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EasyOne Pro™ / EasyOne Pro™ LAB

5

Introduction

1

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.



The flow sensor has been assigned to class IIa as specified in Annex IX of
the Directive 93/42/EEC.



The device fulfills the requirements of standard EN 60601-1 "Medical
electrical equipment, Part 1: General requirements for basic safety and
essential performance" as well as the electromagnetic immunity
requirements of standard EN 60601-1-2 "Electromagnetic compatibility
– Medical electrical equipment".



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
relevant EMC requirements. X-ray equipment, MRI devices, radio
systems, and cellular telephones are possible sources of interference as
they may emit higher levels of electromagnetic radiation. Keep the
equipment away from these devices and verify its performance before
use.



The device is suitable for continuous operation.



The product fulfills the requiremens of the following standards:



EN ISO 14971



IEC60601-1: 2005



EN 60601-1: 2006



EN 60601-1-2: 2007



EN 60601-1-6: 2007



The country of manufacture is indicated on the device label.

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Содержание EasyOne Pro

Страница 1: ...Version V03C EasyOne Pro EasyOne Pro LAB Operator s Manual ...

Страница 2: ...o 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 Medizintechnik...

Страница 3: ...Gas Supply 25 2 5 Connecting the Keyboard and the Mouse 30 2 6 Connecting the Printer 30 2 7 Power 32 2 8 Inserting the One Way Valve DLCO barriette FRC barriette and spirette 33 2 9 Switching the Device On Functional Test 37 3 Performing a Test 40 3 1 Selecting Adding a Patient 40 3 2 Selecting a Test 44 3 3 Forced Vital Capacity FVC FVL 45 3 4 Vital Capacity SVC 55 3 5 Maximum Voluntary Ventilat...

Страница 4: ... Specifications 117 11 Order Information 119 12 Appendix 120 12 1 Interpretation 120 12 2 Predicted Values 123 12 3 GDT Interface 124 12 4 Introduction to Adjustment of DLCO Measurements 130 12 5 How to interpret TLC from a single breath maneuver 132 12 6 Report Designer 134 12 7 Electromagnetic Compatibility EMC 138 12 8 Microsoft Software License Terms for Windows XP Embedded Runtime 143 12 9 Qu...

Страница 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...

Страница 6: ... 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 that information p...

Страница 7: ...ndd if you intend to connect equipment not mentioned in this manual Components 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 11: ...ing the applicable waste control regulations Keep the packaging material out of children s reach 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 ...

Страница 12: ...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 ...

Страница 13: ...he 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 manufacture in the YYYY MM format Manufacturer Type BF applied par...

Страница 14: ... a DLCO test 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 Residual 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 ...

Страница 15: ...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...

Страница 16: ...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...

Страница 17: ...mixture 10 helium accuracy 10 0 3 carbon monoxide accuracy 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 ndd dealer Equipment not intended for mobile use can also be used with large gas cylinders Use only the supplied original tubing to connect the gas c...

Страница 18: ...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...

Страница 19: ...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 89 Ambient Conditions Excessive amounts of dust lint and miscellaneous clutter around the instrument could result in malfunctions due to internal tubing blockages overhea...

Страница 20: ...0 EasyOne Pro EasyOne Pro LAB 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 sensor d ON OFF switch e Touch stylus f Sensor see Fig 2 3 ...

Страница 21: ... Backup on Memory Card on page 91 i LAN ports printer j Monitor k Serial RS232 ports l Connection for temperature and humidity sensor m Connection for tube from DLCO gas cylinder 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 ...

Страница 22: ...ing 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 barriette w Motor block release button x spirette Fig 2 4 Connecting the sensor cable ...

Страница 23: ...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 ...

Страница 24: ...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 position 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 the...

Страница 25: ...e 17 The 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 ndd dealer Equipment not intended for mobile use can also be ...

Страница 26: ...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...

Страница 27: ...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 ...

Страница 28: ...inders 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 liable for any damage Close the main valve whenever the gas cylinder is not in use Check that the main valve a and the pressure relief valve c are closed Fig 2 12 Gas...

Страница 29: ...e tube end shows signs of mechanical damage grooves cut off the damaged portion Connect the other end of the tube to the pressure relief valve c Open the main valve a of the gas cylinder completely Slowly open the pressure relief valve c and set the manometer d to a secondary pressure of 3 bar Danger Explosion Hazard An FRC overpressure valve that opens at 5 bar is integrated in the device If you ...

Страница 30: ... on the printer used connect it to one of the USB ports g Fig 2 2 or to one of the LAN ports i Note Preinstalled and compatible printer models please contact your ndd dealer to find out about other options HP Deskjet 6988 HP Deskjet 6940 HP Officejet H470 HP Universal Printing PCL5 see below In the main menu select Utilities Configuration Printer Open the printer list and select the printer Printi...

Страница 31: ...Start up and Initial Preparation Select the test to print Press Print the printer window will appear Select Search for Network printers Select the printer to use Fig 2 15 Test selection Fig 2 16 Printer window Fig 2 17 Printer window ...

Страница 32: ...death and severe damage to the equipment and interconnected equipment Grounding reliability and leakage current suppression can only be assured when the power connectors are properly connected 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 ...

Страница 33: ...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 is intended for single patient use Use a new one for each patient to prevent cross contamination between patients Fig 2 18 Mains connection a c b a Potential equalization pin b Mains connector c Mai...

Страница 34: ...to the valve unit aligning the arrows as shown in Fig 2 19 and turn it clockwise as far as possible Insert the DLCO barriette in the one way valve aligning the arrows as shown in Fig 2 20 and check that it sits tight Fig 2 19 Attaching the one way valve Fig 2 20 Inserting the DLCO barriette ...

Страница 35: ... 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 between patients Fig 2 21 Inserting the FRC barriette ...

Страница 36: ... you 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...

Страница 37: ...ust 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 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 23 Powe...

Страница 38: ...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 100 for details about entering the data c Click to select a patient or add a new patient...

Страница 39: ...yOne Pro EasyOne Pro LAB 39 Start up and Initial Preparation Select Utilities Configuration Test DLCO Compare the displayed values with the data on the gas cylinder Close the tab with OK Fig 2 25 DLCO tab ...

Страница 40: ...an automatically assigned ID e g Q_0033 see Quick Test on page 59 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 t...

Страница 41: ...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 ...

Страница 42: ...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 ...

Страница 43: ... 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 ...

Страница 44: ...erform Test Note If the unit selected is EasyOne see Device Tab on page 111 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 112 for configuration options Fig 3 6 Test selection screen Fig 3 7 Selection screen when the selected device ...

Страница 45: ...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 ...

Страница 46: ...g out until the lungs are completely empty breathe in again 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 expl...

Страница 47: ...t 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 105 the operator must terminate the measurement by clicking the Test End button or by pressing ...

Страница 48: ...e to inform you as to whether the maneuver was acceptable or not see System Interpretation on page 82 This function also allows the physician to improve patient instructions Fig 3 10 Acceptable FVC test a a b e f g c d a Predicted values b Test results c Area for review comments d Click to perform a post test see Bronchodilation Post Tests on page 52 e Test information system interpretation f Clic...

Страница 49: ...rial for each subsequent spirometry maneuver A review comment can be entered in area c or the results can be edited do not forget to give the reviewer s name When three acceptable tests have been performed the message Session complete appears and a quality grade from A optimal to F a is displayed Note If FEV6 is selected instead of FVC the measurement will stop automatically after 6 seconds Fig 3 ...

Страница 50: ...d in color all other parameters are grey Adding a Spirometry Trial If you would like to add trials to a previous test e g if the patient needed a break or if other patients were tested in between please proceed as follows Remember however that it is only possible to add a trial to a previous test that was performed on the same day Select the patient Click Perform Test Select the test e g FVC A men...

Страница 51: ...eck the data For the pending test you can now edit the data if necessary or confirm them if they are correct Edit the values if necessary and click Confirm to close the window Warning Erroneous Measurement Results Incorrect entries may lead to erroneous test readings and incorrect system interpretations The specified measuring accuracy is ensured only when all entries are correct Fig 3 14 Window s...

Страница 52: ...the tests as described in section Measurement on page 47 Note The volume time curve Fig 3 16 does not display the forced inspiration at the end of the maneuver Bronchodilation Post Tests The Post test is usually performed to determine the patient s response to bronchodilating asthma medication This is done by administering a bronchodilator to the patient after he or she has performed a spirometry ...

Страница 53: ...s Fig 3 15 right Conduct the tests as described in section Measurement on page 47 As soon as three acceptable trials have been performed the message Session complete appears and a quality grade from A optimal to F is displayed see Quality Messages and Quality Grades on page 72 Fig 3 15 Detailed test results Fig 3 16 Acquisition screen after three acceptable post trials ...

Страница 54: ...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 100 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 ...

Страница 55: ...sure Saturated body conditions see Ambient Conditions on page 51 After three acceptable trials the message Session complete appears Select the patient see Selecting Adding a Patient on page 40 Prepare the patient see Preparations on page 45 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 wi...

Страница 56: ...meters b Predicted values c Volume time curve area d Start button e Test information and system interpretation area f Click for a retrospective test evaluation or to expand the parameter list see Retrospective Test Assessment Entering Comments on page 82 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 ...

Страница 57: ...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 40 Prepare the patient see Preparations on page 45 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...

Страница 58: ...me curve area d Start button e Test information and system interpretation area f Click for a retrospective test evaluation or to expand the parameter list see Retrospective Test Assessment Entering Comments on page 82 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 two...

Страница 59: ...the DLCO test the valve unit must be attached to the sensor see Fig 2 7 Furthermore a new barriette and in case of a new patient a new spirette must be inserted see Inserting the One Way Valve DLCO barriette FRC barriette and spirette on page 33 Before performing the first DLCO test check that the valve unit is properly attached and that the metal coupling ring of the motor is tight Before perform...

Страница 60: ...ut taking the spirette into the mouth yet Fig 3 24 shows the patient during a test using the sensor stand optional accessory 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 take the sensor into the mouth with the...

Страница 61: ...e 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 After the 10 seconds the valve opens and the patient is required to exhale quickly but avoiding forced breathing and continue tidal breathing until the test stops After a successful test the message Good effort w...

Страница 62: ...conds 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 collection bar k Click to move the collection bar...

Страница 63: ...n bar to the right The resulting new values 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 ...

Страница 64: ... of dryness during inhalation Also they will hear oxygen escape during the washout phase There is a manual mode and an automatic mode see FRC mbw Tab on page 110 The patient wears a nose clip during the measurement and the lips must seal around the mouthpiece to prevent ambient air from being inhaled Attach the FRC barriette see FRC Test EasyOne Pro LAB only on page 64 Select the patient see Selec...

Страница 65: ...d of the Washout phase must be manu ally determined After a successful test the message Good effort will be displayed Fig 3 26 FRC Test a b c e d a Tidal breathing b Measuring curve c Test results d Enter comment e Tracer curve logarithmic representation see FRC mbw Tab on page 110 ...

Страница 66: ...n 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 89 3 10 Retrieving Printing Stored Tests EasyOne Pro saves all tests Old measurements can be called up at any time to perform a new test ...

Страница 67: ... test date comment To do so 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 69 Click Patients to display the patient list and click New Test to display the test selection menu Fig 3 27 Retrieving printin...

Страница 68: ... of the test select b to display the test report menu report layout select c to print the test select the printer select d to change the display scale Fig 3 29 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 pri...

Страница 69: ...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 30 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...

Страница 70: ...Performing a Test 70 EasyOne Pro EasyOne Pro LAB Fig 3 31 Trend view of a single parameter and its predicted normals ...

Страница 71: ...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 ...

Страница 72: ...arks The main articles 2 and 3 do not numerically define the minimum expiratory peak flow time PEFT that is required for an acceptable test In this case 160 ms is used The end of test criteria for FVC tests are 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 This end of test criterion slightly differs from the published c...

Страница 73: ... 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 meets above criteria Good trial Only one to two more good trials and the test is complete Do not start too early The time to peak flow PEFT is le...

Страница 74: ... 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 than 150 ml 100 ml if FVC 1 0 l for age 6 100 ml or 10 of FVC whichever is greater C At least 2 acceptable tests AND the difference between the best tw...

Страница 75: ...rs greatly from previous 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 incomplete No ERV and or no IRV could be calculated due an incomplete maneuver session Perform SVC test according to ERS ATS recommendation Do not ...

Страница 76: ...nly 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 evaluated sensor signals do not pass QC check A parameter is out of range e g a ga...

Страница 77: ... pass QC check possibly due to leaks 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 evaluated exhaled volume too small Can happen when very small volumes are exhaled Collection bar is beyond rightmost position Exha...

Страница 78: ...aluated gas signals do not pass QC check automatic delay correction failed Automatic time delay correction failed Repeat test correctly End Insp Exp Test cannot be evaluated no tidal breathing detected prior to DLCO maneuver No tidal breathing has been detected before the test Repeat test correctly CO Insp Drift Maneuver not acceptable no sta ble CO signal during breath hold During breath hold CO ...

Страница 79: ...ple Volume Sampling volume for CO and helium measurement also called collection window The sampling volume will be outside this window only under special circumstances e g for very small VCs 4 DLCO variability as a percentage and in absolute values 5 Inspiratory time in seconds 6 Number of accepted trials In order to be acceptable a trial must meet the following criteria VI 85 of VCtarget Breath h...

Страница 80: ...roperly 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 exceeds 5 mbar possible rea sons are 1 Insufficient pressure at the O2 gas port 2 Patient s breaths are too deep the respiratory resistance and thus the pressure drop increase from about 2 ...

Страница 81: ...required for calculation of FRC was not reached FRC test was stopped prematurely FRC MBW Error Error in Tracer Gas Concentration The molar mass change caused by the tracer gas does not corres pond to the theoretical values Check whether O2 is used Check gas connections for leaks Check FRC barriette position FRC MBW Error Error in Alveolar Curve Computation An error occurred during calcula tion of ...

Страница 82: ...you see message Session Complete after performing a test 5 6 Retrospective Test Assessment Entering Comments Note You must be logged in as a user to be able to enter a test assessment and comments Changing the Trial Acceptability The trial acceptability and ranking of tests can be changed retrospectively This means that you can make tests unacceptable that the system judged acceptable and vice ver...

Страница 83: ...w these steps to make a test acceptable that the system judged unacceptable Click the icon In the ensuing window select the Acceptable check box To assign the highest rank to a test click the icon and in the ensuing window click Set Highest Ranked Fig 5 4 Fig 5 2 Changing the trial acceptability a b Fig 5 3 Changing the trial ranking ...

Страница 84: ...nd 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 ...

Страница 85: ...0 MEF 50 Mid Expiratory 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 Volume inspiratory reserve volume V...

Страница 86: ...e LLN Lower Limit of Normal lower limit of normal Lung Age lung age see section Predicted Values on page 123 8 DLCO CO diffusing capacity ml min mmHg CO diffusing capacity ml min mmHg TLCO CO diffusing capacity mmol min kPa CO diffusing capacity mmol min kPa DLadj Diffusing capacity adjusted Hb PaO2 COhb altitude adjusted diffusing capacity VA Alveolar volume BTPS alveolar volume BTPS DLCO VA Krog...

Страница 87: ...xpired 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 165 17 to 21 for a detailed descrip tion please refer to chapter Easy One Pro LAB Washout Moment...

Страница 88: ...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...

Страница 89: ...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 moistene...

Страница 90: ...ly 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 Preparation on page 19 the gas supply tube the one way valve Every three years The filter pack at the back of the device must be replaced every three years It consists of the air inlet with filter and a Nafion tube to d...

Страница 91: ...ith and switch off EasyOne Pro with OK see Switching the Device Off on page 88 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 on...

Страница 92: ...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...

Страница 93: ...Syringe Note As an alternative the calibration can be checked with a test subject see Calibration Check with Test Subject on page 96 The EasyOne Pro calibration can be checked with a syringe using the calibration check function The American Thoracic Society ATS recommends that the spirometer calibration be checked on a regular basis Owing to the ultrasound technology used in the flow sensor the de...

Страница 94: ...printed out later If you do not reach 3 accuracy please follow the troubleshooting instructions in chapter Troubleshooting Tips on page 116 Should you not be able to remedy the defect by following these instructions either please consult ndd or one of their representatives DLCO Calibration Check The American Thoracic Society ATS recommends checking DLCO calibration on a weekly basis or whenever ir...

Страница 95: ... 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 96 Make sure the gas concentrations of the test gas AND the Simulator Test Gas are entered correctly as shown...

Страница 96: ...ed 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 t...

Страница 97: ...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...

Страница 98: ...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 parameters is reported Disposal The product described in this operator manual must not be disposed as unsorted mu...

Страница 99: ... Configuration general settings Check Calibration measuring accuracy check see Check Measuring Accuracy on page 93 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 General...

Страница 100: ... 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...

Страница 101: ...ta from to a storage medium c perform a data backup e Select a target folder for the current tests f path and name are shown at d Fig 8 4 Storage tab a c e f d b 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 perform a data backup f Click to select the database folde...

Страница 102: ...e program will prompt you for the patient s age or date of birth g you select the width of the scroll bar h you select the volume for the audio signals i Fig 8 5 System Settings tab a c f h d b e i g a Click option button to select the units b Select check box to always show the cursor or deselect select check box to hear a beep for each key click or deselect c Click to select the regional setting...

Страница 103: ...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 ...

Страница 104: ... 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 ...

Страница 105: ...n buttons to select the value Best Value Best Trial b Click to select the predicted values for children c Click to select the predicted values for adults d Select deselect the system interpretation 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 pe...

Страница 106: ...e 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 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 FVC FVL Tab Fig 8 9 ...

Страница 107: ...played parameter readings 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...

Страница 108: ... 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 ...

Страница 109: ...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...

Страница 110: ...oncentration for automatic 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 displayed 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 ...

Страница 111: ...d 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 15 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 cylinder has to be exchanged d Click button to open or close the DLCO valve e Click to select ...

Страница 112: ...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 16 EasyOne tab Fig 8 17 Selection tab ...

Страница 113: ...lication Note EasyOne Pro import Layout save layouts Export layout Printer Tab After connection of the printer you select the printer driver on this tab see Connecting the Printer on page 30 EMR Tab Here you select the EMR system and the corresponding settings see GDT Interface on page 124 Fig 8 18 Printer tab a b c a Press to open the printer list b Press to update the printer list c Select the d...

Страница 114: ...ne Pro EasyOne Pro LAB Fig 8 19 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 PCS system ...

Страница 115: ...oom temperature relative humidity and altitude above sea level of the examination site c Measured values for room temperature relative humidity and altitude above sea level d Case temperature e BTPS conversion factor f ATPS values will be used yes no no BTPS conversion g Select the check box if you do not want to enter ambient conditions for two hours or until a restart Otherwise remove the check ...

Страница 116: ...ct your ndd dealer When you start a test you see the message Check spirette insertion The spirette is not correctly positioned Ensure that the triangle on the spirometer is lined up withthetriangleonthe spirette Calibration check outside 3 5 The spirette is not correctly positioned Insert the spirette as described in section InsertingtheOne Way Valve DLCO barriette FRC barriette and spirette on pa...

Страница 117: ...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 Accuracy from 0 to 5 0 05 from 5 to 10 0 20 10 not specified Mouth pressure transducer Measuring range 100 mbar Accuracy 1 Predicted values spirometry NHANES III Knudson_83 Knudson_76 Crapo Mor ris Hsu Dockery Harvard Polgar Gutierrez Canad...

Страница 118: ...B 30 to 75 no condensation Atmospheric pressure 700 to 1060 hPa Storage transport Temperature 20 to 50 C 4 to 122 F Relative humidity 5 to 95 no condensation Atmospheric pressure 500 to 1060 hPa Certifications CE Declaration of conformity Device classification Protection class I Type BF applied part Furthermore the device is not intended to be used in the presence of oxygen rich environments Howev...

Страница 119: ... 100 3150 1 FRC barriette pkg of 40 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 300...

Страница 120: ...atic system interpretation can be selected and deselected on the configuration tab see General Tab on page 100 GOLD Hardie Interpretation The following diagram outlines the criteria EasyOne Pro applies in the automatic interpretation after GOLD HARDIE see Literature on page 165 12 13 ...

Страница 121: ... 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 ...

Страница 122: ...Appendix 122 EasyOne Pro EasyOne Pro LAB NICE Interpretation Predominantly used in Great Britain Source unknown 1 FER FEV1 FVC ...

Страница 123: ...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 recommended Normal Spirometry At COPD risk Normal Spirometry at COPD risk No pred...

Страница 124: ...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 measurement value If this ch...

Страница 125: ...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...

Страница 126: ...f 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 8...

Страница 127: ...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 ...

Страница 128: ...date and time and will be shown 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 measurement value check box is selected 01380006310 014810001385 0128315EDV 0128316NDD 014921802 00 01230006 0 0183101Appeldorn 0173102Heinrich 017310323101945 01031101 0123622178 011362366 015840...

Страница 129: ...8470Predicted 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 01484203 67 0108421L 0...

Страница 130: ...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...

Страница 131: ...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 Example...

Страница 132: ...th FEV1 FVC 70 TLCsb is a systematically underestima ted 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 FEV...

Страница 133: ...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 pre sent 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 ...

Страница 134: ...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 2 left Select the test to which you want to add the logo Fig 12 2 right Fig 12 1 Report tab Fig 12 2 New Report button left test selection right ...

Страница 135: ...EasyOne Pro EasyOne Pro LAB 135 Appendix Select the Picture Box Fig 12 3 Insert the frame in the appropriate position Fig 12 4 Fig 12 3 Picture Box button Fig 12 4 Positioning the frame ...

Страница 136: ...5 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 7 Select Detail Report Graph Fig 12 7 Click graphVT1 Fig 12 5 Image button Fig 12 6 New Report Open buttons ...

Страница 137: ...e Spiro Graph Configuration window will be dis played Fig 12 9 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 7 Windows Report Explorer Detail Report Graph buttons Fig 12 8 Detail Report Graph window Fig 12 9 Spiro Graph Configuration window ...

Страница 138: ...mal 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 5...

Страница 139: ...east 30 Electrical fast transient burst to EN 61000 4 4 2 kV for power supply lines 1 kV for input output 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 interruptions and voltage variations on power supply input lines to EN 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60...

Страница 140: ...d separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 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 output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF trans...

Страница 141: ...yOne Pro b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communication equipment and EasyOne Pro EasyOne Pro is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled The customer or the user of EasyOne Pro can help prevent electromagnetic interferenc...

Страница 142: ... output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations E...

Страница 143: ...ation for Internet based services By using the software you accept these terms If you do not accept them do not use or copy the software Instead contact ndd Medizintechnik AG to determine its return policy for a refund or credit If you comply with these license terms you have the rights below 1 Use Rights You may use the software on the device with which you acquired the software 2 Additional Lice...

Страница 144: ... 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 Reverse engineer decompile or disassemble the software Make more copies of the software than specified in this agreement Publish the software for others to cop...

Страница 145: ...Internet protocol address the type of operating system browser and name and version of the software you are using and the language code of the device where you installed the software Microsoft uses this information to make the Internet based services available to you Web Content Features Features in the software can retrieve related content from Microsoft and provide it to you To provide the conte...

Страница 146: ...es 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 ...

Страница 147: ...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 regarding the device or the software do not originate from and are not binding on Microsoft or its affiliates When allowed by your local laws ndd Medizintechnik AG and Microsoft exclude implied warranties of merchantability fitness for a p...

Страница 148: ...Appendix 148 EasyOne Pro EasyOne Pro LAB These laws include restrictions on destinations end users and end use For additional information see www microsoft com exporting ...

Страница 149: ...art up and Initial Preparation on page 19 Performing a Test on page 40 System Settings on page 99 Index on page 167 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 system settings Sensor connected indicator Help button ...

Страница 150: ...nt selection 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 dele...

Страница 151: ... page 44 Index on page 167 Press the TAB or Enter key after each entry Click to close the window 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 ...

Страница 152: ...refer to Selecting a Test on page 44 Forced Vital Capacity FVC FVL on page 45 Vital Capacity SVC on page 55 Maximum Voluntary Ventilation MVV on page 57 CO Diffusing Capacity DLCO on page 59 Index on page 167 Test selection Selected patient Back to main menu Sensor connected indicator Help button Click to view patient data ...

Страница 153: ... on page 51 Components and Functional Description of EasyOne Pro on page 15 Index on page 167 Ambient conditions Selected patient Back to main menu Sensor connected indicator 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 ...

Страница 154: ...y Grades on page 72 Connecting the Printer on page 30 Index on page 167 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 ...

Страница 155: ... page 72 Connecting the Printer on page 30 Index on page 167 Click to select the displayed curve Selected patient Back to main menu Sensor connected indicator 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 ...

Страница 156: ...ing the Printer on page 30 Index on page 167 Complete exhalation Selected patient Back to main menu Sensor connected indicator Help button Click to view patient data Tidal breathing 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 control buttons Click to change the scale ...

Страница 157: ...sages and Quality Grades on page 72 Connecting the Printer on page 30 Index on page 167 Measurement curve Selected patient Back to main menu Sensor connected indicator Help button Click to view patient data Tidal breathing Click to enter a test evaluation Click to enter a comment Click to show hide the keypad Tracer curve Click to recalculate the curve ...

Страница 158: ...uality Grades on page 72 Connecting the Printer on page 30 Index on page 167 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 ...

Страница 159: ...age 69 Definition of Important Parameters on page 85 Index on page 167 Selected patient Sensor connected indicator 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 ...

Страница 160: ...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 calibrate the touch screen Click to perform a data backup Remote support Selected patient XML Export ...

Страница 161: ... page 99 Index on page 167 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 ...

Страница 162: ... Pro Flow Sensor Design and Operation on page 16 Specifications on page 117 Index on page 167 Selected patient Sensor connected 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 ...

Страница 163: ...16 Specifications on page 117 Index on page 167 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 reference control values Deselect a test remove check mark ...

Страница 164: ... 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 nitrogen concentration at the end of breath k and C0 is the end tidal nit...

Страница 165: ...imited since reference values from larger groups are not yet available 12 11 Literature 1 American Thoracic Society Standardization of Spirometry 1994 Update Nov 11 1994 Am J Resp Crit Care Med 1995 152 1107 1136 2 Occupational Health and Safety Administration OSHA Pulmonary Function Standards for Cotton Dust 29 CFR 1910 1043 Appendix D 3 Social Security Administration Disability SSD Guidelines CF...

Страница 166: ... 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 Testing in Preschool Children Am J Respir Crit Care Med Vol 175 pp 1304 1345 2007 16 Wanger J L Clausen et al ATS ERS Task Force Standardization of Lung Function Testing Standardisation of the measurement of lung volumes Eur Respir J 2005 26 511 ...

Страница 167: ...e preparation 22 Disposal 98 DLCO acceptability and quality grades79 DLCO barriette 33 DLCO Calibration check 94 DLCO gas supply 25 DLCO measurements adjustment 130 DLCO quality messages and grades 76 DLCO tab 109 DLCO test 59 DLCO test gas requirements 17 DLCO test contraindications 14 E EasyOne Pro LAB 12 EasyOne Pro LAB functions 14 EasyOne Pro tab 111 EasyOne Pro flow sensor 16 EasyOne tab 112...

Страница 168: ...arameter definitions 85 Parameter select 107 Parameters definition 85 Patient data edit 71 Patient selection 40 41 Post test 52 Power 32 Predicted values 123 Pre test 52 Printer driver select 113 Printer tab 113 Printer connect 30 Q Quality grade 49 Quality grades 72 Quality messages 72 Quick Test 59 R Rear panel 21 Report tab 113 Revision history 6 S Safety Information 8 Screen displays quick ref...

Страница 169: ...EasyOne Pro EasyOne Pro LAB 169 Trend view 69 Troubleshooting 116 U Units select 102 Update of the software 92 USB ports 21 User Handling tab 104 V Volume 102 W Warning definition 8 Warranty 7 ...

Страница 170: ...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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