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Medical Technologies EasyOne Pro Operator's Manual

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EasyOne Pro™
EasyOne Pro™ LAB
Operator's Manual
Version V03C

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Summary of Contents for Medical Technologies EasyOne Pro

  • Page 1 EasyOne Pro™ EasyOne Pro™ LAB Operator's Manual Version V03C...
  • Page 2 EasyOne Pro™, barriette™ and spirette™ are trademarks owned by ndd Medizintechnik AG. This manual describes the product EasyOne Pro™ and its variant EasyOne Pro™ LAB. The safety information and all operating instructions apply to both devices. Safety information and operating instructions that apply only to EasyOne Pro™...

  • Page 3: Table Of Contents

    Contraindications to Performing DLCO Tests Additional Functions of EasyOne Pro™ LAB 1.10 Components and Functional Description of EasyOne Pro™ 1.11 EasyOne Pro™ Flow Sensor Design and Operation 1.12 Test Gas Requirements Start-up and Initial Preparation Unpacking, Environmental Conditions Equipment Description...
  • Page 4 12.6 Report Designer 12.7 Electromagnetic Compatibility (EMC) 12.8 Microsoft Software License Terms for Windows® XP Embedded Runtime 12.9 Quick Reference Guide to the Screen Displays 12.10 EasyOne Pro LAB Washout Moment Analysis 12.11 Literature EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 5: Introduction

    Introduction Introduction 1.1 CE Marking Information The product EasyOne Pro™ bears the CE marking CE-120 (notified body  SGS) indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive.

  • Page 6: Revision History

    Please note that information pertinent to several chapters is given only once. Therefore, read the manual once in its entirety. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 7 The illustrations in this manual are only examples. They are not binding  in any way. No part of this manual may be reproduced without written permission  from ndd. © 2012 ndd Medizintechnik AG, Technoparkstr. 1, CH-8005 Zürich, Switzerland EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 8 Safety Notices Danger Explosion Hazard—EasyOne Pro™ is not designed for use in areas of medical locations where an explosion hazard may exist. Explosion hazards may result from the use of flammable anesthetics, skin cleansing agents or disinfectants.
  • Page 9 Check the cables and connectors, in particular, for signs of damage. Replace damaged cables and connectors immediately, before use. Do not expose EasyOne Pro™ to direct sunlight to  prevent system components from reaching inadmissible, high temperatures. Furthermore, EasyOne Pro™ has no additional protection against the ingress of humidity.
  • Page 10 Risk of Infection—Proper use of the spirette™ and the DLCO barriette™/FRC barriette™ provides a reliable infection barrier. The use of other accessories is not permitted. Cross Contamination Between Patients—The spirette™ and the DLCO barriette™/FRC barriette™ are intended for EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 11 Always check the USB flash drive for viruses, before connecting it to the equipment. Equipment Damage—Do not set up EasyOne Pro™ in the direct vicinity of a window. Rain, humidity and sunlight may damage EasyOne Pro™. Do not operate EasyOne Pro™ in the vicinity of heating appliances (radiators).
  • Page 12 The valve of the pressurized gas cylinder may be opened only if the connected fittings are closed. Open the valve of the compressed gas cylinder very slowly. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 13: Equipment Symbols

    Potential equalization pin. Alternating voltage. Gas inlet for DLCO gas. Gas inlet for O2 (oxygen). The number found under this symbol is the date of manufacture in the YYYY-MM format. Manufacturer Type BF applied part EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 14: Intended Use

    The ndd EasyOne Pro™ Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro™ Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine.

  • Page 15: Components And Functional Description Of Easyone Pro

    Introduction 1.10 Components and Functional Description of EasyOne Pro™ Fig. 1-1 EasyOne Pro™, block diagram A Mains connector O Replaceable filter pack B Power supply unit P Gas supply tubing C Hard disk Q DLCO valve D Storage disk (backup)

  • Page 16: Easyone Pro™ Flow Sensor Design And Operation

    L. A molar mass sensor M based on ultrasound transit time measurement determines the helium content of the respired air. The oxygen supply unit V required by the EasyOne Pro™ LAB version is located on the left side of the device.

  • Page 17: Test Gas Requirements

    Use only the supplied original tubing to connect the gas cylinder to the device. Use only the original gas supply tube to connect the valve unit to the device. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 18 ), EasyOne Pro™ LAB only Medical grade oxygen; 100 % O . From compressed gas cylinders or the hospital's oxygen supply system. Note When using the wall outlet, please observe the hospital's in- house instructions and requirements. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 19: Start-Up And Initial Preparation

     Cleaning Before Initial Use EasyOne Pro™ does not require cleaning before its first use. The gas supply tube and the valve unit are cleaned before shipping, but not disinfected. These parts can be thoroughly cleaned as described in chapter "Hygiene, Cleaning, Maintenance, Disposal"...

  • Page 20: Equipment Description

    2.2 Equipment Description Fig. 2-1 EasyOne Pro™ a Sensor holder, extendible d ON/OFF switch b Sensor cable connection e Touch stylus c Connection for gas supply tube to f Sensor (see Fig. 2-3) sensor EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 21 Monitor replaced) k Serial RS232 ports p Nameplate l Connection for temperature and q Mains connector, mains power switch humidity sensor r Connection for O gas supply system (EasyOne Pro™ LAB only) EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 22: Preparing The Device

    DLCO barriette™ or for LAB FRC t Overpressure valves barriette™ u One-way valve w Motor block, release button x spirette™ Preparing the Device Connect the sensor cable to the device.  Fig. 2-4 Connecting the sensor cable EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 23 Connect gas supply tube to valve unit Connect the other end of the gas supply tube to the device and tighten  the coupling ring. Fig. 2-6 Connecting the gas supply tube to the device EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 24 Using the clamp, screw the sensor stand to the table top.  Open the catch and insert the sensor.  Close the catch.  Fig. 2-8 Inserting the sensor in its stand EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 25: Gas Supply

    Equipment not intended for mobile use can also be used with large gas cylinders. Use only the supplied original tubing to connect the gas cylinder to the device. Use only the original gas supply tube to connect the valve unit to the device. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 26 Port for EasyOne Pro™ connection tube c Pressure relief valve, secondary side (DLCO gas) Connect the tube to the DLCO gas port on EasyOne Pro™: push the tube  onto the stud, exerting sufficient force to overcome the initial resistance;...
  • Page 27 Exchange the gas cylinder if the primary pressure drops below 10 bar! Warning Be sure not to confuse the DLCO gas inlet and the FRC gas inlet. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 28 Start-up and Initial Preparation FRC Gas (100% O2), EasyOne Pro™ LAB only Medical grade oxygen is used for FRC measurements with EasyOne Pro™ LAB. Secondary pressure: 3 bar Flow: > 0.7 l/s (at 3 bar) Warning Improper handling of gas cylinders represents a major risk to persons and the environment.
  • Page 29 Start-up and Initial Preparation Connect the tube to the FRC gas inlet at the EasyOne Pro™ LAB (Fig.  2-13): push the tube onto the stud, exerting sufficient force to overcome the initial resistance; then advance the tube until the stop.

  • Page 30: Connecting The Keyboard And The Mouse

    Start-up and Initial Preparation 2.5 Connecting the Keyboard and the Mouse EasyOne Pro™ is equipped with a touch screen display and can thus be operated without a keyboard or a mouse. However, if you prefer working with a keyboard and a mouse, connect them to a USB port (g, Fig. 2-2).
  • Page 31 Select the test to print.  Fig. 2-15 Test selection Press Print: the printer window will appear.  Fig. 2-16 Printer window Select Search for Network printers.. Fig. 2-17 Printer window Select the printer to use.  EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 32: Power

    Note EasyOne Pro™ meets the safety requirements of UL, NFPA, LACTL, CSA, TUV, BSI, and IEC-60601 for leakage currents. The device is checked for leakage current before shipment. The ndd service representative (or distributor representative) will assist hospital personnel in verification, if requested.

  • Page 33: Inserting The One-Way Valve, Dlco Barriette™/Frc Barriette™ And Spirette

    DLCO barriette™. Warning Cross Contamination Between Patients—The DLCO barriette™ is intended for single patient use. Use a new one for each patient to prevent cross contamination between patients. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 34 Fig. 2-19 Attaching the one-way valve Insert the DLCO barriette™ in the one-way valve (aligning the arrows) as  shown in Fig. 2-20 and check that it sits tight. Fig. 2-20 Inserting the DLCO barriette™ EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 35 FRC barriette™ (EasyOne Pro™ LAB only) Note The FRC barriette™ is required only when also FRC tests will be performed with the EasyOne Pro™ LAB. If the EasyOne Pro™ LAB is used for DLCO testing, the DLCO barriette™ will also have to be attached here.
  • Page 36 When doing this, please ensure that the arrow on the spirette™ is lined up with the arrow on the flow sensor. You remove the spirette™ by pushing it out of the sensor from below.  Fig. 2-22 Inserting the spirette™ EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 37: Switching The Device On, Functional Test

    Check the secondary pressure: for DLCO gas , it must be 4 to 5 bar, and  for FRC gas, it must be 3 bar (EasyOne Pro™ LAB only). Turn on the mains power switch on the rear panel of the device.
  • Page 38 Click to quit the program e Click to review the results from Note EasyOne Pro™ is equipped with a touch screen display. You activate a button by touching it on the display. (h, Fig. 2-24) is used to display and remove the touch keypad that allows you to make all entries.
  • Page 39 Start-up and Initial Preparation Select Utilities -> Configuration -> Test -> DLCO.  Compare the displayed values with the data on the gas cylinder.  Close the tab with OK.  Fig. 2-25 DLCO tab EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 40: Performing A Test

    Click to view the selected patient's test criteria results j Additional parameters f Click to edit the selected patient's data k Back to main menu g Click to delete the data of the selected EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 41 At the same time, the patient's name appears at a. Note Click to view the patient data. Click again to close the window. Fig. 3-2 Window showing patient data EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 42 History (see Fig. 3-4), History and Comment tabs c. Close the window with OK.  The patient list will be displayed and the new patient is selected. a b c Fig. 3-3 Patient data window EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 43 Use Drag & Drop (right mouse button) to merge data records. Fig. 3-5 Merging a patient’s data records EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 44: Selecting A Test

    EasyOne when performing tests and the subsequent synchronization. Refer to the EasyOne tab (see "EasyOne Tab" on page 112) for configuration options. Fig. 3-7 Selection screen when the selected device is EasyOne EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 45: Forced Vital Capacity (Fvc/Fvl)

    The patient should be relaxed and should not wear tight clothing. The patient may stand or sit during the test. In exceptional cases, the patient may feel dizzy when performing the test. Therefore, watch your patients closely, if they are standing for the test. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 46  If you perform spirometry tests with EasyOne Pro™ on patients for the first time, you should practice testing yourself and others prior to testing patients. You will learn to recognize the cause of problems by interpreting the Quality Messages displayed by the program after each effort and how to avoid these problems.
  • Page 47 Enter key. During the test, you will see the flow-volume loop and the volume-time curve on the display. All curves and measured values will be displayed after the test. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 48 The test quality depends on the co- operation of the patient which, in turn, depends on the quality of the physician's instructions. EasyOne Pro™ incorporates an automatic quality control function. This function analyzes the test quality and displays a...
  • Page 49 Quality grade c Area for review comments b Click to perform a post-trial (see "Bronchodilation (Post-Tests)" page 52) Note If FEV6 is selected (instead of FVC), the measurement will stop automatically after 6 seconds. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 50 Click Perform Test.  Select the test, e.g. FVC.  A menu will appear. Fig. 3-13 Menu Click Add Trial or Add Post.  The acquisition screen will be displayed. Perform the new spirometry maneuvers.  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 51 Edit the values, if necessary, and click Confirm >> to close the window.  Warning Erroneous Measurement Results—Incorrect entries may lead to erroneous test readings and incorrect system interpretations. The specified measuring accuracy is ensured only when all entries are correct. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 52 After the test the Pre and Post results are compared. Post tests can only be added to previous tests performed on the same day. Select the patient.  Select the test, then click Add Post to close the window.  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 53 As soon as three acceptable trials have been performed, the message Session complete! appears and a quality grade from A (optimal) to F is displayed (see "Quality Messages and Quality Grades" on page 72). Fig. 3-16 Acquisition screen after three acceptable post-trials EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 54 (see "General Tab" page 100). Fig. 3-17 Balloon animation program for children, test start, successful test Fig. 3-18 Monkey animation program for children, test start The Monkey animation can be viewed in full-screen mode EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 55: Vital Capacity (Svc)

     when the start test prompt appears, take a maximum inspiration  followed by an immediate, but unhurried, exhalation. Select SVC.  The slow vital capacity acquisition screen appears. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 56 Click for a retrospective test evaluation or to expand the parameter list (see Conduct the tests as described in section "Measurement" on page 47.  EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 57: Maximum Voluntary Ventilation (Mvv)

     and as fast as possible over a period of 12 seconds. Select MVV.  The MVV acquisition screen appears. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 58 Click for a retrospective test evaluation or to expand the parameter list (see Conduct the tests as described in section "Measurement" on page 47.  Fig. 3-22 Acquisition screen after two acceptable MVV tests EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 59: Quick Test

    4 minutes. However, do not perform more than five consecutive DLCO tests on one patient (ATS/ERS Taskforce recommendations, literature [11] ("Literature" on page 165). Select the patient (see "Selecting/Adding a Patient" on page 40).  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 60 Fig. 3-24 shows the patient during a test, using the sensor stand (optional accessory). Fig. 3-24 Patient using the sensor (with optional stand) Press Start on the acquisition screen. EasyOne Pro™ will automatically  complete a start-up routine in about 15 seconds. Initialization ...
  • Page 61 After the 10 seconds, the valve opens and the patient is required to  exhale quickly, but avoiding forced breathing, and continue tidal breathing until the test stops. After a successful test, the message Good effort will be displayed. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 62 The collection bar identifies the range that was analyzed. With the + button f, you can expand the curve to check the collection bar range for artifacts (click - to reset the bar to its original width). EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 63 The text box h provides space for comments. A keypad will be displayed as soon as you touch the area. You can double-click on a point in the curve windows to hide a curve. The curve reappears when you double-click once more. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 64: Frc Test (Easyone Pro™ Lab Only)

    Performing a Test 3.8 FRC Test (EasyOne Pro™ LAB only) FRC measurement is based on the nitrogen (N ) washout method where N is washed out from the lungs while the patient breathes 100% oxygen. The test is performed during tidal breathing within the range indicated at a (Fig.
  • Page 65 After a successful test, the message Good effort will be displayed. Fig. 3-26 FRC Test a Tidal breathing e Tracer curve (logarithmic b Measuring curve representation, see "FRC (mbw) Tab" c Test results on page 110) d Enter comment EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 66: Ending The Test

    (see "Hygiene, Cleaning, Maintenance, Disposal" on page 89). 3.10 Retrieving/Printing Stored Tests EasyOne Pro™ saves all tests. Old measurements can be called up at any time to perform a new test with the same patient  add a spirometry trial ...
  • Page 67 Print to print the test, or Trend to view the trend display (see on page 69). Click Patients to display the patient list and "Trend View" click New Test to display the test selection menu. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 68 Click to print the displayed report test report d Click to access a submenu with options b Click to open the layout selection menu for zooming, exporting, viewing, printer selection and additional print functions EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 69: Trend View

    Fig. 3-30 Trend view of multiple parameters a Option buttons for selection of the view c Click to select a parameter b Displayed parameter labels d Icon to initiate the trend printout EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 70 Performing a Test Fig. 3-31 Trend view of a single parameter and its predicted normals EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 71: Editing Patient Data

    Click Update existing tests to close the window (for example, if the  entered patient data were incorrect and the tests need to be recalculated) or close the window with OK if you want to apply the edited data to future tests only. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 72: Quality Messages And Quality Grades

    The end-of-test criterion for an FVC test is as follows: A test ends when the volume change during the last 2 seconds is <45 ml, or an inspiratory volume >150 ml is detected. When this end-of-test criterion is met, the following quality messages are checked: EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 73 150 ml or 100 ml inhale even more deeply and  if FVC is < 1.0L (for age 6: 100 ml exhale even more air. or 10% of FEV1 or FVC* whichever is greater) EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 74 At least 2 acceptable trials but the results are not reproducible according to 'C'. Quality message: "Result not reproducible" OR only one acceptable trial. Quality message: "Only one acceptable trial". D (2) Only one acceptable trial No acceptable trial available EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 75: Svc Quality Messages And Quality Grades

     150 ml The test is complete. An adequate Session Complete! QC grade A, VC variability Great Job! and at least 3 acceptable trials number of good tests is available. available. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 76: Dlco Quality Messages And Quality Grades

    CO at zero not within 80 ppm CO at DLCO test gas not within 500 ppm Alveolar CO out of range Expiratory CO out of range VA out of range DLCO out of range EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 77 If the error occurs repeatedly then tidal breathing! breathing phase. please contact service. Breath-Num Breath number of DLCO expiration Perform the DLCO maneuver with could not be detected full effort Test cannot be evaluated; DLCO maneuver cannot be detected EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 78 ™ ™ CO-Insp Drift During breath-hold, CO signal Check spirette und barriette position, check connections, drifts up or down Maneuver not check DLCO valve unit acceptable; no sta- ble CO signal during breath-hold EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 79 Breath-hold time (BHT) of 8.0 to 12.0 seconds  Inspiratory time 4 seconds  Note The quality grades are recomputed if the user manually changes the sampling window position (repositioning of the collection bar). EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 80: Frc Quality Messages

    Automatic scaling of the CO sig- Contact service. CO2 sensor scaling nal failed. warning! FRC(MBW) Warning: No breath with an N concentra- Repeat test. Tracer concentration tion below 2% was measured. at test end too high! EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 81 (from the first breaths of the Check position of spirette™ and washout). of nose clip. Contact service. FRC(MBW) Error: Mount valve unit and repeat pro- DLCO Valve Unit NOT cedure. mounted on handle sensor! EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 82: System Interpretation

    The trial acceptability and ranking of tests can be changed retrospectively. This means that you can make tests unacceptable that the system judged acceptable and vice versa. You can also change the trial ranking (rank 1, 2 or Click a (Fig. 5-2).  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 83 In the ensuing window, select the Acceptable check box.  Fig. 5-3 Changing the trial ranking To assign the highest rank to a test click the icon and  in the ensuing window, click Set Highest Ranked (Fig. 5-4).  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 84 Enter a user ID, followed by the comment.  Close the window with Save.  The text will be shown in the comment window, including the user ID and the date. Fig. 5-5 Entering comments EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 85: Definition Of Important Parameters

    SVC, FVC, FVL or DLCO test VCex Expiratory Vital Capacity expiratory vital capacity of a slow spirometric test Inspiratory Vital Capacity inspiratory vital capacity of a slow spirometric test Inspiratory Capacity inspiratory capacity (VT + IRV) EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 86 (BTPS) DLCO/VA Krogh Factor Krogh factor Total Lung Capacity total lung capacity Note The parameter names used are those standardized by ATS and ERS. See literature references [14] and [11] ("Literature" on page 165). EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 87 (see "Literature" on page 165 [17] to [21]); for a detailed descrip- tion, please refer to chapter "Easy- One Pro LAB Washout Moment Analysis" on page 164 in the Appendix of this manual. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 88: Switching The Device Off

    Quit the program with  Fig. 6-1 Switch off EasyOne Pro™ with OK, or release gas pressure with Release  pressure, if you need to replace a gas cylinder. Then click OK to confirm the message. EasyOne Pro™ will automatically switch off.

  • Page 89: Hygiene, Cleaning, Maintenance, Disposal

    The one-way valve can be rubbed down with a cloth moistened with  alcohol (50% max.). Clean only the side facing the barriette™ and the housing. The one-way valve must be replaced each year. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 90 Particularly inspect the gas cylinder(s) and fittings. If you detect damage or impaired functions that may adversely affect the safety of the patient or user, do not use EasyOne Pro™ before it has been repaired. Once a year The following parts must be replaced once a year (see "Start-up and Initial...
  • Page 91 Follow these steps to exchange the memory card: Quit the program with and switch off EasyOne Pro™ with OK  (see "Switching the Device Off" on page 88).
  • Page 92 1. Data backup Save the patient data to a USB flash drive (memory stick).  2. Preparation Download the most recent revision of the EasyOne Pro software from  the ndd website: http://www.ndd.ch/Downloads/Software.aspx and copy the data to a USB flash drive (memory stick).
  • Page 93 (see "Calibration Check with Test Subject" page 96). The EasyOne Pro™ calibration can be checked with a syringe using the calibration check function. The American Thoracic Society (ATS) recommends that the spirometer calibration be checked on a regular basis.
  • Page 94 (see "Calibration Check with Test Subject" on page 96). In addition, the ATS/ERS guidelines (Literature [11], page 166) describe a third method for checking DLCO calibration for which a 3-L syringe is used. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 95 Simulator Test Gas are entered correctly as shown in Fig. 8-13. FRC Calibration Check The American Thoracic Society (ATS) recommends that testing of biological controls should be performed at least monthly. For that purpose use a biological subject and the standard trending functionality. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 96 Click to select a parameter c Deselect tests (remove check mark) g Click to display the graphic trends d Click to conduct a new test h Click to add a new BioCal Subject EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 97 This means also that by deselecting a baseline value, the first control value is moved to the baseline values, because a minimum number (20) of baseline tests is required for a valid analysis. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 98: Detailed Description

    The product described in this operator manual must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 99: System Settings

    Fig. 8-1 System settings menu Configuration These are the tabs of the configuration menu: General  Test  Device  Report  Printer   Environment  Fig. 8-2 Configuration menu, General tab EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 100  Fig. 8-3 Header tab a Fields for entry of the hospital/practice c Click to display information about the name software program b Click to display an illustration (logo) EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 101 Click to perform a data backup b Click to import a database f Click to select the database folder c Click to copy data from/to a storage medium d Path and name of the currently used database folder EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 102 Select option button for age or birth deselect date c Click to select the regional settings h Select the scroll bar width (date and time format) i Adjust the volume EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 103  enter an IP address c.  Fig. 8-6 Administrator tab a Click to map a network drive c Click to enter an IP address b Click to disconnect a network drive EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 104 The ID of the user who is logged on is shown next to the time. Fig. 8-7 User Handling tab a Select line to edit logged on users c Select check box to enable/disable the b Select to enter a new user function EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 105 Select this check box, if you want to stop tests manually Note The predicted normal is corrected by the factor i, if no specific calculation is defined for the ethnic group in the selected predicted normal publication. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 106 Predicted values are represented by b Select the test type points or as a range c Click to select a parameter e Select one of the options if you wish to print the lung age EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 107  Click e to scroll the list up and down. Note The parameter selection relates to the current test only. Different parameters can be selected for each test. Fig. 8-10 FVC parameters tab EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 108 You also select the parameters for the SVC measurement. Fig. 8-11 SVC tab MVV Tab On this screen, you select the parameters for the MVV measurement. Fig. 8-12 MVV tab EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 109 Select check box to automatically concentration must be within the range determine the discard volume indicated in parentheses. e Click to select a parameter (see Fig. 8-10) Warning Inaccurate Test Results—Incorrect gas concentration entries cause inaccurate test results. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 110 After the number of breaths specified d Click to select parameters (see Fig. at c the test either starts automatically 8-10) or the "Activate" button will be e Choose the tracer curve format displayed for manually starting the test EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 111 Click to switch the pump manually off e Click to select the sensor port from the dropdown list and on c Click to release pressure if the gas cylinder has to be exchanged EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 112 Test Configuration  General Configuration  Report Configuration  Consult the EasyOne operator manual for details. Fig. 8-16 EasyOne tab Selection Tab Select your preferred sensor type on this tab. Fig. 8-17 Selection tab EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 113 Press to open the printer list c Select the default printer b Press to update the printer list EMR Tab Here you select the EMR system and the corresponding settings (see "GDT Interface" on page 124). EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 114 Enter the GDT ID. d Press button to search for the GDT b Select the EMR system from the list. folder. c Select the character set from the list. e Click to install a new PCS system. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 115 (above sea level) data d Case temperature j Recalculate BTPS conversion factor e BTPS conversion factor (e.g. after a change of the ambient f ATPS values will be used, yes/no (no conditions) BTPS conversion) EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 116: Troubleshooting Tips

    Choose the correct volume differs from syringe volume via the actual syringe Configuration > Test > volume. Cal-Check. Note The most recent information and frequently asked questions can be found on our web site at www.ndd.ch. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 117: Specifications

    Sapaldia (Swiss), Roca (Spain, SEPAR), Vilozni 2005, Hedenström (Sweden), Gulsvik (Norway), Berglund, Birath (Sweden), Langhammer (Norway), Finnish, Nystad, Hibbert, Gore, Crockett, Ethiopia, Asia 1-4, JRS 2001, Fukuda Standard (see "Predicted Values" on page 123) EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 118 Operating 100 to 240 V, 50 to 60 Hz voltage range Power 80 VA consumption [max.] Life time 7 years EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 119: Order Information

    40 2050-5 spirette™ , pkg. of 200 3050-1 DLCO barriette™, pkg. of 50 3050-2 DLCO barriette™, pkg. of 100 3150-1 FRC barriette™, pkg. of 40 (for EasyOne Pro™ LAB only) 3000-60.1 Stand 3000-60.2 Carry bag Spare Parts 3000-50.1SP Filter pack 3000-50.2SP...

  • Page 120: Appendix

    The automatic system interpretation can be selected and deselected on the configuration tab (see "General Tab" on page 100). GOLD-Hardie Interpretation The following diagram outlines the criteria EasyOne Pro™ applies in the automatic interpretation after GOLD/HARDIE (see "Literature" on page 165 [12], [13]).
  • Page 121 Appendix NLHEP Interpretation The following diagram outlines the criteria EasyOne Pro™ applies in the automatic interpretation after NLHEP (see "Literature" on page 165 [4]). Note: 1. LLN = Lower limit of normal 2. If FEV6 is selected instead of FVC, FEV6 will be used for the interpreta- tion instead of FVC.
  • Page 122 Appendix NICE Interpretation Predominantly used in Great Britain. Source unknown. FER = FEV1/FVC EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 123: Predicted Values

    Normal Spirometry; at COPD risk No predicted values No interpretation, no predicted values 12.2 Predicted Values Note For the most recent predicted value sets and other pertinent information, please visit our website at http://www.ndd.ch. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 124: Gdt Interface

    12.3 GDT Interface Introduction The following describes the interface set up to facilitate the data communication between EasyOne Pro™ and an Electronic Medical Record System (EMR). As an example the integration of the German GDT standard is described. Software Settings...
  • Page 125  These adjustments are sufficient for the set up of the EMR software. Now proceed with the set up of EasyOne Pro™. Setup EasyOne Pro™ Software When the EMR interface is used for the first time, the following settings have to be made: Start EasyOne Pro™.
  • Page 126  Data accepted by EasyOne Pro™ from EMR / GDT The following data is read in by EasyOne Pro™ from the GDT interface. The data that is actually transmitted depends on the EMR (GDT) system used. Excessive data is ignored by EasyOne Pro™.
  • Page 127 0203107Schulstr. 1  01031101  0123622185  011362363  In addition to some GDT specific information the file contains the following patient information: Name, date of birth, gender, height in cm, weight in kg. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 128 Appendix View of tests with EasyOne Pro™ View test via GDT record type 6311 with patient name, ID and date and time of test As of EasyWare V2.8 GDT record type 6311 is supported. In the transmission of test results using GDT record type 6310, record type 8432...
  • Page 129 0378470System Interpretation Set: - 0096227 0128410FVC 0128411FVC 01384204.03 0108421L 0138410FEV1 0138411FEV1 01384203.67 0108421L 0178410FEV1/FVC 0178411FEV1/FVC 01384200.91 0098421 0188410FEF25-75% 0188411FEF25-75% 01384205.55 0128421L/s 0128410PEF 0128411PEF 014842010.60 0128421L/s 0128410FET 0128411FET 01384204.12 0108421s 0138410FIVC 0138411FIVC 01484203.67* 0108421L 0128410PIF 0128411PIF 01384209.38 0128421L/s EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 130: Introduction To Adjustment Of Dlco Measurements

    (according to other sources, the factor is 0.6206) Allowed range for Hb: 0 to 100 g/dl Default value male adults (age > 15): 14.6 g/dl (9.00 mmol/l) Default value female and children (age < 15): 13.4 g/dl (8.26 mmol/l EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 131 The following example can be used to test the DLCO adjustment feature. Factor Adjustment for Adjustment for women and children (< 15 J) Hemoglobin 32.4675 mmol/l 0.7023 0.69292 400 mbar CO-Hb 30 % 1.38889 1.38889 Total correction factor 1.6582 1.6361 EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 132: How To Interpret Tlc From A Single Breath Maneuver

    The value being above or below the lower limit of normal (LLN) determines the diagnostic path: For the case that TLCsb from the single breath maneuver is above LLN, it  is always correct to use the measured result in the ATS/ERS algorithm for EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 133 If the FEV1/FVC ratio is < 70%, the regression equation can be used to correct the TLCsb to a value more consistent with the TLCpleth or TLC- wash, reducing the possibility of an incorrect decision. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 134: Report Designer

    On the Report Designer tab, select New Report (Fig. 12-2: left).  Fig. 12-2: New Report button (left), test selection (right) Select the test to which you want to add the logo (Fig. 12-2: right).  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 135 Appendix Select the Picture Box (Fig. 12-3:).  Fig. 12-3: Picture Box button Insert the frame in the appropriate position (Fig. 12-4:).  Fig. 12-4: Positioning the frame EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 136 Select the test via New Report or Open.  Fig. 12-6: New Report, Open buttons Select Windows and then Report Explorer (Fig. 12-7:).  Select Detail Report Graph (Fig. 12-7:).  Click graphVT1.  EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 137 Choose options in the Trial Selection pane.  Choose options in the Appearance pane.  Fig. 12-9: Spiro Graph Configuration window Close the window with OK.  Save the test under a new name.  EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 138: Electromagnetic Compatibility (Emc)

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions EasyOne Pro™ is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that EasyOne Pro™ is used in such an environment. Emissions Test...
  • Page 139 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity EasyOne Pro™ is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that EasyOne Pro™ is used in such an environment. Immunity Test...
  • Page 140 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity EasyOne Pro™ is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that EasyOne Pro™ is used in such an environment. Immunity Test...
  • Page 141 RF communication equipment and EasyOne Pro™ EasyOne Pro™ is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled. The customer or the user of EasyOne Pro™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and EasyOne Pro™...
  • Page 142 Any supplied accessories that do not affect EMC compliance are not included. Ethernet cable, 1.5 m, shielded USB cable, 2 m, shielded VGA cable including 2 ferrites, 1.8 m, shielded Sensor cable, 1.7 m, shielded Temperature / humidity sensor cable, 0.4 m, shielded EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 143: Microsoft Software License Terms For Windows® Xp Embedded Runtime

    Software that provides consumer or business tasks or processes may not be run on the device. This includes email, word processing, spreadsheet, database, scheduling and personal finance software. The device may use terminal services protocols to access such software running on a server. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 144 Remote Boot Installation Service (RBIS) tool only to  install one copy of the software on your server and to deploy the software on licensed devices as part of the Remote Boot process; EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 145 Auto Root Update. The Auto Root Update feature updates the list  of trusted certificate authorities. You can switch off the Auto Root Update feature. Windows Media Player. When you use Windows Media Player, it  checks with Microsoft for EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 146 Certificate of Authenticity label with a genuine copy of the software identifies licensed software. To be valid, this label must be affixed to the device, or included on or in ndd EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 147 13. Export Restrictions. The software is subject to United States export laws and regulations. You must comply with all domestic and international export laws and regulations that apply to the software. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 148 Appendix These laws include restrictions on destinations, end users and end use. For additional information, see www.microsoft.com/exporting. EasyOne Pro™ / EasyOne Pro™ LAB...

  • Page 149: Quick Reference Guide To The Screen Displays

    'Sensor connected' patient indicator Also refer to "Safety Information" on page 6 "Start-up and Initial Preparation" on page 19 "Performing a Test" on page 40 "System Settings" on page 99 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 150 Click to edit the patient data with the selected patient Also refer to "Selecting/Adding a Patient" on page 40 "Editing Patient Data" on page 71 "Selecting a Test" on page 44 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 151 Click to close the the menu window, saving the options data Also refer to "Selecting/Adding a Patient" on page 40 "Editing Patient Data" on page 71 "Selecting a Test" on page 44 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 152 44 "Forced Vital Capacity (FVC/FVL)" on page 45 "Vital Capacity (SVC)" on page 55 "Maximum Voluntary Ventilation (MVV)" on page 57 "CO Diffusing Capacity (DLCO)" on page 59 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 153 Click to close the window indicator without saving the data Also refer to "FVL Test (inspiratory and expiratory measurement)" on page 51 "Components and Functional Description of EasyOne Pro™" on page 15 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 154 Click to view the test Also refer to "Retrieving/Printing Stored Tests" on page 66 "Quality Messages and Quality Grades" on page 72 "Connecting the Printer" on page 30 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 155 Click to view the test indicator Also refer to "Retrieving/Printing Stored Tests" on page 66 "System Settings" on page 99 "Quality Messages and Quality Grades" on page 72 "Connecting the Printer" on page 30 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 156 Also refer to "Retrieving/Printing Stored Tests" on page 66 "System Settings" on page 99 "Quality Messages and Quality Grades" on page 72 "Connecting the Printer" on page 30 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 157 Also refer to "Retrieving/Printing Stored Tests" on page 66 "System Settings" on page 99 "Quality Messages and Quality Grades" on page 72 "Connecting the Printer" on page 30 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 158 Also refer to "Retrieving/Printing Stored Tests" on page 66 "System Settings" on page 99 "Quality Messages and Quality Grades" on page 72 "Connecting the Printer" on page 30 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 159 Icon to initiate the trend printout Click to view Help button Selected patient data 'Sensor connected' patient indicator Also refer to "Trend View" on page 69 "Definition of Important Parameters" on page 85 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 160 Click to wBreath calibrate the Back to program Selected touch screen main menu Click to view patient patient data 'Sensor connected' indicator Also refer to "System Settings" on page 99 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 161 Help button Click to view Selected patient data patient 'Sensor connected' Back to main indicator menu Also refer to "System Settings" on page 99 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 162 Back to Click to show/hide main menu the keypad Also refer to "Calibration Check" on page 162 "EasyOne Pro™ Flow Sensor Design and Operation" on page 16 "Specifications" on page 117 "Index" on page 167 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 163 Click to conduct a new test Click to display the reference / control values Also refer to "Calibration Check with Test Subject" on page 163 "EasyOne Pro™ Flow Sensor Design and Operation" on page 16 "Specifications" on page 117 "Index" on page 167...

  • Page 164: Easyone Pro Lab Washout Moment Analysis

    Appendix 12.10 EasyOne Pro LAB Washout Moment Analysis The parameters Moment value (M0), Moment ratio 1 (MR1) and Moment ratio 2 (MR2) are calculated from measured values recorded during the multi-breath nitrogen washout test. Calculation of these parameters is defined in a paper published by Shao et al. [17].

  • Page 165: Literature

    Manual, American Thoracic Society, New York, NY 10019. Enright PL, Hyatt RE. Office Spirometry. Lea & Febiger, Philadelphia, 1987. Hyatt, RE, Scanlon PD, Nakamura M. Interpretation of Pulmonary Function Tests - A Practical Guide. Lippincott - Raven, Philadelphia, 1997. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 166 R Kraemer, B Meister. Fast real-time moment-ratio analysis of multibreath nitrogen washout in children. J Appl Physiol 59(4): 1137-1144, 1985. [21] J Saniie, GM Saidel, EH Chester. Real-time moment analysis of pulmonary nitrogen washout. J Appl Physiol, 46(6): 1184-1190, 1979. EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 167 ATPS values..... . 51 EasyOne Pro LAB ....12 EasyOne Pro LAB, functions .
  • Page 168 Patient, selection ....40, 41 Transport damage ....19 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 169 Warning (definition) ....8 Warranty ......7 EasyOne Pro™ / EasyOne Pro™ LAB...
  • Page 170 Medical Technologies ndd Medizintechnik AG Two Dundee Park Technoparkstr. 1 Andover, MA 01810 CH-8005 Zürich Switzerland www.nddmed.com www.ndd.ch...

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