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Appendix

162

EasyOne Pro™ / EasyOne Pro™ LAB

 

are off, you can still play content for which you have a valid 
license.

Misuse of Internet-based Services.

 You may not use these services 

in any way that could harm them or impair anyone else's use of them. 
You may not use the services to try to gain unauthorized access to any 
service, data, account or network by any means.

4.

Windows Update Agent (also known as Software Update Services).

 

The software on the device includes Windows Update Agent ("WUA") 
functionality that may enable your device to connect to and access 
updates ("Windows Updates") from a server installed with the required 
server component. Without limiting any other disclaimer in this 
Microsoft Software License Terms or any EULA accompanying a 
Windows Update, you acknowledge and agree that no warranty is 
provided by MS, Microsoft Corporation or their affiliates with respect to 
any Windows Update that you install or attempt to install on your 
device.

5. 

Product Support.

 Contact 

ndd Medizintechnik AG

 for support options. 

Refer to the support number provided with the device.

6.

Backup Copy.

  You may make one backup copy of the software. You 

may use it only to reinstall the software on the device.

7.

Proof Of License.

 If you acquired the software on the device, or on a 

disc or other media, a genuine 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. You should keep the label on the device or 
packaging to prove that you are licensed to use the software. To 
identify genuine Microsoft software, see http://www.howtotell.com.

8.

Transfer to a Third Party.

  You may transfer the software only with the 

device, the Certificate of Authenticity label, and these license terms 
directly to a third party. Before the transfer, that party must agree that 
these license terms apply to the transfer and use of the software. You 
may not retain any copies of the software including the backup copy.

9.

Not Fault Tolerant.

 The software is not fault tolerant. 

ndd 

Medizintechnik AG

 installed the software on the device and is 

responsible for how it operates on the device.

10.

Restricted Use.

 The Microsoft software was designed for systems that 

do not require fail-safe performance. You may not use the Microsoft 
software in any device or system in which a malfunction of the software 
would result in foreseeable risk of injury or death to any person. This 
includes operation of nuclear facilities, aircraft navigation or 
communication systems and air traffic control.

11.

No Warranties for the Software. The software is provided "as is". 
You bear all risks of using it. Microsoft gives no express 
warranties, guarantees or conditions. Any warranties you receive 

Summary of Contents for easyone pro

Page 1: ...Version V04b EasyOne Pro EasyOne Pro LAB Operator s Manual ...

Page 2: ...go 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 LAB are accompanied by the symbol shown at left and by the word LAB ndd Medizintechni...

Page 3: ...Equipment Description 21 2 3 Preparing the Device 23 2 4 Gas Supply 26 2 5 Connecting the Keyboard and the Mouse 31 2 6 Connecting the Printer 31 2 7 Power 33 2 8 Inserting the One Way Valve DLCO barriette FRC barriette and spirette 35 2 9 Switching the Device On Functional Test 38 3 Performing a Test 41 3 1 Selecting Adding a Patient 41 3 2 Selecting a Test 45 3 3 Forced Vital Capacity FVC FVL 46...

Page 4: ...intenance Disposal 100 8 System Settings 110 9 Troubleshooting Tips 130 10 Specifications 131 11 Order Information 134 12 Appendix 135 12 1 Interpretation 135 12 2 Predicted Values 139 12 3 GDT Interface 140 12 4 Introduction to Adjustment of DLCO Measurements 146 12 5 How to interpret TLC from a single breath maneuver 148 12 6 Report Designer 150 12 7 Electromagnetic Compatibility EMC 154 12 8 Mi...

Page 5: ...pment The radio interference emitted by EasyOne Pro is within the limits specified in EN 55011 class B The CE marking covers only the accessories listed in the Order Information chapter Magnetic and electrical fields are capable of interfering with the proper performance of the device For this reason make sure that all external devices operated in the vicinity of the equipment comply with the rele...

Page 6: ...and product names are italicized e g Last Name First Name EasyOne Pro 1 6 Safety Information General Information 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 E...

Page 7: ...nents and accessories must comply with the applicable IEC 60601 safety standards and or the configured system must comply with the collateral standard IEC 60601 1 1 Requirements for the safety of medical electrical systems 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 stora...

Page 8: ...hazard If not avoided the hazard may result in minor injury and or product property damage 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 Great care must be exercised when the system is used in an oxy...

Page 9: ...he devices to the power line Printers operated in the patient vicinity must meet the requirements of IEC 60601 If they do not they must be modified and be connected to earth ground PE potential equalization All devices of a system must be connected to the same power supply circuit Devices that are not connected to the same circuit must be electrically isolated when operated e g with an isolated RS...

Page 10: ...e content and use of all custom configured reports Patient Hazard Do not touch the accessible contacts of connectors located at the rear panel and the patient at the same time Patient Hazard Equipment Damage Do not modify EasyOne Pro in any way Patient Hazard When used at 230 240 V 60 Hz equipment must be connected to a center tapped 240 V single phase transformer US requirement Risk of Infection ...

Page 11: ...of the packaging material observing the applicable waste control regulations Keep the packaging material out of children s reach Danger Patient hazard Observe the following points when performing bronchial provocation tests Bronchial provocation tests can be dangerous for patients A primary condition for safe provocation test procedures is a trained and experienced physician Above all these physic...

Page 12: ...uropean Respiratory Society Eur Respir J 1993 6 Suppl 16 53 83 Caution Equipment Damage Before connecting the device to the power line check that the voltage and frequency ratings of your power line match the values indicated on the device nameplate Equipment Damage Protect the equipment from viruses malware etc Always check the USB flash drive for viruses before connecting it to the equipment Equ...

Page 13: ...sk of fire smoking and open flames are prohibited Possible sources of ignition must be eliminated Rooms must be well ventilated The oxygen inlet must periodically be checked for leaks at least once a month Use only fittings approved for use with oxygen these fittings must be properly connected All fittings downstream lines and devices must be free of oil and grease Connect a pressure relief valve ...

Page 14: ...2 EEC of the European Union Product certification for the USA and Canada Connection to power line ON mains power switch Connection to power line OFF mains power switch 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 0120 ...

Page 15: ... in the presence of carbon monoxide toxicity in case of dangerous levels of oxyhemoglobin desaturation without supplemental oxygen 1 9 Additional Functions of EasyOne Pro LAB EasyOne Pro LAB includes the measurement of the FRC Functional Resid ual Capacity based on the Multiple Breath Nitrogen N2 Washout method This method is based on washing out the N2 from the lungs while the patient breathes 10...

Page 16: ...dard PC F PC ports USB LAN etc G Automatic data acquisition H Sensor for ambient temperature and humidity I Pump J Pneumatic system K Demand valve L CO sensor M Molar mass sensor N Display with touch screen O Replaceable filter pack P Gas supply tubing Q DLCO valve R Motor block S Sensor T Gas cylinder for DLCO tests U Oxygen cylinder for FRC test or wall outlet EasyOne Pro LAB only V Oxygen suppl...

Page 17: ...ivery hose and draws gas samples from the patient s inspiratory and expiratory breath The side stream flow used for gas analysis is driven by a pump I CO gas is analyzed by a sensor based on infrared absorption 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 lo...

Page 18: ...10 helium accuracy 10 0 3 carbon monoxide accu racy 10 18 to 25 oxygen balance nitrogen DLCO simulator test require gas mixtures with an accuracy 2 Note You can purchase all necessary gases and cylinders as well as the fittings from your local supplier of medical gases Equipment not intended for mobile use can also be used with large gas cylinders Use only the supplied original tubing to connect t...

Page 19: ...isible at all times Valves fittings connections and tubing must be free of oil and grease Have the cylinder inspected regularly by an official test authority The user is liable for any damage Close the main valve whenever the gas cylinder is not in use FRC Gas 100 O2 EasyOne Pro LAB only Medical grade oxygen 100 O2 From compressed gas cylinders or the hospital s oxygen supply system Note When usin...

Page 20: ...uire 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 on page 100 Ambient Conditions Excessive amounts of dust lint and miscellaneous clutter around the instrument could result in malfunctions due to internal tubing blockages overhe...

Page 21: ...rt up and Initial Preparation 2 2 Equipment Description Fig 2 1 EasyOne Pro a b c d f e a Sensor holder extendible b Sensor cable connection c Connection for gas supply tube to sen sor d ON OFF switch e Touch stylus f Sensor see Fig 2 3 ...

Page 22: ...Backup on Memory Card on page 102 i LAN ports printer j Monitor k Serial RS232 ports l Connection for temperature and humidity sensor m Connection for tube from DLCO gas cyl inder n Potential equalization pin o Screw to secure the filter pack must be removed before the filter can be replaced p Nameplate q Mains connector mains power switch r Connection for O2 gas supply system EasyOne Pro LAB only...

Page 23: ...ng the Device Connect the sensor cable to the device Fig 2 3 Sensor s t u w x v s Coupling ring for the gas supply tube t Overpressure valves u One way valve v DLCO barriette or for LAB FRC barri ette w Motor block release button x spirette Fig 2 4 Connecting the sensor cable ...

Page 24: ...ect the side of the tube with the colored coupling ring to the device Slip tubing connector onto connection at sensor Screw coupling ring tight Connect the other end of the gas supply tube to the device and tighten the coupling ring Fig 2 5 Connect gas supply tube to valve unit Fig 2 6 Connecting the gas supply tube to the device ...

Page 25: ...sts are performed without the valve unit Pull out the sensor holder on the left side of the device a Fig 2 1 and place the sensor in the holder If you are working with the sensor stand optional accessory you can posi tion the sensor such that the patient is not required to hold it during the tests Using the clamp screw the sensor stand to the table top Open the catch and insert the sensor Close th...

Page 26: ... gas cylinder fittings pressure relief valve must meet the following minimum requirements input pressure on primary side 150 to 300 bar depending on max cylinder pressure output pressure on secondary side 0 to 6 bar flow rate 6 L s minimum You can purchase all necessary gases and cylinders as well as the fittings from your local supplier of medical gases Equipment not intended for mobile use can a...

Page 27: ...the main valve whenever the gas cylinder is not in use Check that the gas meets ndd specifications Check that the main valve a and the pressure relief valve c are closed 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 then advance the tube as far as it will go Note It is important to slide the tube at lea...

Page 28: ...lowly open the pressure relief valve c and set the manometer d to a secondary pressure of 4 to 5 bar Note A DLCO overpressure valve that opens at 7 5 bar is integrated in the device If you select a higher secondary pressure the overpressure valve will open and gas will escape Exchange the gas cylinder if the primary pressure drops below 10 bar Warning Be sure not to confuse the DLCO gas inlet and ...

Page 29: ...r handling of gas cylinders represents a major risk to persons and the environment The relevant regulations must be observed without exception Protect the gas cylinders from falling The content and fill level must be clearly visible at all times Valves fittings connections and tubing must be free of oil and grease Have the cylinder inspected regularly by an official test authority The user is liab...

Page 30: ...the stud exerting sufficient force to overcome the initial resistance then advance the tube until the stop Note It is important to slide the tube at least 19 mm onto the stud To remove the tube push the bushing ring back and pull the tube off the stud If the tube end shows signs of mechanical damage grooves cut off the damaged portion Fig 2 12 Gas cylinder fittings a b d c e a Gas cylinder main va...

Page 31: ...pen and gas will escape Note Exchange the gas cylinder if the primary pressure drops below 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 2 6 Connecting the Printer Depending on the printer used c...

Page 32: ...g PCL5 see below In the main menu select Utilities Configuration Printer Open the printer list and select the printer Printing with HP Universal Printing PCL5 network printer In the drop down list select HP Universal Printing PCL and confirm with OK Select the test to print Fig 2 14 Printer tab Fig 2 15 Test selection ...

Page 33: ...Select the printer to use 2 7 Power Caution 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 Fig 2 16 Printer window Fig 2 17 Printer window ...

Page 34: ...nnected to earth grounded receptacles 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 Leave the mains power switch c on all the time and use the ON OFF switch...

Page 35: ...re 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 is intended for single patient use Use a new one for each patient to prevent cross contamination between patients Attach the one way valve to the valve unit aligning the arrows as shown in Fig 2 19 and turn it clockwise as far as...

Page 36: ...nly 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 The device is to be operated only with the original ndd FRC barriette Warning Cross Contamination Between Patients The FRC barriette is intended for single patient use Use a new one for each patient to prevent cross contamination b...

Page 37: ...ou can insert the spirette in the flow sensor Ensure that the plastic bag protects the mouthpiece of the spirette until you hand the flow sensor over to the patient This approach not only ensures perfectly hygienic conditions it also keeps the spirette closed for subsequent setting of the baseline Insert the spirette as shown in the illustration into the flow sensor as far as possible When doing t...

Page 38: ...r 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 Turn on the device with the power button the green indicator is illuminated After a short start up phase the initial screen will be displayed Note If the initial screen appears and no error messages display the device is in perfect operating condition Fig 2 22 Inserting the spiret...

Page 39: ...ect the test types and parameters Note After each exchange of the gas cylinder check whether the gas concentration in the program corresponds to the specifications on the cylinder Follow these steps Fig 2 24 Initial Screen c fg i a h b d e j a Selected patient b Practice office hospital see General Tab on page 111 for details about entering the data c Click to select a patient or add a new patient...

Page 40: ...rt up and Initial Preparation 40 EasyOne Pro EasyOne Pro LAB 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 ...

Page 41: ...assigned ID e g Q_0033 see Quick Test on page 66 3 1 Selecting Adding a Patient Click Select Patient The patient list will be displayed Fig 3 1 Patient list a c d e i b f h g j k a Selected patient b Bar cursor for patient selection c Click to add a new patient d Click to perform a test with the selected patient e Click to view the selected patient s test results f Click to edit the selected patie...

Page 42: ...e title in the column headers To search for a specific patient you enter the first letter s of the patient s last name at h You select a patient by clicking in the corresponding line of the list the bar cursor highlights the selected patient 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 ...

Page 43: ...he TAB key Also select the ethnic origin b Enter the date of birth height and weight Note The information regarding gender age height weight and ethnic origin must be correct because it is used to calculate the predicted values and to interpret the acquired data Additional information can be entered on the Smoking History see Fig 3 4 History and Comment tabs c Close the window with OK The patient ...

Page 44: ... can merge data records for one and the same patient for example if they were acquired with different tests or if different spellings of the pati ent s name exist Use Drag Drop right mouse button to merge data records Fig 3 4 Smoking History tab Fig 3 5 Merging a patient s data records ...

Page 45: ...erform Test Note If the unit selected is EasyOne see Device Tab on page 124 you will see Fig 3 7 Observe the instructions shown on the monitor screen and on the display of the EasyOne when performing tests and the subsequent synchronization Refer to the EasyOne tab see EasyOne Tab on page 125 for configuration options Fig 3 6 Test selection screen Fig 3 7 Selection screen when the selected device ...

Page 46: ...ient may feel dizzy when performing the test Therefore watch your patients closely if they are standing for the test Fig 3 8 Expiratory FVC acquisition screen b c e i j a f k d h g a Selected test parameters b Predicted values past test results of the patient c Flow volume loop area d Start button e Scaling f Displayed curve selection best trial best trial and pre trial all trials g Show hide the ...

Page 47: ... 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 After a poor effort explain to your patient how to improve the maneuver Caution Ris...

Page 48: ...e 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 When the start test prompt is displayed hand the sensor over to your patient and instruct him or her to perform the maneuver as explained earlier Note If the Manual Test Stop option was selected in the configuration see Test Tab on page 11...

Page 49: ...mplete appears If even after repeated attempts it is not possible to obtain an adequate number of good maneuvers you should take a break depending on how the patient feels or stop the measurement Even after a break the measurement results remain stored Click Add Trial for each subsequent spirometry maneuver A review comment can be entered in area c or the results can be edited do not forget to giv...

Page 50: ...nt bar The left segment a indicates a value below the lower limit of normal the middle segment b represents a value between the lower limit and the predicted value and the right seg ment c indicates a value above the predicted value FVC FEV1 and FEV1 FVC are displayed in color all other parameters are grey Fig 3 11 Acquisition screen after three acceptable expiratory FVC tests a c b a Quality grad...

Page 51: ...acquisition screen will be displayed Perform the new spirometry maneuvers FVL Test inspiratory and expiratory measurement Ambient Conditions The ATPS values Ambient Temperature Pressure Saturated spirometer conditions of inspiratory measurements must be converted to BTPS values Body Temperature Pressure Saturated body conditions For this conver sion the system needs the following data relative hum...

Page 52: ...rs to him or her take the spirette into the mouth with the lips sealing around the spirette taking care not to block its opening with the tongue or bite down excessively on the spirette breathe calmly 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 Fig 3 14 Window showing the ambient conditions ...

Page 53: ... bronchodilator shows effect refer to medication labelling a second spirom etry test is performed 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 The window with the patient s existing tests appears With Fig 3 15 left you display the detailed resu...

Page 54: ...Performing a Test 54 EasyOne Pro EasyOne Pro LAB Fig 3 16 Acquisition screen after three acceptable post trials ...

Page 55: ...n two animations Balloon and Monkey When the animation program is activated we recommend disabling the manual test stop and working with the automatic test stop see General Tab on page 111 The Monkey animation can be viewed in full screen mode Fig 3 17 Balloon animation program for children test start successful test Fig 3 18 Monkey animation program for children test start ...

Page 56: ...sure Saturated body conditions see Ambi ent Conditions on page 51 After three acceptable trials the message Session complete appears Select the patient see Selecting Adding a Patient on page 41 Prepare the patient see Preparations on page 46 and explain the test maneuvers to him or her take the spirette into the mouth with the lips sealing around the spirette taking care not to block its opening w...

Page 57: ...eters b Predicted values c Volume time curve area d Start button e Test information and system interpre tation area f Click for a retrospective test evaluation or to expand the parameter list see Retrospective Test Assessment Enter ing Comments on page 97 g Click to view additional information h Click to perform a new test to view the patient s test list to select a new patient and to print a test...

Page 58: ...ions must be converted to BTPS values Body Temperature Pressure Saturated body conditions see Ambient Conditions on page 51 Select the patient see Selecting Adding a Patient on page 41 Prepare the patient see Preparations on page 46 and explain the test maneuvers to him or her take the spirette into the mouth with the lips sealing around the spirette taking care not to block its opening with the t...

Page 59: ...e curve area d Start button e Test information and system interpre tation area f Click for a retrospective test evaluation or to expand the parameter list see Retrospective Test Assessment Enter ing Comments on page 97 g Click to view additional information h Click to perform a new test to view the patient s test list to select a new patient and to print a test Fig 3 22 Acquisition screen after tw...

Page 60: ...contraindications for the medication used such as 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 The patient should never be left unattended during the tests The following should be available throughout p...

Page 61: ...r patient and attach the nose clip Select Provocation The initial screen is displayed 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 Fig 3 23 Initial screen for bro...

Page 62: ...o 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 Fig 3 24 Screen after three acceptable expiratory FVC measurements a b c d a Toggles between volume time and test diagramm b Current test step c Click to add an FEV1 measurement d Click to display the protocol screen Fig 3 25 Protocol scree...

Page 63: ... next action is Perform repeatable FEV1 measurements Click Start to initiate the FEV1 measurement Note After the FEV1 measurement you need to check whether the measurement quality is sufficient or whether additional trials are required With key a Fig 3 24 you can display the test diagram response curve at any time during the test Click Protocol to display the protocol screen the measurement and th...

Page 64: ...limit the message POSITIVE TEST RESULT will appear the next level 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 27 Protocol screen Fig 3 28 Protocol screen with a positive test result ...

Page 65: ...roto col screen with the post rest results will be displayed Note 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 Fig 3 29 Protocol screen ...

Page 66: ...o predicted values are available because they are calculated on the basis of the patient data In the main menu select Perform Test A menu will appear 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 Fig 3 30 Menu ...

Page 67: ...erform two DLCO tests The pause between the two tests must be at least 4 minutes However do not perform more than five consecutive DLCO tests on one patient ATS ERS Taskforce recommendations literature 11 Literature on page 182 Select the patient see Selecting Adding a Patient on page 41 Attach the nose clip to the patient and explain the test maneuvers to him or her Select DLCO In the BTPS window...

Page 68: ... During exhalation press the Activate button the valve will automatically close at the end of exhalation it is also possible to manually close the valve by pressing the Manual Close button Now instruct the patient to fully inhale the patient is expected to inhale 85 of their vital capacity within 2 to 4 seconds and then hold their breath for 10 seconds wait for the valve to close before breathing ...

Page 69: ...omplete exhalation c Holding breath for 10 seconds d Collection bar its width depends on the selected sampling volume m e Complete exhalation f Keys to expand the curve to check the collection bar for artifacts g Click to show hide more curves mouth pressure flow h Box for comments touch to display the keypad i Click to show and hide control buttons for the collection bar j Click to reset the coll...

Page 70: ...will immediately be calculated and displayed With I j you return the collection bar to its original position 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 ...

Page 71: ...nserting the One Way Valve DLCO barriette FRC barriette and spirette on page 35 Before performing the first FRC test check that the valve unit is properly attached and that the metal coupling ring of the motor is tight Inform patients that they may experience a feeling of dryness during inhalation Also they will hear oxygen escape during the washout phase You can choose between the following tests...

Page 72: ...dal breathing until a stable breathing baseline is detected indicated with a line in the VT diagram representing the breathing baseline line Then perform a full SVC maneuver Lung volume parameters will be calculated based on this linked SVC maneuver data from an external SVC test will not be used Note Perform the SVC maneuver according to ATS ERS guidelines to ensure accurate results Performing a ...

Page 73: ...test the patient should breathe quietly and steadily The respiratory flow should not exceed the displayed range a Fig 3 26 In automatic mode the test starts automatically after the Number of breaths before test start and ends automatically when the measured con centration drops repeatedly below the limit of 2 as configured under FRC mbw Tab on page 122 In manual mode beginning and end of the Washo...

Page 74: ...st online linked a b e c d a Test result b Measuring curve c Volume time curve only shown for linked measurements d Click to enter a comment e Tracer curve logarithmic representa tion see FRC mbw Tab on page 122 f Flow indicator during the washout phase the flow should remain in the green range c f ...

Page 75: ...on of the respiratory tract or patients with a suspected infection of the respiratory tract it is recommended to clean all parts outside of the sensor that were touched during the test before testing a new patient 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 tes...

Page 76: ... click on the appropriate title in the column headers Highlight the test to view Click View Test to view the test Print Preview to view the test before printing it Print to print the test or Trend to view the trend display see Trend View on page 78 Click Patients to display the patient list and click New Test to display the test selection menu Note Alternative Double click on a test to display it ...

Page 77: ...eport layout select c to print the test select the printer select d to change the display scale Fig 3 37 Print preview of the test a b c d a Window showing the currently selected test report b Click to open the layout selection menu c Click to print the displayed report d Click to access a submenu with options for zooming exporting viewing printer selection and additional print functions Fig 3 38 ...

Page 78: ...he views simultaneously presents up to four parameters allowing them to be compared Each parameter has its own vertical axis and scale In the second view a single parameter can be compared with the predicted normals Fig 3 39 Trend view of multiple parameters a b c d a Option buttons for selection of the view b Displayed parameter labels c Click to select a parameter d Icon to initiate the trend pr...

Page 79: ...EasyOne Pro EasyOne Pro LAB 79 Performing a Test Fig 3 40 Trend view of a single parameter and its predicted normals ...

Page 80: ...piratory Flow 50 flow at 50 of expiratory vital capacity FEF 25 75 Mid Expiratory Flow 25 75 flow at 25 to 75 of expiratory vital capacity PEF Peak Expiratory Flow peak expiratory flow PIF Peak Inspiratory Flow peak inspiratory flow VT Tidal Volume Tidal volume at rest ERV Expiratory Reserve Volume expiratory reserve volume IRV Inspiratory Reserve Vol ume inspiratory reserve volume VCmax Maximum V...

Page 81: ... For DLCO the mean values will be displayed in the Result column for the following parameters DLCO VA TLCO DLAdj and TLC IC Inspiratory Capacity inspiratory capacity VT IRV MVV Maximum Voluntary Venti lation maximum ventilation vol ume per minute LLN Lower Limit of Normal lower limit of normal Lung Age lung age see section Pre dicted Values on page 139 8 DLCO CO diffusing capacity ml min mmHg CO d...

Page 82: ...d by FRC at 1 40th of initial tracer concentration 2 N2 see Literature on page 182 16 CEV Cumulative Expired Volume VT Tidal Volume VT kg Tidal Volume kg f Breathing Frequency M0 MR1 MR2 Moment Value and Moment Ratios 1 and 2 from nitrogen washout moment analysis Clinical use of these parameters is limited since the available reference data is based on a small number of pati ents see Literature on...

Page 83: ...ient Click Edit Patient The patient data window will appear Change or add 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 Fig 4 1 Patient data window ...

Page 84: ...A test ends when the volume change during the last 2 seconds is 45 ml or an inspiratory volume 150 ml is detected This end of test criterion slightly differs from the published criterion in 3 which is 25 ml in the last second Reason When the 25 ml in 1 second criterion is applied to the 24 waveforms also defined in 1 and 2 several curves will end too early and these tests might fail We therefore d...

Page 85: ...his or her lungs Test Abrupt End FVC Test only Expiration time less than 2 seconds OR volume during last 0 5 seconds 40 ml when expiration time is 6 seconds OR volume during last second 25 ml when end of test was initiated by an inspiration The patient stopped exhaling too early The patient must exhale still further and force as much air as possible out of his or her lungs Good effort do next Test...

Page 86: ...ssage Criterion Recommended action Rating Criteria A At least 3 acceptable tests for age 6 2 acceptable AND the difference between the best two FEV1 and FVC values is equal to or less than 100 ml 80 ml if FVC 1 0 l for age 6 80 ml or 8 of FVC whichever is greater B At least 3 acceptable tests for age 6 2 acceptable AND the difference between the best two FEV1 and FVC values is equal to or less tha...

Page 87: ...s greatly from previ ous tests The patient can inhale even more deeply and exhale even more air No Steady Tidal breathing detected All end inspiratory volumes of the last 3 breaths within 200 ml Instruct patient to breathe quietly and steadily Maneuver incom plete No ERV and or no IRV could be calculated due an incomplete maneuver session Perform SVC test according to ERS ATS recommendation Do not...

Page 88: ...ly one acceptable trial F No acceptable trial available Message Criterion Recommended action Breath Hold Time out of Range Maneuver not acceptable Breath Hold Time is outside the 8 12 seconds range Breath hold time outside 8 to 12 seconds Exhale immediately when the valve opens Parameter out of Range Test cannot be evalu ated sensor signals do not pass QC check A parameter is out of range e g a ga...

Page 89: ...ks Reference gas measurement and inspiratory gas measurements do not match within 80 ppm This means that most probably there is a leak in the DLCO hose Check for leaks check gas supply Sampling volume at maximum position Test cannot be evalu ated exhaled vol ume too small Can happen when very small vol umes are exhaled Collection bar is beyond rightmost position Activate Automatically rejected vol...

Page 90: ...ptable no sta ble CO signal during breath hold During breath hold CO signal drifts up or down Check spirette und barriette position check connections check DLCO valve unit 3 point calibration failed 1 S factor of the CO sensor outside 0 16 to 0 375 If the error occurs repeatedly then please contact service 3 point calibration failed 2 3 point calibration mixture out side 750 to 1600 ppm CO If the ...

Page 91: ...Test error data error General error in DLCO calculation If the error occurs repeatedly then please contact service DLCO warning High CO sensor drift CO drift during measurement 60 ppm The test result must be interpreted with caution Message Criterion Recommended action ...

Page 92: ...inspiratory time 4 s sample volume 0 1 L Legend VCin as a percentage of VCtarget Inspired volume as a percentage of FVC VC from a previous test If none of these is available the target value is taken from the test itself BHT Breath hold time in seconds Sample Volume Sampling volume for CO and helium measurement also called collection window The sampling volume will be outside this window only unde...

Page 93: ...acer gas molar mass by more than 0 2 g mol This is indicative of air drawn in from outside during inspiration Check FRC barriette are valves jammed or was the FRC barri ette not been properly inserted Check position of spirette and of nose clip Ask patient to breathe calmly FRC MBW Warning In or expiratory pres sure too high Pressure in sensor tube is too high The pressure in the sensor tube excee...

Page 94: ...ume Tidal volume outside 4 to 30 mL kg body weight or outside 0 25 to 0 3 L if the body weight is not sta ted Ask patient to breathe regularly and calmly FRC MBW Error No start of washout detected Multi Breath Washout not found Perform washout procedure cor rectly FRC MBW Error Error in Gas Signal Delay Correction An error occurred during the auto matic determination of the delay between gas signa...

Page 95: ...as connections for leaks Check FRC barriette position FRC MBW Error Error in Alveolar Curve Computation An error occurred during calcula tion of the alveolar gas curve from the first breaths of the washout Check that the test is correctly performed Check position of spirette and of nose clip Contact service FRC MBW Error DLCO Valve Unit NOT mounted on handle sensor Mount valve unit and repeat pro ...

Page 96: ...y grade of D or F indicates inadequate test quality The result must then be interpreted with caution see section Interpretation on page 135 for details 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 b c d a Pre medication test results b Quality grade c System interpretation d Post medicati...

Page 97: ...an 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 3 Click a Fig 5 2 The test assessment icons b appear on the test results screen Follow these steps to make a test acceptable that the system judged unac ceptable Click the icon In the ensuing window select the Acceptable ch...

Page 98: ...ck Set Highest Ranked Fig 5 4 Note To assign ranks 1 2 and 3 please start with rank 3 etc Entering comments Click in the comment area or click 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 4 Changing the trial ranking Fig 5 5 Entering comments ...

Page 99: ...nnect the wall outlet Note When using the wall outlet please observe the hospital s in house instructions and requirements Quit the program with 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 Caution The device will switch off but it remains connected t...

Page 100: ... the temperature and humidity sensor Do not let liquid enter the device To clean the rear panel and the temperature and humidity sensor simply wipe them off with a dry cloth The display is also cleaned with a soft dry cloth In case of major contamination you can use a cloth moistened with alcohol 50 max Wipe the sensor the valve unit the gas supply tube and the power cord down with a cloth moisten...

Page 101: ...ser 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 Preparation on page 20 the filter pack the gas supply tube the one way valve the overpressure valve All parts are included in the Yearly Maintenance Kit 3000 50 50SP see Order Information on page 134 The filter pack at the back of the device consists of the a...

Page 102: ...with and switch off EasyOne Pro with OK see Switching the Device Off on page 99 Open the two screws and take off the cover Grasp the tab of the memory card and remove the card from device Insert the memory card into the backup device When the backup device starts up confirm loading the data from the memory card Data Backup on External Media To prevent loss of data we recommend to backup the data o...

Page 103: ...x and copy the data to a USB flash drive memory stick 3 Software Update Connect the USB flash drive to EasyOne Pro Click Utilities Advanced Enter the password EOPTM or 8005 Click Software Update and double click the update file on the USB flash drive Follow the on screen instructions 4 Check settings Check whether the sensor symbol is displayed 5 Check function Perform a calibration test Utilities...

Page 104: ...ringe Note As an alternative the calibration can be checked with a test subject see Calibration Check with Test Subject on 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 de...

Page 105: ...inted out later If you do not reach 3 accuracy please follow the troubleshooting instruc tions in chapter 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 DLCO Calibration Check The American Thoracic Society ATS recommends checking DLCO calibra tion on a weekly basis or whenever i...

Page 106: ... Hans Rudolph DLCO Simulator 5560 Series Also refer to the DLCO simulator operator manual or to the training clip at www ndd ch As an alternative to checking calibration with a DLCO simulator the calibration can be checked with a test subject see Calibration Check with Test Subject on page 107 Make sure the gas concentrations of the test gas AND the Simulator Test Gas are entered correctly as show...

Page 107: ...led 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 e h d f g b c a Sensor selection b Parameter value tabs c Deselect tests remove check mark d Click to conduct a new test e Click to select ...

Page 108: ...dation Try to blow a QC grade A test Recommendation Perform only one BioCal Check test a day Press Finish Test To show the graphic trend click the Graph button g To select another review parameter change the selection in Displayed Parameter Selection f If you selected a spirometry parameter the spirometry BioCal quality grades will be displayed If you selected a DLCO parameter the DLCO BioCal qual...

Page 109: ...ill be mean precision range upper limit and lower limit The upper and lower limits are 2 SD Standard Deviation Specifications of the BioCal Check QC Grades For each parameter FEV1 FVC FEV6 DLCO VI VA an individual BioCal Check QC grade is calculated Additionally the lowest grade of all parame ters is reported Disposal The product described in this operator manual must not be disposed as unsorted m...

Page 110: ... Configuration general settings Check Calibration measuring accuracy check see Check Measuring Accuracy on page 104 Advanced password protected EOPTM or 8005 installation of software updates data export touch screen calibration Configuration These are the tabs of the configuration menu General Test Device Report Printer EMR Environment Fig 8 1 System settings menu Fig 8 2 Configuration menu Genera...

Page 111: ... practice name will appear on the initial screen and all printed reports a you can add and remove an illustration e g a logo maximum size of the bitmap 260x80 pixels b you open a window with information about the software program c Fig 8 3 Header tab a b c a Fields for entry of the hospital practice name b Click to display an illustration logo c Click to display information about the software prog...

Page 112: ...m to a storage medium c perform a data backup f select a target folder for the current tests g path and name are shown at d Fig 8 4 Storage tab a c f g d b e a Click to create a new database folder b Click to import a database c Click to copy data from to a storage medium d Path and name of the currently used database folder e Click to export a database f Click to perform a data backup g Click to ...

Page 113: ...ou select date and time d you select the language e you select the keyboard layout f you select the width of the scroll bar g you select the volume for the audio signals h Fig 8 5 System Settings tab a c f g d b e h a Click option button to select the units b Select check box to always show the cursor select check box to hear a beep for each key click and select check box to always view all possib...

Page 114: ...this tab you can do the following password protected EOPTM or 8005 map a network drive a disconnect a network drive b enter an IP address c Fig 8 6 Administrator tab a b c a Click to map a network drive b Click to disconnect a network drive c Click to enter an IP address ...

Page 115: ... users are then required to log on with their ID Condition the function is enabled with Enable user handling c Fig 8 7 All tests will be annotated with the user who performed the test The ID of the user who is logged on is shown next to the time Fig 8 7 User Handling tab a b c a Select line to edit logged on users b Select to enter a new user c Select check box to enable disable the function ...

Page 116: ...redicted values for children c Click to select the predicted values for adults d Select deselect the system interpreta tion e Curve selection criteria f Select this check box if you want to stop tests manually g Select the check box to display the ratio parameter as a percentage value h Select the check box to display the per centage deviation from predicted for bronchodilation tests otherwise rem...

Page 117: ...lues for the Best column are selected as follows For the parameters listed below the best value is the highest value from all accepted trials The IC IRV VT and ERV parameters are calculated from the average of all accepted trials For PEF PIF and the volume parameters the best value is the highest value from all accepted trials Ratios such as FEV1 FVC FEF50 VCmax MTC1 are recalculated Other paramet...

Page 118: ... With Parameter Select c you open a window for selection of the parameters to be calculated Different parameters can be selected for the display and for the printout Choose a parameter in the Available list a Click b to transfer it to the Selected list 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 li...

Page 119: ...yOne Pro EasyOne Pro LAB 119 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 a b a b c d c d e e ...

Page 120: ... condition for measurement of the vital capacity after a phase of tidal breathing or directly without an initial tidal breathing phase You also select the parameters for the SVC measurement MVV Tab On this screen you select the parameters for the MVV measurement Fig 8 11 SVC tab Fig 8 12 MVV tab ...

Page 121: ...ange indicated in parentheses b Click to select the predicted values for children c Click to select the predicted values for adults d Select check box to automatically determine the discard volume e Click to select a parameter see Fig 8 10 f Click to update the predicted values e g after selecting another predicted value formula g System dead space h Anatomic dead space i Discarded volume j Select...

Page 122: ...tic termi nation of the test default 2 b After the number of breaths specified at c the test either starts automatically or the Activate button will be dis played for manually starting the test c Minimum number of breaths before the washout phase d Click to select parameters see Fig 8 10 e Choose the tracer curve format f Click to enable disable tests linked with SVC ...

Page 123: ...EasyOne Pro EasyOne Pro LAB 123 System Settings Provocation Tab You select the test protocol from this tab Fig 8 15 Provocation tab ...

Page 124: ... the CO sensor a Additionally you can release the gas pressure c switch the pump on and off b open and close the DLCO valve d Fig 8 16 EasyOne Pro tab a b e c d a Detailed information about the device and the CO sensor b Click to switch the pump manually off and on c Click to release pressure if the gas cylin der has to be exchanged d Click button to open or close the DLCO valve e Click to select ...

Page 125: ...The tab comprises the following sub menus Status Test Configuration General Configuration Report Configuration Consult the EasyOne operator manual for details Selection Tab Select your preferred sensor type on this tab Fig 8 17 EasyOne tab Fig 8 18 Selection tab ...

Page 126: ...on 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 select the files for an XML export d Fig 8 19 Report tab a b d c a Press to display the Report Designer b Press to load report layouts c Press to save export layouts d Press to select the data for an XML export ...

Page 127: ... Printer Tab 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 b c a Press to open the printer list b Press to update the printer list c Select the default printer ...

Page 128: ...ettings see GDT Interface on page 140 This tab also allows you perform a new installation of the program e Fig 8 21 EMR tab a b c e d a Enter the GDT ID b Select the EMR system from the list c Select the character set from the list d Press button to search for the GDT folder e Click to install a new EMR system ...

Page 129: ...he examination site b Measured values for room tempera ture relative humidity altitude above sea level and case temperature c BTPS conversion factor d ATPS values will be used yes no no BTPS conversion e Select the check box if you do not want to enter ambient conditions for two hours or until a restart Otherwise remove the check mark by clicking again f The values entered at a will be used for BT...

Page 130: ...our ndd dealer When you start a test you see the message Check spirette insertion The spirette is not correctly positioned Ensure that the trian gle on the spirometer is lined up with the tri angle on the spirette Calibration check outside 3 5 The spirette is not correctly positioned Insert the spirette as described in section InsertingtheOne Way Valve DLCO barri ette FRC barriette and spirette on...

Page 131: ...Measuring range volume 12 l Measuring range flow 16 l s Resistance 1 5 cm H2O l s at 12 l s Molar mass analyzer Type ultrasonic transit time Measuring range 9 to 50 g mol Accuracy 0 02 g mol Resolution 0 01 g mol Carbon mon oxide analyzer Type NDIR Measuring range 0 to 0 35 Accuracy 0 001 Resolution 0 0001 CO2 analyzer LAB only Type nondispersive infrared Measuring range 0 to 15 Resolution 0 005 A...

Page 132: ... Ayers Burrows Crapo Goldman Becklake Knud son McGrath Thompson Miller Gutierrez Canada Klement Russia NHANES Polgar ERS Zapletal Roca Hedenström Gulsvik Pereira 2008 Thompson see Predicted Values on page 139 Operating conditions Temperature 5 to 40 C 41 to 104 F LAB 10 to 40 C 50 to 104 F Relative humidity 15 to 95 no condensation LAB 30 to 75 no condensation Atmospheric pressure 700 to 1060 hPa ...

Page 133: ...EasyOne Pro EasyOne Pro LAB 133 Specifications Power con sumption max 80 VA Life time 7 years ...

Page 134: ...for EasyOne Pro LAB only 3000 60 1 Stand 3000 60 2 Carry bag 3000 50 1SP Filter pack 3000 50 2SP Motor block 3000 50 3SP DLCO valve 3000 50 4SP Pressure tube DLCO 3100 50 8SP Pressure tube FRC for EasyOne Pro LAB only 3000 50 4 1SP Quick Connect fitting for gas pressure regulator 3000 50 5SP Flow sensor 3000 50 6SP Touch stylus 3000 50 7SP Temperature sensor 3000 50 8SP Gas supply tube 3000 50 9SP...

Page 135: ...atic 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 ...

Page 136: ... If the selected predicted value publication does not define a lower limit of normal LLN LLN is calculated as predicted value 1 645 x RSD residual standard deviation If RSD is not defined the LLN for FEV1 FVC is set at 90 of the predicted value the LLN for FEV1 at 80 of the predicted value and the LLN for FVC at 80 of the predic ted value 4 If the quality grade is D and the results are within the ...

Page 137: ...terpretation COPD Management of chronic obstructive pulmonary disease in adults in primary and secondary care 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 ...

Page 138: ...Appendix 138 EasyOne Pro EasyOne Pro LAB Fig 12 1 ...

Page 139: ...etation No interpretation not enough acceptable maneuvers Normal Spirometry Normal Spirometry Mild Obstruction Mild Obstruction Moderate Obstruction Moderate Obstruction Severe Obstruction Severe Obstruction Very Severe Obstruction Very Severe Obstruction Possible Restriction Restriction probable further examinations recom mended Normal Spirometry At COPD risk Normal Spirometry at COPD risk No pre...

Page 140: ...ware Settings The following settings need to be made in the Configuration menu Parameter Description GDT Folder The GDT folder of the EMR system This may also be a folder in a network drive For convenient path entry the Browse button may be used The GDT file will be written to this folder and read in from this folder Computer Name Name of the EMR computer Export single mea surement value If this c...

Page 141: ...o Software When the EMR interface is used for the first time the following settings have to be made Start EasyOne Pro Open the menu Utilities Configuration EMR Enter the path of the EMR folder according to the export path set in EMR TurboMed in the above example c nddmed Enter the EMR computer name as TurboMed Confirm the dialog with OK Close EasyOne Pro Field Entry Description Name EasyOne Pro Na...

Page 142: ... required Finish EMR sends data to EMR and closes EasyOne Pro TurboMed now receives the data Confirm with OK Close the program now with Ende 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 GDT Field ID Description Comment 80...

Page 143: ...8315Extern 0128316PCS 014921802 00 01030001 0093100 0143101Meier 0163102Manfred 017310301011966 0093104 019310624106 Kiel 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 3622 Height in cm 3623 Weight in kg ...

Page 144: ...ent name ID test date and test time Example forced expiratory spirometry Here the example transmission GDT Export with a forced loop test FVL The data marked grey will be exported only when the Export single measure ment value check box is selected 01380006310 014810001385 0128315EDV 0128316NDD 014921802 00 01230006 0 0183101Appeldorn 0173102Heinrich 017310323101945 01031101 0123622178 011362366 0...

Page 145: ...6580643340000 0348470Predicted Set NHANES III 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 01484...

Page 146: ...nt have to be inver ted e g factor is multiplied instead of divided If compared to the original formulas in the ERS ATS statement the following formulas are therefore inverted multiplication instead of division and vice versa Adjustment for hemoglobin The following formula is applied to correct for hemoglobin Male adults age 15 DLadj DLCO 1 7 Hb 10 22 Hb Hb in g dl Female and children age 15 DLadj...

Page 147: ... in mmHg PIO2 Pamb 47 0 20942 Pamb and PH2O in mm Hg Unit conversion P mm Hg P mbar 0 750 Pressure at altitude Pamb in mm Hg h in m Allowed range for P 100 to 750 mm Hg Adjustment for COHb concentration and CO back pressure Adjustment for carboxyhaemoglobin is performed as follows DLadj DLCO 102 CO Hb CO Hb in Allowed range for CO Hb 0 bis 100 Default value 2 at this value DLadj equals DCLO Exampl...

Page 148: ...h FEV1 FVC 70 TLCsb is a systematically underesti mated and showed poor correlation to TLCwash r 0 67 0 94 After using the simple correction equation they showed that in patients with FEV1 FVC 70 range 40 70 had an acceptable correlation between TLCsb and TLCwash r 0 83 0 94 p 0 05 The software labels of all Punjabi corrected values if any with Cor e g TLC Cor This means that in patients with FEV1...

Page 149: ...ed single breath TLCsb is below the lower limit of normal there is a risk of incorrectly concluding a Restriction or a Mixed Defect Obstruction AND Restriction when none is actually pres ent 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 ...

Page 150: ...t Configuration In the Configuration menu select the Report tab On the Report tab select the Layout Editor Adding a Logo to an Existing Test On the Report Designer tab select New Report Fig 12 3 left Select the test to which you want to add the logo Fig 12 3 right Fig 12 2 Report tab Fig 12 3 New Report button left test selection right ...

Page 151: ...EasyOne Pro EasyOne Pro LAB 151 Appendix Select the Picture Box Fig 12 4 Insert the frame in the appropriate position Fig 12 5 Fig 12 4 Picture Box button Fig 12 5 Positioning the frame ...

Page 152: ...6 The logo will appear in the frame Save the test under a new name Configuring the Graphic Representation of an Existing Test Select the test via New Report or Open Select Windows and then Report Explorer Fig 12 8 Select Detail Report Graph Fig 12 8 Click graphVT1 Fig 12 6 Image button Fig 12 7 New Report Open buttons ...

Page 153: ... Spiro Graph Configuration window will be dis played Fig 12 10 Select Test Type Choose options in the Trial Selection pane Choose options in the Appearance pane Close the window with OK Save the test under a new name Fig 12 8 Windows Report Explorer Detail Report Graph buttons Fig 12 9 Detail Report Graph window Fig 12 10 Spiro Graph Configuration window ...

Page 154: ...al operation in the configuration in which it is being used 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 Compliance Electromagnetic Environment Guidance RF emissions to EN 55...

Page 155: ...st 30 Electrical fast transient burst to EN 61000 4 4 2 kV for power sup ply lines 1 kV for input out put lines the product has no power cords or input output lines Surge to EN 61000 4 5 1 kV differential mode 2 kV common mode the product has no power cords Voltage dips short interrup tions and volt agevariationson power supply input lines to EN 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60...

Page 156: ...separation dis tance calculated from the equation applicable to the fre quency of the transmitter Recommended separation dis tance d 1 2 d 1 2 for 80 MHz to 800 MHz d 2 3 for 800 MHz to 2 5 GHz where P is the maximum out put power rating of the trans mitter in watts W according to the transmitter manufac turer and d is the recom mended separation distance in meters m Field strengths from fixed RF ...

Page 157: ... which radi ated 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 as recommended below according to the maximum output power of the communica tions equipment rated maxi mum output power of transmit ter W separatio...

Page 158: ...nd 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 The software on this device includes software licensed from Microsoft Cor poration or its affiliate The terms also apply to any Microsoft Updates Supplements Internet based services and Support services for this software unle...

Page 159: ...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 soft ware running on a server Device Connections You may use terminal services protocols to connect the device to another device running business task or processes software such as email word processing scheduling o...

Page 160: ...Feature If the ndd Medizintechnik AG enabled the device Remote Boot feature of the software you may use the 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 and use the Remote Boot Installation Service only for deployment of the software to devices as part of the Remo...

Page 161: ...ate only when you use the Internet 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 Compatible online music services in your region New versions of the player and Codecs if your device does not have the correct ones for...

Page 162: ...city 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 You should keep the label on the device or packaging to prove that you are licensed to use the software To identify genuine Microsoft software see http www...

Page 163: ... software services content including code on third party internet sites or third party programs and Claims for breach of contract breach of warranty guarantee or condition strict liability negligence or other tort to the extent permitted by applicable law It also applies even if Microsoft should have been aware of the possi bility of the damages The above limitation may not apply to you because yo...

Page 164: ...rt up and Initial Preparation on page 20 Performing a Test on page 41 System Settings on page 110 Index on page 185 Click to select a patient or add a new patient Click to perform a test Click to review the results from previous tests Selected patient Click to quit the program Click to modify the sys tem settings Sensor connected indi cator Help button ...

Page 165: ...nt selec tion Filter Last Name by entering one or more letters you limit the number of patients to those meeting the filter criteria Click to display the menu options Click to add a new patient Click to clear the filter criterion Click to perform a test with the selected patient Click to view all the patient s tests Click to edit the patient data Sensor connected indicator Help button Click to del...

Page 166: ...page 45 Index on page 185 Press the TAB or Enter key after each entry Click to close the win dow saving the data Click to select the gender Click to generate an automatic patient ID Click to select the ethnic origin Click to close the window without saving the data Sensor connected indicator Help button Click to display the menu options Click to open other tabs ...

Page 167: ...efer to Selecting a Test on page 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 Test selection Selected patient Back to main menu Sensor connected indi cator Help button Click to view patient data ...

Page 168: ...on page 51 Components and Functional Description of EasyOne Pro on page 16 Index on page 185 Ambient conditions Selected patient Back to main menu Sensor connected indi cator Help button Click to view patient data Click to recalculate BTPS Click to close the window without saving the data Click to close the window saving the data ...

Page 169: ...y Grades on page 84 Connecting the Printer on page 31 Index on page 185 Click column header to sort the list Selected patient Click to display the menu options Helpbutton Click to view patient data Test with Post test data Click to view the test Click to print the test Click to view trend information Click to conduct a new test Click to view the patient list ...

Page 170: ... page 84 Connecting the Printer on page 31 Index on page 185 Click to select the displayed curve Selected patient Back to main menu Sensor connected indi cator Help button Click to view patient data Predicted values Click to view the test Click to select the scale Click to conduct a new test Click to select a new patient Click to view the test list Click to enter a test evaluation ...

Page 171: ...ing the Printer on page 31 Index on page 185 Complete exhalation Selected patient Back to main menu Sensor connected indicator Help button Click to view patient data Tidal breath ing Click to enter a test evaluation Holding breath for 10 seconds Complete exhalation Click to show more curves Click to show hide the keypad Click to display the collection bar con trol buttons Click to change the scale...

Page 172: ...ality Grades on page 84 Connecting the Printer on page 31 Index on page 185 Measurement curve Selected patient Back to main menu Sensor con nected indicator Help button Click to view patient data Volume time curve only for linked tests Click to enter a test evalu ation Click to enter a comment Click to show hide the keypad Tracer curve Click to recalculate the curve ...

Page 173: ...5 System Settings on page 110 Quality Messages and Quality Grades on page 84 Connecting the Printer on page 31 Index on page 185 Protocol steps Selected patient Back to main menu Help Click to view patient data Protocol Test result Next step to complete Sensor connected indicator Measuredvalues in tabular form Test diagram ...

Page 174: ...Quality Grades on page 84 Connecting the Printer on page 31 Index on page 185 Selected patient Sensor connected indicator Click to view patient data Selected test report Click to select other report layouts Click to print the report Click to display a submenu with zoom export viewing and print functions Back to main menu Help button Click to show hide the keypad ...

Page 175: ... on page 78 Switching the Device Off on page 99 Index on page 185 Selected patient Sensor connected indi cator Help button Click to view patient data Option buttons for selection of the view Click to select a parameter Displayed parameter labels Icon to initiate the trend printout ...

Page 176: ...p button Click to view patient data Click to export data Click to display the configuration menu Click to perform the calibration check Click to install software updates Back to main menu Click to display the lower group of control buttons password protected Click to cali brate the touch screen Click to per form a data backup Remote support Selected patient XML Export ...

Page 177: ... page 110 Index on page 185 Selected patient Sensor connected indicator Help button Click to view patient data Text boxes for entry of the header texts Click to search for an illustration to be added Click to open more tabs Back to main menu Click to view information about the software program ...

Page 178: ...Pro Flow Sensor Design and Operation on page 17 Specifications on page 131 Index on page 185 Selected patient Sensor con nected indicator Help button Click to view patient data Calibration check with syringe Back to main menu Calibration check with test subject DLCO simulator check Click to show hide the keypad ...

Page 179: ...7 Specifications on page 131 Index on page 185 Selected patient Click to display the graphic trends Help button Click to view patient data Select the sensor Back to main menu Click to select the BioCal Subject Click to add a new BioCal Subject Click to select the parameter for display Click to conduct a new test Click to display the refer ence control values Deselect a test remove check mark ...

Page 180: ...lution number is assigned to each breath k is defined as the ratio of Cumulated Expired Volume CEV at the end of any breath k to FRC End tidal nitrogen concentrations are normalized and plotted versus dilution number for each breath and this distribution is used for Moment Analysis The normalized nitrogen concentration Ak is calculated as Ck C0 where Ck is end tidal nitro gen concentration at the ...

Page 181: ... the sum of weighted area segments The tail of the curve is given more weight for successively higher Moments LCI and Moment ratios are both related to the number of volume turnovers LCI is a static value of the number of volume turnovers needed to reduce end tidal nitrogen concentration to 2 while the latter is a dynamic mea sure of MBNW Moment analysis has been described by several authors see L...

Page 182: ...aven Philadelphia 1997 8 American Thoracic Society Lung Function Testing Selection of Refer ence Values and Interpretative Strategies Am Rev Respir Dis 1991 144 1202 1218 9 Morris JF Temple W Short Report Spirometric Lung Age Estima tion for Motivating Smoking Cessation Preventive Medicine 14 655 662 1985 10 Polgar Promadhat Pulmonary Function Testing in Children Tech niques and Standards W B Saun...

Page 183: ...diatr Pulmonol 1998 25 1 52 58 18 P Aurora W Kozlowska J Stocks Gas mixing efficiency from birth to adulthood measured by multiple breath washout Respiratory Physi ology Neurobiology 148 125 139 2005 19 AA Hutchinson AC Sum TA Demis A Erben LI Landau Moment Analysis of Multiple Breath Nitrogen Washout in Children Am Rev Repir Dis 125 28 32 1982 20 R Kraemer B Meister Fast real time moment ratio an...

Page 184: ...Appendix 184 EasyOne Pro EasyOne Pro LAB ...

Page 185: ...eate 112 Date format select 113 Date set 113 Definition of the parameters 80 Device tab 124 Device preparation 23 Disposal 109 DLCO acceptability and quality grades92 DLCO barriette 35 DLCO Calibration check 105 DLCO gas supply 26 DLCO measurements adjustment 146 DLCO quality messages and grades 88 DLCO tab 121 DLCO test 67 DLCO test gas requirements 18 DLCO test contraindications 15 E EasyOne Pro...

Page 186: ...3 NICE Interpretation 137 Nitrogen washout 71 NLHEP Interpretation 136 O Order Information 134 P Parameter definitions 99 Parameter select 118 Parameters definition 80 Patient data edit 83 Patient selection 41 42 Post test 53 Power 33 Predicted values 139 Pre test 53 Printer driver select 127 Printer tab 127 Printer connect 31 Provocation tab 123 Q Quality grade 50 Quality grades 84 Quality messag...

Page 187: ... 75 Test print 75 Test retrieve 75 Time set 113 Touch screen 39 Touch screen calibrate 103 Transport damage 20 Trend view 78 Troubleshooting 130 U Units select 113 Update of the software 103 USB ports 22 User Handling tab 115 V Volume 113 W Warning definition 8 Warranty 7 Y Yearly Maintenance Kit 101 ...

Page 188: ...ndd Medical Technologies Two Dundee Park Andover MA 01810 USA www nddmed com ndd Medizintechnik AG Technoparkstr 1 CH 8005 Zürich Switzerland www ndd ch ...

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