NDD EasyOne Air Operator's Manual
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NDD EasyOne Air Operator's Manual

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new diagnostic design
EasyOne Air
Operator's Manual V03
9000007/03
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

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  • Page 1 EasyOne Air Operator’s Manual V03 9000007/03 © 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 V03 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 V1.13.0. 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 Use Of The Easyone Air Spirometer

    1.4. Intended use of the EasyOne Air spirometer The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinics, in pharmacies, and in clinical settings in occupational medicine.

  • Page 4: Legal Information

    Tel: +1 978 470 0923 Fax: +41 (0) 44 512 65 01 Fax: +1 978 470 0924 www.ndd.ch www.nddmed.com Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 4/105...

  • Page 5: Product Registration

    Please make use of your local WEEE collection facilities to dispose of this product and otherwise observe all applicable requirements. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 5/105...

  • Page 6: Table Of Contents

    3.3. Setting up the physical components ......20 3.4. Setting up the EasyOne Air spirometer......23 3.5.
  • Page 7 4.1. Introduction to the EasyOne Air spirometer ..... 25 4.1.1. Overview of EasyOne Air ......25 4.1.2.
  • Page 8 10. Configuration 10.1. Configuration of EasyOne Air ....... . 72 10.1.1.
  • Page 9 13. Specifications and bibliography 13.1. List of specifications for EasyOne Air ......89 13.2. List of specifications for the lithium-ion battery of EasyOne Air ..91 13.3.

  • Page 10: 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 11 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 12 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 13: Safety Information Regarding Electromagnetic Compatibility

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

  • Page 14: About Requirements For Connections To External Devices

    2.4. 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 15: List Of Equipment Icons

    Instrument classification: Type BF applied part Class II equipment For indoor use only Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 15/105...
  • Page 16 Atmospheric pressure limitation Serial number Batch code Catalog number Medical Device Authorized representative in the European Community Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 16/105...

  • Page 17: List Of Box Contents

    The box contains the following items: EasyOne FlowTube respiratory tubes EasyOne Air spirometer  Box contents – top inlay Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 17/105...
  • Page 18 USB flash drive 2x USB cable Nose clip ndd power supply Cradle  Box contents – bottom inlay Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 18/105...

  • Page 19: About Compatible Printers

    EasyOne Connect can use any printer that is installed on your PC. To print using EasyOne Connect, connect the printer to your PC and not to the cradle.  Description of print settings of EasyOne Air  7 8 Setting up the physical components  2 0 Application Note Printer Compatibility List Application Notes for further information ...

  • Page 20: Setting Up The Physical Components

    1 Unlock and open the battery compartment by turning the lock screw clockwise. 2 Insert the battery into the battery compartment of EasyOne Air. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch...
  • Page 21  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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 21/105...
  • Page 22 Plug the ndd power supply into a power outlet, which is easily accessible for connection and disconnection. b) Connect the cable of the ndd power supply to the right USB port of the cradle (marked with the plug icon).

  • Page 23: Setting Up The Easyone Air Spirometer

     Configuration of EasyOne Air  7 2 Description of print settings of EasyOne Air  7 8 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 23/105...

  • Page 24: Installing Or Updating The Easyone Connect Software On Your Pc

     CAUTION FAILED UPDATE An update may fail unnoticed. After performing an update, restart EasyOne Air and EasyOne Connect and per- form a calibration check. Cybersecurity  3 7 Checking for correct operation of EasyOne Air  8 6 1 Connect the USB flash drive from the box contents to your PC.

  • Page 25: Introduction

    USB port to connect to the cradle Lock screw for battery compartment Battery compartment  Bottom-view of EasyOne Air Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 25/105...
  • Page 26 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 manually switch off the device by pressing the power button. The EasyOne FlowTube respiratory tube for single-patient use ...

  • Page 27: Overview Of The User Interface Of Easyone Air

    In the patients menu, you have access to patient data and also to the reports, which are sorted by patient here. In the tools menu, you can configure EasyOne Air and perform calibration checks and have access to settings and database functionalities.
  • Page 28 In the update menu, you can perform firmware updates. In the database menu, you can backup, restore and delete the patient database and configurations. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 28/105...
  • Page 29 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  7 2 Operator’s Manual V03 •...
  • Page 30 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 31: Overview Of Features Of 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 32: List Of Tests And Parameters

    FEF 25-75 Forced expiratory volume after 0.25 seconds Forced expiratory volume after 0.5 seconds  Parameters Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 32/105...
  • Page 33 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 33/105...
  • Page 34 Inspiratory vital capacity, from slow inspiration Highest VC value from all trials of one test Tidal volume  Parameters Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 34/105...

  • Page 35: List Of Abbreviations

    Universal Serial Bus (USB)—standard for data transfer, connecting devices, and battery charging, applies to cables and connectors  Abbreviations Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 35/105...

  • Page 36: About Sources For Predicted Normal Values

    Introduction 4.6. 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.  Application Note Reference Predicted Normal Values Application Notes for further information ...

  • Page 37: Cybersecurity

    • Passwords should be renewed after 90 days.  About user handling and the default password of EasyOne Connect  8 2 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 37/105...

  • Page 38: 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 ©...

  • Page 39: Dealing With A Lost Or Stolen Easyone Air Or Pc

    Cybersecurity 5.6. 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 40 Optionally, fill out the other fields. f) Choose OK.  User handling is activated. Now, users must log in to use EasyOne Air. 3 To prevent unauthorized access when EasyOne Air is unattended, specify a time period for automatic power-off: a) Choose >...

  • Page 41: Performing Spirometry

    3 successful trials completed? End test Dispose of EasyOne FlowTube Print report  General spirometry workflow using EasyOne Air stand-alone Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 41/105...

  • Page 42: 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 42/105...

  • Page 43: About Quality Messages For Trials And Quality Grades For Tests

    Performing spirometry 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 44: Performing Spirometry Using Easyone Air Stand-Alone

    >. 5 In the last step, choose Finish. 6 Optionally, enter additional information about the patient.  Performing a complete test using EasyOne Air stand-alone  4 6 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch...

  • Page 45: 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 46: Performing A Complete Test Using Easyone Air Stand-Alone

    The EasyOne FlowTube is a single-patient-use disposable and hygienically packaged. Visually check the wrapper of a new EasyOne FlowTube for defects. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 46/105...
  • Page 47 Visually check the EasyOne FlowTube 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 FlowTube.
  • Page 48  The sensor starts buzzing and the user action required window is displayed for setting the baseline. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 48/105...
  • Page 49 FVC breathing maneuver with the breathing maneuver for the required test. Breathing maneuvers for all available tests  5 8 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 49/105...
  • Page 50  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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 50/105...
  • Page 51 EasyOne FlowTube 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 52: Performing Spirometry Using Easyone Connect In Combination With

    Bluetooth built-in. List of box contents  1 7 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 53: 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 53/105...

  • Page 54: 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 struck through. In addition to the marks, EasyOne Air and EasyOne Connect offer an automatic interpretation aid.

  • Page 55: List Of Quality Messages And Quality Grades

    For a list of all quality messages, see the Application Note EasyWarePro Message Numbers on the ndd website.  Application Notes for further information  3 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 55/105...

  • Page 56: List Of Quality Grades For Tests

    , respectively. No acceptable trial available Result should not be used. About the SSA test  1 00 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 56/105...
  • Page 57 Result might have clinical utility. Interpret with caution. No acceptable trial available Result should not be used. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 57/105...

  • Page 58: 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  4 1 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 58/105...

  • Page 59: 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  4 1 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 59/105...

  • Page 60: Performing The Breathing Maneuver For The Mvv Test

    5 Tell the patient to take the EasyOne FlowTube out of the mouth and to breathe normally again.  Performing spirometry  4 1 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 60/105...

  • Page 61: 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  4 1 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 61/105...

  • Page 62: Hygiene And Cleaning

    4 After the patient has completed the breathing maneuver, grip the EasyOne FlowTube with the wrapper again and dispose of the EasyOne FlowTube together with the wrapper. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 62/105...

  • Page 63: 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 64: Working With Patient Data And Reports

    In each step, enter the requested data and choose Next >. 4 In the last step, choose Finish. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 64/105...

  • Page 65: 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 65/105...

  • Page 66: 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 66/105...

  • Page 67: Viewing And Printing Reports On Easyone Air

    5 If you want to print the report, do the following: a) Dock EasyOne Air to the cradle that is connected to a printer. b) Choose Print.  A progress bar is displayed, which indicates the progress of the print- out.

  • Page 68: Working With Patient Data And Reports In Easyone Connect

    In this case, you cannot merge these two data records. 4 To finish, confirm the message. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 68/105...

  • Page 69: Copying Patient Data Between Easyone Air And

    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 70: About The Trend View 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.  About connectivity and data exchange  3 6 9.2.3.

  • Page 71: Assessing Tests Retrospectively With Easyone Connect

    5 To close the overlay window, choose ×.  About user handling and the default password of EasyOne Connect  8 2 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 71/105...

  • Page 72: Configuration

    Configurations in the settings menu of EasyOne Air > 10.1.1.1. Description of system settings of EasyOne Air > > On this screen, you can choose basic settings for EasyOne Air. Setting Purpose Speaker volume To set the speaker volume Key click...

  • Page 73: 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 List of bibliographic references ...
  • Page 74  NLHEP interpretation algorithm The diagram above shows how the interpretation for NLHEP is determined, according to Ferguson (2000/NLHEP) [4]. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 74/105...
  • Page 75 (2002) [12]. The smoker status is not part of the GOLD/Hardie standard of 2008, only of 2003. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 75/105...
  • Page 76 The diagram above shows how the interpretation for NICE is determined. The NICE interpretation is mainly used in the UK. Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 76/105...

  • Page 77: Description Of Security Settings Of Easyone Air

    Disable PDF printing Disable the print to PDF function  Description of security settings  Cybersecurity  3 7 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 77/105...

  • Page 78: Description Of Print Settings Of Easyone Air

    Configuration 10.1.1.4. 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 79: 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 80: 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 V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 80/105...

  • Page 81: About The User Menu Of Easyone Air

    Security policies, like password strength and password expiration, must be handled by the operating institution, for example the hospital or practice. EasyOne Air provides the option to enforce strong password rules. See Description of security settings of EasyOne Air  7 If user accounts are password-protected, users are only prompted for their password once for login.

  • Page 82: Configuration Of Easyone Connect

    EMR configuration.  About connectivity and data exchange  3 6 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 82/105...

  • Page 83: Activating User Handling And Administering User Accounts

    8 To discard the changes, choose Cancel.  About user handling and the default password of EasyOne Connect  8 2 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 83/105...

  • Page 84: 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 85  If all maneuvers were acceptable, the calibration check is completed.  List of troubleshooting solutions  8 6 Contact information  4 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 85/105...

  • Page 86: 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 87  Troubleshooting solutions  List of quality messages and quality grades  5 5 Contact information  4 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 87/105...

  • Page 88: About Reactivating Easyone Air After Storage

    Contact your EasyOne distribution partner 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  8 9 About charging the battery of EasyOne Air ...

  • Page 89: Specifications And Bibliography

    Nominal input 160 mA to 80 mA current Appliance class Class II  Specifications for EasyOne Air Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 89/105...
  • Page 90 Specifications and bibliography Instrument Type BF applied part (the surface of the EasyOne Air enclosure) classification Powered internally with a lithium-ion battery Short usage time, less than 10 minutes Not intended to be used in the presence of oxygen-rich environments...

  • Page 91: 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 92 Specifications and bibliography The following standard conditions are identical to the conditions of EasyOne Air. Storage, transport, and operation under these conditions is safe. Standard storage and transport Temperature -20°C to 50°C (-4°F to 122°F) conditions Relative humidity 5% to 90%...

  • Page 93: List Of Order Numbers And Accessories For Easyone Air

    Hard disk capacity 1 GB (software) 4 GB (database) 2 GB  System requirements for EasyOne Connect Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 93/105...

  • Page 94: List Of Bibliographic References

    Professionals. OSHA 3637–03, 2013.  Application Note Reference Predicted Normal Values Application Notes for further information  3 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 94/105...

  • Page 95: Index

    ..14 Dirt, see cleaning Disinfecting, see cleaning Calibration result messages ......... 55 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 95/105...
  • Page 96 Infection, avoiding .......... 62 Installing EasyOne Connect ........24 Instrument, see system Intended use ............ 3 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 96/105...
  • Page 97 Quality messages ..........55 see also, tests Quality, assessing quality of test ...... 73 Standardization, spirometry ......94 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 97/105...
  • Page 98 Theft of EasyOne Air ........39 Tools menu on EasyOne Air ......27 Trend view ............70 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 98/105...

  • Page 99: Appendix

    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 100: About The Ssa Test

    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 101: Compliant Cables And Accessories

    EasyOne Air contains a wireless module for Bluetooth communication. See Wireless connection in:  List of specifications for EasyOne Air  8 9 Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch 101/105...

  • Page 102: Electromagnetic Emission

    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 103: 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 104 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 105  Recommended separation distances between portable and mobile RF communications equipment and EasyOne Air Operator’s Manual V03 • EasyOne Air • EasyOne Connect 9000007/03 ©...

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