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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™...
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...
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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...
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.
This manual is an integral part of the device. It should be available to the equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety. Please note EasyOne Pro™ / EasyOne Pro™ LAB...
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The power cord must be an approved type acceptable to the authorities in the country where the equipment is used. EasyOne Pro™ must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site.
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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.
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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.
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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...
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- general clinical instability of the patient - severely reduced lung function - treatment with beta blockers - hyperresponsiveness - pregnancy. A physician or specially trained staff must be present while bronchial provocation tests are being performed. EasyOne Pro™ / EasyOne Pro™ LAB...
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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).
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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...
Temperature and humidity sensor. 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 manufac- ture in the YYYY-MM format. Manufacturer EasyOne Pro™ / EasyOne Pro™ LAB...
The ndd EasyOne Pro™ Respiratory Analysis System is designed for con- ducting 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.
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)
Introduction EasyOne Pro™ consists of a compact main unit and a hand-held flow sen- sor S with removable DLCO valve unit Q. The hand-held sensor is electrically connected to the device. For DLCO tests, a gas supply tube P delivers gas to the DLCO valve.
Patient Hazard, Incorrect Measurements— Observe local regulations. Use only medical-grade gases, if required. Make sure that only ndd-approved gas mixtures are used. If the gases used do not meet the ndd specifications, equipment malfunction may occur and the test results may be incorrect.
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), 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...
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"...
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 sen- f Sensor (see Fig. 2-3) EasyOne Pro™ / EasyOne Pro™ LAB...
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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...
DLCO barriette™ or for LAB FRC barri- t Overpressure valves ette™ 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...
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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...
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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...
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...
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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;...
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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...
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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. Note Observe the information given in the section "Test Gas Requirements" on page 18. Pressurised Gas Cylinder...
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Port for EasyOne Pro™ LAB connection c Pressure relief valve, secondary side tube (FRC gas) 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;...
10 bar! 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).
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Fig. 2-14 Printer tab Printing with HP Universal Printing PCL5 (network printer) In the drop-down list, select "HP Universal Printing PCL" and confirm with Select the test to print. Fig. 2-15 Test selection EasyOne Pro™ / EasyOne Pro™ LAB...
Equipment Damage—Before connecting the device to the power line, verify that the ratings of your local power line are those indicated on the device nameplate. Warning Shock Hazard—Do not use this equipment unless it is properly connected to earth ground. EasyOne Pro™ / EasyOne Pro™ LAB...
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Start-up and Initial Preparation Use only the original ndd power cord supplied with the device. If the device is used within a medical system, it must be connected with the room's central potential equalization system (pin a, Fig. 2-18). Using improperly grounded equipment could result in serious injury or death and severe damage to the equipment and interconnected equipment.
Note The valve unit is only required for DLCO and FRC tests. All other tests are performed without the valve unit. The device is to be operated only with the original ndd DLCO barriette™. Warning Cross Contamination Between Patients—The DLCO barriette™...
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EasyOne Pro™ LAB. If the EasyOne Pro™ LAB is used for DLCO testing, the DLCO barriette™ will also have to be attached here. The device is to be operated only with the original ndd FRC barriette™. Warning Cross Contamination Between Patients—The FRC barriette™...
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Start-up and Initial Preparation Fig. 2-21 Inserting the FRC barriette™ spirette™ Note The device is to be operated only with the original ndd spirette™. Warning Cross Contamination Between Patients—The spirette™ is intended for single patient use. Use a new one for each patient to prevent cross contamination between patients.
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.
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Click to quit the program e Click to review the results from previ- 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.
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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...
Click to edit the selected patient's data j Additional parameters g Click to delete the data of the selected k Back to main menu EasyOne Pro™ / EasyOne Pro™ LAB...
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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...
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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...
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Use Drag & Drop (right mouse button) to merge data records. Fig. 3-5 Merging a patient’s data records EasyOne Pro™ / EasyOne Pro™ LAB...
EasyOne when performing tests and the subsequent synchronization. Refer to the EasyOne tab (see "EasyOne Tab" on page 125) for configuration options. Fig. 3-7 Selection screen when the selected device is EasyOne EasyOne Pro™ / EasyOne Pro™ LAB...
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...
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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.
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This is necessary to set the baseline correctly. Note ndd recommends leaving the spirette™ packaging in place until after the baseline has been set. Block off the spirette™ on one end and confirm the message with OK.
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The test quality depends on the co-opera- tion of the patient which, in turn, depends on the quality of the physician's instructions. EasyOne Pro™ incorporates an automatic quality control func- tion. This function analyzes the test quality and displays a message to inform you as to whether the maneuver was acceptable or not (see "System...
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FVC, FEV1 and FEV1/ FVC are displayed in color, all other parameters are grey. Fig. 3-12 %Pred graph EasyOne Pro™ / EasyOne Pro™ LAB...
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Before the inspiratory test can be started, a window pops up with these data. Check the data. For the pending test you can now edit the data, if nec- essary, or confirm them, if they are correct. EasyOne Pro™ / EasyOne Pro™ LAB...
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fill lungs completely exhale as hard and fast as possible continue blowing out until the lungs are completely empty inhale as hard and fast as possible. EasyOne Pro™ / EasyOne Pro™ LAB...
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As soon as three acceptable trials have been performed, the message Ses- sion complete! appears and a quality grade from A (optimal) to F is dis- played (see "Quality Messages and Quality Grades" on page 84). EasyOne Pro™ / EasyOne Pro™ LAB...
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Performing a Test Fig. 3-16 Acquisition screen after three acceptable post-trials EasyOne Pro™ / EasyOne Pro™ LAB...
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(see "General Tab" page 111). 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...
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...
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Click for a retrospective test evaluation or to expand the parameter list (see Conduct the tests as described in section "Measurement" on page 48. EasyOne Pro™ / EasyOne Pro™ LAB...
and as fast as possible over a period of 12 seconds. Select MVV. The MVV acquisition screen appears. EasyOne Pro™ / EasyOne Pro™ LAB...
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Click for a retrospective test evaluation or to expand the parameter list (see Conduct the tests as described in section "Measurement" on page 48. Fig. 3-22 Acquisition screen after two acceptable MVV tests EasyOne Pro™ / EasyOne Pro™ LAB...
Fabbri LM, Quanjer PhH, et al. Airway responsiveness. Standardized challenge testing with pharmacological, physical and sensitizing stimuli in adults. Report Working Party Standardization of Lung Function Tests. European Community for Steel and Coal. Official position of the EasyOne Pro™ / EasyOne Pro™ LAB...
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The baseline is determined either at the pre-test stage or at the 0 mg/ml level, depending on the test protocol. Three acceptable FEV1 measurements should be available for the baseline determination (see "Forced Vital Capac- ity (FVC/FVL)" on page 46). Click Start to initiate the measurement. EasyOne Pro™ / EasyOne Pro™ LAB...
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If a reduced lung function is determined, the physician needs to decide if and how to continue the test. With Menu d, you can display a number of keys and then return to the FVC acquisition screen with Spirometry, for example. EasyOne Pro™ / EasyOne Pro™ LAB...
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(response curve) at any time during the test. Click Protocol to display the protocol screen: the measurement and the next step will be displayed and the next action shown in this example is Administer 0.0625 mg/mL concentration. EasyOne Pro™ / EasyOne Pro™ LAB...
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(Post) and the next action Administer a bronchodilator will be displayed. Note Some protocols require the administration of a bronchodilator even for tests with a negative result. Fig. 3-28 Protocol screen with a positive test result EasyOne Pro™ / EasyOne Pro™ LAB...
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After the test, the patient should leave the laboratory only after the obstruction is reversed either spontaneously or upon administration of a bronchodilator substance. The reversal should be documented with a lung function test. EasyOne Pro™ / EasyOne Pro™ LAB...
Click Quick Test and perform the test as usual. Note It is not possible to edit the predicted values retrospectively once measurements have been taken. The Quick Test feature is not available for DLCO tests. EasyOne Pro™ / EasyOne Pro™ LAB...
Instruct the patient to hold the sensor straight (not at an angle) in front of his or her mouth without taking the spirette™ into the mouth yet. Fig. 3-31 shows the patient during a test, using the sensor stand (optional accessory). EasyOne Pro™ / EasyOne Pro™ LAB...
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Performing a Test Fig. 3-31 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 Test preparation Tidal breathing When you see the message Start tidal breathing, instruct the patient to ...
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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). With Collection Bar i you can show and hide control buttons for the collec- tion bar (j, k, m). EasyOne Pro™ / EasyOne Pro™ LAB...
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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...
Performing a Test 3.9 FRC Test (EasyOne Pro™ LAB only) Introduction 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.
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Instruct the patient according to the displayed on-line messages. The messages depend on the mode settings "Automatic" or "Manual" and on the selected option "Linked SVC". Attach the FRC barriette™ (see "FRC Test (EasyOne Pro™ LAB only)" page 71). Select the patient (see "Selecting/Adding a Patient"...
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2 % (as configured under "FRC (mbw) Tab" on page 122). In manual mode, beginning and end of the Washout phase must be manu- ally determined. After a successful test, the message Good effort will be displayed. EasyOne Pro™ / EasyOne Pro™ LAB...
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Volume-time curve (only shown for page 122) "linked" measurements) f Flow indicator (during the washout d Click to enter a comment phase, the flow should remain in the green range) Fig. 3-34 FRC test (online linked) EasyOne Pro™ / EasyOne Pro™ LAB...
(see "Hygiene, Cleaning, Maintenance, Disposal" on page 100). 3.11 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 ...
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Print to print the test, or Trend to view the trend display (see on page 78). Click Patients to display the patient list and "Trend View" click New Test to display the test selection menu. Note Alternative: Double-click on a test to display it. EasyOne Pro™ / EasyOne Pro™ LAB...
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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 Fig. 3-38 Menu bar when the Print Menu button is pressed EasyOne Pro™ / EasyOne Pro™ LAB...
Fig. 3-39 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...
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Performing a Test Fig. 3-40 Trend view of a single parameter and its predicted normals EasyOne Pro™ / EasyOne Pro™ LAB...
VCex Expiratory Vital Capacity expiratory vital capacity of a slow spirometric test VCin Inspiratory Vital Capacity inspiratory vital capacity of a slow spirometric test Vital Capacity vital capacity of a slow spi- rometric test EasyOne Pro™ / EasyOne Pro™ LAB...
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Krogh Factor Krogh factor Total Lung Capacity total lung capacity Note The parameter names used by ndd Medizintechnik AG are those standardized by ATS and ERS. (See literature references [14] and[11] ("Literature" on page 182). For forced spirometric tests and depending on your configuration, the "Best"...
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...
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...
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('Start maneuver …') played) Cough detected. Try A cough has been detected (PEF or Instruct the patient to avoid again… PIF >19 l/s) coughing during the measure- ment. Repeat the test. EasyOne Pro™ / EasyOne Pro™ LAB...
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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...
Session Complete! QC grade A, VC variability 150 ml The test is complete. An adequate Great Job! and at least 3 acceptable trials number of good tests is available. available. EasyOne Pro™ / EasyOne Pro™ LAB...
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...
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Test error: # of Number of breaths during DLCO Perform the DLCO maneuver with breaths expiration could not be detected full effort Test cannot be evalu- ated; DLCO maneu- ver cannot be detected EasyOne Pro™ / EasyOne Pro™ LAB...
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(clip) please contact service. CO sensor drift too CO drift during measurement Repeat the test. If the error occurs high > 150 ppm again after the device has warmed-up, then please contact service. EasyOne Pro™ / EasyOne Pro™ LAB...
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General error in DLCO calculation If the error occurs repeatedly, then please contact service. DLCO warning: High CO drift during measurement The test result must be interpreted CO sensor drift! > 60 ppm with caution EasyOne Pro™ / EasyOne Pro™ LAB...
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Quality Messages and Quality Grades DLCO Acceptability and Quality Grades Currently, there are not standardized quality grades for DLCO tests. These are the quality grades implemented in EasyOne Pro™ LAB: Quality Grade Accept. Trials DLCO Variability >=2 <1 ml/min/mmHg >=2 <2 ml/min/mmHg...
1) Insufficient pressure at the O2 Ask the patient to breathe within gas port. the limits of ±1.5 l/s. 2) Patient's breaths are too deep; the respiratory resistance and thus the pressure drop increase from about 2 l/s. EasyOne Pro™ / EasyOne Pro™ LAB...
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FRC(MBW) Error: Not The number of breaths required FRC test was stopped prematurely. enough breaths for for calculation of FRC was not washout computa- reached. tion! EasyOne Pro™ / EasyOne Pro™ LAB...
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(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...
You can view the test result on the monitor as soon as you see message Session Complete! after performing a test. Fig. 5-1 Test results, system interpretation a Pre-medication test results c System interpretation b Quality grade d Post-medication test results and devia- tion from Pre-test results EasyOne Pro™ / EasyOne Pro™ LAB...
Follow these steps to make a test acceptable that the system judged unac- ceptable: Click the icon. In the ensuing window, select the Acceptable check box. Fig. 5-3 Changing the trial ranking EasyOne Pro™ / EasyOne Pro™ LAB...
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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...
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.
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...
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Particularly inspect the gas cylin- der(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...
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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 99).
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Hygiene, Cleaning, Maintenance, Disposal Software Update The files necessary for a software update are made available by ndd. For a detailed description of the installation procedure, please go to www.ndd.ch, Application Note “Update EasyOne Pro Firmware” or “Update EasyOne Pro- LAB Firmware”.
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"Calibration Check with Test Subject" page 107). The EasyOne Pro™ calibration can be checked with a syringe using the cali- bration check function. The American Thoracic Society (ATS) recommends that the spirometer calibration be checked on a regular basis. Owing to the ultrasound technology used in the flow sensor, the device requires no cali- bration, even if used frequently.
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"Troubleshooting Tips" on page 130. Should you not be able to remedy the defect by following these instructions either, please con- sult ndd or one of their representatives. Fig. 7-3 Calibration syringe DLCO Calibration Check The American Thoracic Society (ATS) recommends checking DLCO calibra- tion on a weekly basis or whenever irregularities are suspected.
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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 func- tionality. EasyOne Pro™ / EasyOne Pro™ LAB...
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These tests are observed and statistically controlled, if they are within an expected range. The data is collected on individual healthy, non-smoking BioCal Subjects (e.g. physician, respiratory therapist, …). Note Also refer to www.ndd.ch. Application Note "DLCO Bio- Calcheck EasyOne Pro". Fig. 7-4 BioCal Check main screen a Sensor selection...
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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...
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 concern- ing the decommissioning of your equipment. EasyOne Pro™ / EasyOne Pro™ LAB...
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...
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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...
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Click to import a database f Click to perform a data backup c Click to copy data from/to a storage g Click to select the database folder medium d Path and name of the currently used database folder EasyOne Pro™ / EasyOne Pro™ LAB...
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Select the scroll bar width to always view all possible test and h Adjust the volume device settings, or deselect c Click to select the regional settings (date and time format) EasyOne Pro™ / EasyOne Pro™ LAB...
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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...
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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...
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Select/deselect the system interpreta- again tion i Boxes for entry of correction factors e Curve selection criteria (see Note below) f Select this check box, if you want to stop tests manually EasyOne Pro™ / EasyOne Pro™ LAB...
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Other parameters are taken from the highest ranked trial (= 1). For DLCO tests, the "Best Value" / "Best Trial" selection is irrelevant. The values are calculated from the average of all accepted trials. EasyOne Pro™ / EasyOne Pro™ LAB...
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Follow these steps to remove a parameter from the list select it in the "Selected" list c click d to remove it from the list. Click e to scroll the list up and down. EasyOne Pro™ / EasyOne Pro™ LAB...
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System Settings 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...
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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...
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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...
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8-10) or the "Activate" button will be dis- e Choose the tracer curve format played for manually starting the test f Click to enable/disable tests linked with SVC EasyOne Pro™ / EasyOne Pro™ LAB...
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System Settings Provocation Tab You select the test protocol from this tab. Fig. 8-15 Provocation tab EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to switch the pump manually off e Click to select the sensor port from the and on dropdown list c Click to release pressure if the gas cylin- der has to be exchanged EasyOne Pro™ / EasyOne Pro™ LAB...
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Test Configuration General Configuration Report Configuration Consult the EasyOne operator manual for details. Fig. 8-17 EasyOne tab Selection Tab Select your preferred sensor type on this tab. Fig. 8-18 Selection tab EasyOne Pro™ / EasyOne Pro™ LAB...
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On the Report tab, you can: display the Report Designer (Layout Editor, see "Report Designer" page 150) a load layouts (Load layout, also refer to www.ndd.ch. Application Note "EasyOne Pro import Layout") b save layouts (Export layout) c ...
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After connection of the printer you select the printer driver on this tab (see "Connecting the Printer" on page 31). Fig. 8-20 Printer tab a Press to open the printer list c Select the default printer b Press to update the printer list EasyOne Pro™ / EasyOne Pro™ LAB...
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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 EMR system. EasyOne Pro™ / EasyOne Pro™ LAB...
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Recalculate BTPS conversion factor BTPS conversion) (e.g. after a change of the ambient con- e Select the check box, if you do not want ditions) to enter ambient conditions for two hours or until a restart. Otherwise, EasyOne Pro™ / EasyOne Pro™ LAB...
Configuration > Test > ume. 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...
(LAB only) Measuring range 0 to 15% Resolution 0.005% Accuracy from 0 to 5%:±0.05% from 5 to 10%:±0.20% >10%: not specified Mouth pres- Measuring range ±100 mbar sure trans- Accuracy ±5% ducer EasyOne Pro™ / EasyOne Pro™ LAB...
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However, where the device contains oxygen rich environments, it complies with applicable requirements for fire pre- vention. Operating 100 to 240 V, 50 to 60 Hz voltage range EasyOne Pro™ / EasyOne Pro™ LAB...
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Specifications Power con- 80 VA sumption [max.] Life time 7 years EasyOne Pro™ / EasyOne Pro™ LAB...
The automatic system interpretation can be selected and deselected on the configuration tab (see "General Tab" on page 111). GOLD-Hardie Interpretation The following diagram outlines the criteria EasyOne Pro™ applies in the automatic interpretation after GOLD/HARDIE (see "Literature" on page 182 [12], [13]).
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Appendix NLHEP Interpretation The following diagram outlines the criteria EasyOne Pro™ applies in the automatic interpretation after NLHEP (see "Literature" on page 182 [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.
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(partial update). NICE clinical guideline 101. The NICE 2010 interpretation according to this algorithm (Fig. 12-1) does not detect restrictive disorders. Our application, however, always identifies restrictive disorders if FVC and FEV1 < LLN. EasyOne Pro™ / EasyOne Pro™ LAB...
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...
12.3 GDT Interface Introduction The following describes the interface set up to facilitate the data communi- cation between EasyOne Pro™ and an Electronic Medical Record System (EMR). As an example the integration of the German GDT standard is described. Software Settings...
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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™.
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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™.
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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...
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Appendix View of tests with EasyOne Pro™ View test via GDT record type 6311 with patient name, ID and date and time of test Record type 6311 is supported. In the transmission of test results using GDT record type 6310, field IDs 8432 (date) and 8439 (time) are always...
(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...
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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...
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...
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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...
On the Report Designer tab, select New Report (Fig. 12-3: left). Fig. 12-3: New Report button (left), test selection (right) Select the test to which you want to add the logo (Fig. 12-3: right). EasyOne Pro™ / EasyOne Pro™ LAB...
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Appendix Select the Picture Box (Fig. 12-4:). Fig. 12-4: Picture Box button Insert the frame in the appropriate position (Fig. 12-5:). Fig. 12-5: Positioning the frame EasyOne Pro™ / EasyOne Pro™ LAB...
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Select the test via New Report or Open. Fig. 12-7: New Report, Open buttons Select Windows and then Report Explorer (Fig. 12-8:). Select Detail Report Graph (Fig. 12-8:). Click graphVT1. EasyOne Pro™ / EasyOne Pro™ LAB...
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Choose options in the Trial Selection pane. Choose options in the Appearance pane. Fig. 12-10: Spiro Graph Configuration window Close the window with OK. Save the test under a new name. EasyOne Pro™ / EasyOne Pro™ LAB...
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...
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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...
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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...
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To assess the electromagnetic envi- ronment due to fixed RF transmitters, an electromagnetic site survey should be con- sidered. If the measured field strength in the location in which EasyOne Pro™ is used exceeds the applicable RF compliance level above, EasyOne Pro™ should be observed to verify normal operation.
12.8 Microsoft Software License Terms for Windows Embedded Runtime These license terms are an agreement between you and ndd Medizintech- nik AG. Please read them. They apply to the software included on this device. The software also includes any separate media on which you received the software.
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By using the software, you accept these terms. If you do not accept them, do not use or copy the software. Instead, contact ndd Mediz- intechnik AG to determine its return policy for a refund or credit. If you comply with these license terms, you have the rights below.
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Appendix only in certain ways. For more information, see the software documentation or contact ndd Medizintechnik AG. Except and only to the extent permitted by applicable law despite these limitations, you may not: Work around any technical limitations in the software;...
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If you decline an upgrade, you will not be able to access content that requires the upgrade. You may switch off WMDRM features that access the Internet. When these features EasyOne Pro™ / EasyOne Pro™ LAB...
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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 Medizintechnik AG's software packaging. If you receive the label separately, it is not valid.
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Microsoft or its affiliates. When allowed by your local laws, ndd Medizintechnik AG and Microsoft exclude implied warranties of merchantability, fitness for a particular purpose and non-infringement.
'Sensor connected' indi- patient cator Also refer to "Safety Information" on page 6 "Start-up and Initial Preparation" on page 20 "Performing a Test" on page 41 "System Settings" on page 110 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to edit the patient data with the selected patient Also refer to "Selecting/Adding a Patient" on page 41 "Editing Patient Data" on page 83 "Selecting a Test" on page 45 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to close the win- the menu dow, saving the data options Also refer to "Selecting/Adding a Patient" on page 41 "Editing Patient Data" on page 83 "Selecting a Test" on page 45 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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45 "Forced Vital Capacity (FVC/FVL)" on page 46 "Vital Capacity (SVC)" on page 56 "Maximum Voluntary Ventilation (MVV)" on page 58 "CO Diffusing Capacity (DLCO)" on page 67 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to close the window cator 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 16 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to view the test Also refer to "Retrieving/Printing Stored Tests" on page 75 "Quality Messages and Quality Grades" on page 84 "Connecting the Printer" on page 31 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to view the test cator Also refer to "Retrieving/Printing Stored Tests" on page 75 "System Settings" on page 110 "Quality Messages and Quality Grades" on page 84 "Connecting the Printer" on page 31 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Also refer to "Retrieving/Printing Stored Tests" on page 75 "System Settings" on page 110 "Quality Messages and Quality Grades" on page 84 "Connecting the Printer" on page 31 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Also refer to "Retrieving/Printing Stored Tests" on page 75 "System Settings" on page 110 "Quality Messages and Quality Grades" on page 84 "Connecting the Printer" on page 31 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Also refer to "Retrieving/Printing Stored Tests" on page 75 "System Settings" on page 110 "Quality Messages and Quality Grades" on page 84 "Connecting the Printer" on page 31 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Also refer to "Retrieving/Printing Stored Tests" on page 75 "System Settings" on page 110 "Quality Messages and Quality Grades" on page 84 "Connecting the Printer" on page 31 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Icon to initiate the trend printout Click to view Help button Selected patient data 'Sensor connected' indi- patient cator Also refer to "Trend View" on page 78 "Switching the Device Off" on page 99 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to cali- wBreath brate 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 110 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Help button Click to view Selected patient data patient 'Sensor connected' Back to main indicator menu Also refer to "System Settings" on page 110 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Back to Click to show/hide main menu the keypad Also refer to "Calibration Check" on page 178 "EasyOne Pro™ Flow Sensor Design and Operation" on page 17 "Specifications" on page 131 "Index" on page 185 EasyOne Pro™ / EasyOne Pro™ LAB...
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Click to conduct a new test Click to display the refer- ence / control values Also refer to "Calibration Check with Test Subject" on page 179 "EasyOne Pro™ Flow Sensor Design and Operation" on page 17 "Specifications" on page 131 "Index" on page 185...
The following picture shows a diagram of A versus dilution number ( ) (see "Literature" on page 182 [17]). In Moment Analysis the r moment can be defined as EasyOne Pro™ / EasyOne Pro™ LAB...
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Moment analysis has been described by several authors (see "Literature" on page 182 [17] to [21]). Clinical use of Moment Analysis is still limited since reference values from larger groups are not yet available. EasyOne Pro™ / EasyOne Pro™ LAB...
Eur Respir J2002;20: 1117-1122. [14] ATS/ERS Task Force: Standardization of Lung Function Testing; Eur Respir J 2005;26:153–161. [15] N. Beydon, S.D. Davis et al.; An Official American Thoracic Society/ European Respiratory Society Statement: Pulmonary Function Test- EasyOne Pro™ / EasyOne Pro™ LAB...
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R Kraemer, B Meister. Fast real-time moment-ratio analysis of multi- breath nitrogen washout in children. J Appl Physiol 59(4): 1137- 1144, 1985. [21] J Saniie, GM Saidel, EH Chester. Real-time moment analysis of pul- monary nitrogen washout. J Appl Physiol, 46(6): 1184-1190, 1979. EasyOne Pro™ / EasyOne Pro™ LAB...
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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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