Cybersecurity Dealing with a lost or stolen EasyOne Air or PC In case EasyOne Air or the PC that EasyOne Connect is installed on has been lost or stolen, do the following: Prerequisite The manufacturer strongly recommends that you activate user handling ...
  • Page 43 Choose Save.  After the period that you have set, EasyOne Air is locked and users must log in again. 3 Only use network file transfer (pdf, HL7, XML, etc.) in trusted and secured network environments.
  • Page 44: Connectivity And Data Exchange

    PC with EasyOne Connect or on any EasyOne Pro/LAB. Access to the server- based database is password-protected and requires a Microsoft Active Directory user account. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 44/144...
  • Page 45: About Integration Of Emr Systems

    You can also send test results to your EMR system manually even if these test results have not been ordered from your EMR system. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 45/144...
  • Page 46: About Using Easyone Air To Process Orders

    About using EasyOne Air to process orders When you synchronize EasyOne Air with EasyOne Connect, orders from your EMR system are also synchronized with EasyOne Air. On EasyOne Air, you can select orders from your EMR system in the orders menu. 6.2.4 Overview of the integration process Please contact the ndd Servicing Department to start an integration project.
  • Page 47: Overview Of The Plug-Ins For Emr Systems

    Initiating a spirometry test with the direct-start workflow, 49 Sending individual test results to your EMR system, 50 Type, 113 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 47/144...
  • Page 48: About The Xml File Exchange Plug-In

    You have configured the HL7 plug-in, the XML plug-in, or a custom  EMR plug-in.  Additional orders button in the main menu Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 48/144...
  • Page 49: Initiating A Spirometry Test With The Direct-Start Workflow

    5 In all other fields, enter additional patient data if necessary. 6 Choose OK. 7 Choose the desired test and confirm. 8 Perform spirometry with the patient. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 49/144...
  • Page 50: 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 V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 50/144...
  • Page 51: Performing Spirometry

    3 successful trials completed? End test Dispose of EasyOne Flow Tube Print report  General spirometry workflow using EasyOne Air stand-alone Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 51/144...
  • Page 52: About Preparation Of Spirometry And Instructions For The Patient

    Therefore, to perform the other spirometry tests, familiarize yourself with the other breathing maneuvers. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 52/144...
  • Page 53: About Quality Messages For Trials And Quality Grades For Tests

    Animation program for children If you use EasyOne Connect in combination with EasyOne Air, an animation program for children is available. The animation is available for the FVC test, the FVL test and the SVC test. You can choose between three animations: balloon, cake, and monkey.
  • Page 54: About Posts And Bronchodilation

     The summary screen is displayed.  About the summary screen, 56 Performing a complete test using EasyOne Air stand-alone, 57 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 54/144...
  • Page 55: Choosing A Test And Selecting An Existing Patient

    Choosing a test and selecting an existing patient If you test a patient that you have tested before or if you have transferred patient data onto EasyOne Air from EasyOne Connect on your PC, start by selecting an existing patient.
  • Page 56: About The Summary Screen

    In addition, you can access reports of previous tests of the patient.  Performing a complete test using EasyOne Air stand-alone, 57 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 56/144...
  • Page 57: Performing A Complete Test Using Easyone Air Stand-Alone

    The EasyOne Flow Tube is a single-patient-use disposable and hygienically packaged. Visually check the wrapper of a new EasyOne Flow Tube for defects. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 57/144...
  • Page 58 Visually check the EasyOne Flow Tube for defects before use and between trials. Before you use EasyOne Air with the patient, make sure that there are no obvious or wet residues on EasyOne Air from prior cleaning.  To prepare the test 1 Partly unwrap the EasyOne Flow Tube.
  • Page 59  When you insert the EasyOne Flow Tube, avoid direct sunlight as it can interfere with the automatic recognition of the EasyOne Flow Tube. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 59/144...
  • Page 60  The patient must not block the opening with the tongue or teeth or bite down excessively on the EasyOne Flow Tube. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 60/144...
  • Page 61  After three acceptable trials, the test ends automatically and a green acceptability message is displayed. 4 Choose Data.  The report screen is displayed. 5 Choose session. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 61/144...
  • Page 62 EasyOne Flow Tube holder or the inside of EasyOne Air while cleaning. To clean EasyOne Air, do not fully dip EasyOne Air into any fluid. To clean EasyOne Air and to disinfect your hands after each patient, do the...
  • Page 63: Performing Spirometry Using Easyone Connect In Combination With

    Bluetooth built-in. List of box contents, 17 If EasyOne Air is directly connected to a PC over USB, performing tests is not possible. Leakage currents could harm the patient. Connect EasyOne Air to your PC wirelessly, only.
  • Page 64: Performing A Complete Test Using Easyone Connect Together With

    Performing spirometry 7.6.2 Performing a complete test using EasyOne Connect together with EasyOne Air Required materials A new EasyOne Flow Tube for each patient  For an FVL test, an MVV test, or an SVC test, a nose clip is required.
  • Page 65 Visually check the EasyOne Flow Tube for defects before use and between trials. Before you use EasyOne Air with the patient, make sure that there are no obvious or wet residues on EasyOne Air from prior cleaning.  To prepare the test 1 Partly unwrap the EasyOne Flow Tube.
  • Page 66 EasyOne Flow Tube. Proceed with step 9. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 66/144...
  • Page 67 To perform the FVC breathing maneuver with the breathing maneuver for the required test. Breathing maneuvers for all available tests, 75 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 67/144...
  • Page 68 Decide whether the test quality is sufficient or not. c) If necessary, add a trial and repeat the previous procedure To perform the FVC breathing maneuver. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 68/144...
  • Page 69 EasyOne Flow Tube holder or the inside of EasyOne Air while cleaning. To clean EasyOne Air, do not fully dip EasyOne Air into any fluid. To clean EasyOne Air and to disinfect your hands after each patient, do the...
  • Page 70  List of cleaning solutions for EasyOne Air, 81 About interpreting results, 72 Description of printer configurations of EasyOne Connect, 116 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 70/144...
  • Page 71: Performing A Bronchial Provocation Test Using Easyone Connect In Combination With Easyone Air

    Watch the patient for signs of dizziness and support the patient if necessary. Do not leave the patient unattended during a test. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 71/144...
  • Page 72: About Interpreting Results

    On the printed report, parameters that are below the lower limit of normal (LLN) are marked with an asterisk (*). Unacceptable trials are marked with the number sign (#). In addition to the marks, EasyOne Air and EasyOne Connect offer an automatic interpretation aid.
  • Page 73: List Of Quality Messages And Quality Grades

    No acceptable trial available  Quality grades for the FVC test, the FVL test, and the OSHA test Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 73/144...
  • Page 74 At least 2 acceptable trials but the results are not reproducible according to 'B'. D (2) Only one acceptable trial No acceptable trial available  Quality grades for the SVC test Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 74/144...
  • Page 75: 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 spirometry, 51 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 75/144...
  • Page 76: 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 spirometry, 51 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 76/144...
  • Page 77: About The Osha Test

    From the test menu in EasyOne Connect, choose the OSHA test. On EasyOne Air, choose the OSHA test from the more menu. The patient performs the same breathing maneuver as for the FVC test. Reports meet the requirements of the following institutions and standards: •...
  • Page 78: Performing The Breathing Maneuver For The Mvv Test

    5 Tell the patient to take the EasyOne Flow Tube out of the mouth and to breathe normally again.  Performing spirometry, 51 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 78/144...
  • Page 79: 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 spirometry, 51 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 79/144...
  • Page 80: Hygiene And Cleaning

    EasyOne Flow Tube with the wrapper again and dispose of the EasyOne Flow Tube together with the wrapper. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 80/144...
  • Page 81: List Of Cleaning Solutions For Easyone Air

    To clean EasyOne Air, do not immerse EasyOne Air in any fluid. To clean EasyOne Air from environmental dirt, you can use a damp cloth. After each patient, clean EasyOne Air. You can use a soft cloth with a cleaning solution according to the following list.
  • Page 82: Working With Patient Data And Reports

    In each step, enter the requested data and choose Next >. 4 In the last step, choose Finish.  The summary screen is displayed. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 82/144...
  • Page 83: Editing Patient Data On Easyone Air

    3 Select a patient and confirm the message that is displayed.  The selected patient data is deleted. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 83/144...
  • Page 84: Exporting Data From Easyone Air

    2 Insert the SD memory card into the SD card slot. 3 Close and lock the battery compartment by turning the lock screw counterclockwise. 4 Choose > Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 84/144...
  • Page 85: Viewing And Printing Reports On Easyone Air

    To view the reports sorted by patient, choose >  Viewing and printing reports on EasyOne Air, 85 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 85/144...
  • Page 86: Working With Patient Data And Reports In Easyone Connect

     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 V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 86/144...
  • Page 87: Merging Two Patient Data Records With Easyone Connect

     The patient and all corresponding tests are deleted from the database.  About user handling and the default password of EasyOne Connect, 105 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 87/144...
  • Page 88: Copying Patient Data Between Easyone Air And Easyone Connect

    EasyOne Connect to your EMR system. EASYONE AIR MAY FREEZE If EasyOne Air is connected to your PC via USB and if there are also electromag- netic fields from other electrical devices nearby, EasyOne Air may freeze.
  • Page 89: Viewing And Printing Reports With Easyone Connect

     EasyOne Connect displays a message whether the sending has been successful.  You can remove EasyOne Air from the cradle, or you can repeat steps 2 to 7 to create and send additional patient records.  Viewing and printing reports with EasyOne Connect, 89...
  • Page 90: About The Trend View With Easyone Connect

    1 is rank 1. The second last trial that you set to rank 1 is rank 2, and so forth. 5 To close the overlay window, choose ×. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 90/144...
  • Page 91: About Exporting Comprehensive Data From Easyone Connect

     Description of report configurations of EasyOne Connect, 115 Software Developer Guide SDK – ndd EMR plug-in Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 91/144...
  • Page 92: About Exporting From Easyone Connect To Easyware

    Microsoft Active Directory user account that the current Windows user is logged in with.  EasyWare Operator’s Manual Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 92/144...
  • Page 93: Configuration

    Configurations in the settings menu of EasyOne Air > 11.1.1.1 Description of device settings of EasyOne Air > > On this screen, you can choose basic settings for EasyOne Air. Setting Purpose Options Default setting Speaker volume To set the speaker volume 0% –...
  • Page 94: Description Of Spirometry Settings Of Easyone Air

    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 95  NLHEP interpretation algorithm The diagram above shows how the interpretation for NLHEP is determined, according to Ferguson (2000/NLHEP) [4]. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 95/144...
  • Page 96 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 V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 96/144...
  • Page 97 The diagram above shows how the interpretation for NICE is determined. The NICE interpretation is mainly used in the UK. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 97/144...
  • Page 98 The peak expiratory flow can be specified in liters per minute (L/min) or in liters per second (L/s). Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 98/144...
  • Page 99: Description Of Display Settings Of Easyone Air

     Description of display settings Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 99/144...
  • Page 100: Description Of Print Settings Of Easyone Air

    Configuration 11.1.1.4 Description of print settings of EasyOne Air > > You can determine basic settings for printouts when using EasyOne Air and the cradle. There are more comprehensive configuration options available for printouts when using EasyOne Connect. Setting Purpose...
  • Page 101: Performing A Firmware Update With Easyone Air

    In this menu, you can update the firmware of EasyOne Air. CAUTION FAILED UPDATE An update may fail unnoticed. After performing an update, restart EasyOne Air and EasyOne Connect and per- form a calibration check. Calibration check, 118 Checking for correct operation of EasyOne Air, 122...
  • Page 102: Performing A Backup Of Easyone Air

    To archive a copy of the complete database (including patient data and results) and of the configuration settings, perform backups regularly. You can also use the backup to set up another EasyOne Air with the same database and configuration settings.
  • Page 103: About The Information Menu Of Easyone Air

    About the information menu of EasyOne Air > The information menu displays the firmware version of EasyOne Air. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 103/144...
  • Page 104: About The User Menu Of Easyone Air

    To discard any changes to the configuration, choose the Cancel button. The previous configuration stays in effect. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 104/144...
  • Page 105: About User Handling And The Default Password Of Easyone Connect

    260x80 pixels or smaller. To select or change the graphic file, choose Browse. To remove the graphic file, choose Remove. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 105/144...
  • Page 106: Utilities > Configuration > General > Storage

    The default configurations in this tab are determined by your language settings and by your regional settings in Microsoft Windows. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 106/144...
  • Page 107: Activating User Handling And Administering User Accounts

    Other parameters are taken from the best trial (also defined by the largest sum of FEV and FVC). Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 107/144...
  • Page 108: 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 109  NLHEP interpretation algorithm The diagram above shows how the interpretation for NLHEP is determined, according to Ferguson (2000/NLHEP) [4]. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 109/144...
  • Page 110 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 V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 110/144...
  • Page 111 The diagram above shows how the interpretation for NICE is determined. The NICE interpretation is mainly used in the UK. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 111/144...
  • Page 112: 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 V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 112/144...
  • Page 113: Utilities > Configuration > Test > Fvc / Fvl

    Show predicted points Show predicted range. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 113/144...
  • Page 114: Utilities > Configuration > Test > Svc

    Reported Graph You can select which type of curve you prefer for the calibration check report. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 114/144...
  • Page 115: Utilities > Configuration > Test > Provocation

    The layout editor allows for customization of the reports’ layout. For details, contact your EasyOne dealer or the ndd Servicing Department. Contact information, 4 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 115/144...
  • Page 116: Loading And Selecting A Custom Report Layout Of Easyone Connect

    Loading and selecting a custom report layout of EasyOne Connect You can load custom report layouts according to your requirements. For easy identification you can rename the report layouts. Your EasyOne Air dealer or the ndd Servicing Department can assist you in creating a custom report layout.
  • Page 117: Description Of Environment Configurations Of Easyone Connect

    • MVV test • SVC test • Provocation test (if the FVL test is configured for the provocation test) Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 117/144...
  • Page 118: Calibration Check

    Calibration of EasyOne Air is not possible. You can merely check EasyOne Air for correct calibration. Do not attempt to repair EasyOne Air yourself. A third-party service must not at- tempt to repair EasyOne Air either. Do not open or remove the casing.
  • Page 119 The printout shows at least nine trials, three for each flow level.  List of tests and parameters, 36 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 119/144...
  • Page 120: Performing A Calibration Check With Easyone Air

     An EasyOne Flow Tube  The ultrasonic sensor of EasyOne Air does not require calibration. Only unforeseeable reasons can lead to a malfunction that affects results. In these cases, you can determine whether EasyOne Air operates normally with a simple calibration check.
  • Page 121  If all maneuvers were acceptable, the calibration check is completed.  List of troubleshooting solutions, 122 Contact information, 4 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 121/144...
  • Page 122: 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 Air is operating correctly. b) If the results of steps 1 and 2 are not plausible, troubleshoot.
  • Page 123  Troubleshooting solutions  List of quality messages and quality grades, 73 Contact information, 4 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 123/144...
  • Page 124: About Reactivating Easyone Air After Storage

    Contact your EasyOne dealer or the ndd Servicing Department. To reactivate EasyOne Air, you must setup EasyOne Air like you did for the first-time setup.  List of specifications for EasyOne Air, 125...
  • Page 125: Specifications And Bibliography

    100 to 240 V AC, 50 to 60 Hz voltage Appliance class Class II  Specifications for EasyOne Air Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 125/144...
  • Page 126 Instrument not suitable for use in areas with flammable anesthetic gases and in areas with mixtures containing O or NO Wireless connection This specification is not applicable to the EasyOne Air TL variant. Type Bluetooth: v2.1 + EDR, v3.0 + HS, WiFi : IEEE 802.11a/b/g/j, v4.0...
  • Page 127 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 and...
  • Page 128: List Of Specifications For The Lithium-Ion Battery Of Easyone Air

    Do not use the battery in combination with any other batteries. Keep out of the reach of children. Only charge the battery when inside of EasyOne Air and in conjunction with the cradle and the power supply provided by the manufacturer.
  • Page 129 Discharge cut off- voltage 2.8 V to 3.0 V Initial impedance ≤200 mΩ The following standard conditions are identical to the conditions of EasyOne Air. Storage and operation under these conditions is safe. Standard storage conditions Temperature -20°C to 50°C (-4°F to 122°F)
  • Page 130 Standards Technical Services Co., Ltd., Shanghai in project number 710351.  Specifications for the lithium-ion battery of EasyOne Air Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 130/144...
  • Page 131: List Of Order Numbers And Accessories For Easyone Air

    Power supply for EasyOne Air with India 2500-50.5MJKM adapter type M adapter for India (replacement)  Order numbers and accessories for EasyOne Air Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 131/144...
  • Page 132: List Of System Requirements For Easyone Connect

    [13] Miller et al. ATS/ERS Task Force: Standardization of Lung Function Testing. Numbers 1 to 5, European Respiratory Journal, Vol 26, 2005, pp 153-161, 319-338, 511-522, 720-735, 948-968. Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 132/144...
  • Page 133 Occupational Health Programs: Best Practices for Healthcare Professionals. OSHA 3637-03, 2013.  Application Note Reference Predicted Normal Values Application Notes for further information, 3 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 133/144...
  • Page 134 ....114 selecting curve type for report ....114 Single Flow calibration check ....114 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 134/144...
  • Page 135 ........ 132 GOLD/Hardie interpretation algorithm ..95 trend view ..........90 working with patient data ......82 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 135/144...
  • Page 136 OSHA (Occupational Safety and Health Administration) ..........77 OSHA tests ............. 77 quality grades ..........73 see also, tests Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 136/144...
  • Page 137 ......11 definition ........... 35 Scope of delivery ..........17 Predicted normal values ........39 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 137/144...
  • Page 138 ....79 quality grades ..........74 quality messages ........73 see also, tests Syringe volume, setting ......... 114 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 138/144...
  • Page 139 ....122 overview ..........122 possible problems ........122 solutions ..........122 Updating EasyOne Connect ........25 Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 139/144...
  • Page 140: Electromagnetic Compatibility (Emc)

    IEC 60601-1-2:2014 4 edition (according clause 7 and 8.9, tables 4 to 9). EasyOne Air is a medical device that requires special safety precautions and must be installed and placed in operation in accordance with the information given in tables below.
  • Page 141: Wireless Module

    Electromagnetic emission Guidance and manufacturer’s declaration – electromagnetic emissions EasyOne Air is intended for use in the electromagnetic environment specified below. The user of EasyOne Air should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance...
  • Page 142: Electromagnetic Immunity

    IEC 60601-1-2. Guidance and manufacturer’s declaration – electromagnetic Immunity EasyOne Air is intended for use in the electromagnetic environment specified below. The user of EasyOne Air should assure that it is used in such an environment. Immunity test standard...
  • Page 143 If the measured field strength in the location in which the EasyOne Air is used exceeds the applicable RF compliance level above, the EasyOne Air 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 Air.
  • Page 144  Recommended separation distances between portable and mobile RF communications equipment and EasyOne Air Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch...

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