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1. 2 0 SPIROMETER lan Gia pa aieka aera pi eiterik iro 10 6 2 EASYONE MODEL 207 O CRADLE u a was aaa 11 DEFINITION OF PARAMETERS oicsccccscesssssscsccscecicsesesctecccecectcenstivscceeudecoscevebcsescdscevesssisecesdsceeeseddoessesscees 11 8 SYSTEM CONFIGURATION Eak eae aaa ateak aaa 12 daa Gian ga 12 8 2 GENERAL SETTINGS erit ak nn Can bo oe bag Sek Sea shade Sus etaz Hen dosha San araka d 13 8 3 PRINTER EUNE a reak E a tak RR da a es EHEN Penn Sede CS ae Sa bert a iak daera 14 9 TEST TYPES zz garan zarteari azea Earra a arian ateta eak Earra 15 BERO ALSASUA 15 9 2 EVICINSPIRATION AND EEI ENUON aaria rre ea eae ara Eee erun 15 9 3 ANALA 16 SUOW areri aar ae E Barmen sos EES 16 9 55 AROEN ea a a e e e a ea aea 16 976 ADBINGATRAL SS e aA a aaa e aa aea 17 10 QUALITY MESSAGES AND QUALITY GRADEG scsccscccscccsscscccssccsscncccesccsscceccnsccesccsccesccescssccesceess 17 10 1 QUALITY MESSAGES etu ZE al E ta E A a ET ATE A A ar e iee 17 10 2 6 ae RR SR EDLER ORTEN en ada ibe tart airez 18 11 INTERPRETATION 3 ccscccscoscsssesssccctoessssccscescccccnes eee Eak eea aa 19 12 PREDICTED VALUES urka EEEk ebake eai aaa apara aan agak 20 12 1 PREDICTED VALUES F R ADULTS 2 ar aea 20 12 22. Measurement principle 83 x 158 x 43 millimetres 3 3 x 6 2 x 1 7 inches 255 grams 9 ounces Volume 3 0 050 Flow 5 or 0 200 1 5 except PEF 10 or 0 400 1 5 accuracy 5 0 200 1 5 MVV 10 or 15 l min Volume 0 5 to 8 Flow 14 1 5 less than 1 5 cm H O L sec 64 x 160 graphic display 14 key keyboard for up to 700 tests FVC FVL Slow VC MVV Pre Post FVC MVV FEV6 FEV1 FEV1 FVC FEV1 FEV6 MEF25 MEF50 MEF75 MEF25 75 PEF FET FIVC PIF IVC VC FEV1 VC ERV IRV pre post variation Lung Age Disposable spirette respiratory tube Ultrasound transit time measurement EasyGuide Page 11 Predicted Power supply Battery service life Report Storage Operating conditions Certifications and standards Instrument classification ERS Barcelona Austria NHANES Ill Knudson 1976 Knudson 1983 Crapo Morris Cherniak Paediatrics Zapletal Dockery Hsu 2 AA batteries approx 400 tests A4 or 8 5 x 11 in conjunction with a printer compatible with HP Canon or Epson Temperature 40 to 70 C Relative humidity 0 to95 Ambient pressure 500 to 1060 hPa Temperature 0 to 40 C Relative humidity 0 to 95 Ambient pressure 500 to 1060 hPa European Council Directive 93 42 EEC 14 6 1993IEC 601 EN 60601 international European Standard for Medical Devices EasyOne meets or exceeds the published targets of the Euro pean Respiratory
3. next good tests and the test is complete Blast out harder Peak flow not reproducible The test differs greatly from previous only in Frontline Difference with respect to best best test The patient can blow even mode test greater than 1 0 l s more firmly and achieve a higher peak flow Deeper breath FEV1 or FVC not reproducible The test differs greatly from previous Difference with respect to best tests The patient can inhale even test greater than 150 ml more deeply and exhale even more air Test complete Three acceptable tests FEV1 The test is complete An adequate and FVC within 200 ml 250 ml number of good tests is available after 5 trials when using FEV6 instead of FVC FEV6 is also used for the determination of the quality message EasyGuide Page 18 10 2 Quality Grades The quality grades allow you to assess the reliability of the measurement result Quality grades A to indicate a reliable result A quality grade between D and F indicates inadequate test quality The result must then be interpreted with caution The quality ratings can be activated or deactivated under Configuration See also Chapter 8 The table below defines the criteria for the classification of quality grades Rating Criteria in Diagnostic mode Criteria in Frontline mode A At least 3 acceptable tests AND the At least 2 acceptable tests AND the difference between the best two FEV1 di
4. in the main menu and then choose RECALL Follow the rest of the instructions In order to view an old test choose View Results in the main menu and choose the desired test 5 7 Quick Test You have the option to perform a quick test without entering patient data Select Perform Test inthe main menu and then QUICK Choose the desired test using the arrow keys and press ENTER Please note When Quick Test is selected no comparison to predicted normals are displayed or printed Predicted normals are only available when age height and gender are entered It is possible to enter patient data after having performed a quick test Proceed as described in Chapter 5 8 Once patient data is entered predicted normals will be displayed and printed 5 8 Editing Patient Data You have the option of editing or adding patient data after a test has been performed To do this choose Edit Patient Data in the main menu and press ENTER Choose the desired test with keys lt and gt and make the changes Please note Editing patient data may influence predicted computation and interpretation of the test result You should thus recheck the measured result when age height or gender are changed 6 Specifications 6 1 EasyOne Model 2001 Spirometer Size Weight Measuring accuracy Measuring range Resistance Display Data entry Data memory Test modes Parameters Respiratory tube
5. measurement in accordance with the recommendations of the National Lung Health Education Program NLHEP 4 The differences between the two operating modes are described in the table that follows Diagnostic mode Frontline mode Test modes FVC expiratory F V Loop inspi FVC expiratory Pre Post ratory and expiratory slow VC measurement MVV Pre Post measurement Parameters FEV1 FVC FEV1 FVC FEV6 FEV1 FEV6 FEV1 FEV6 FVC FEV1 FEV6 MEF25 75 MEF25 FEV1 FVC PEF pre post MEF50 MEF75 PEF FET FIVC variation QC rating PIF IVC IRV ERV FEV1 VC MVV pre post variation QC rating Quality control Requires 3 acceptable repro Requires 2 acceptable repro ducible maneuvers ducible maneuvers Details in Chapter 10 1 Details in Chapter 10 1 Automatic quality Quality control can also be over Automatic control is always active control ridden manually Trial storage and Can store and display the best Stores and displays only the best display or the best 3 trials including trial and curve curves Report Report can be customized for Report is fixed showing the Configuration curve type and size smaller sized FV and VT curves The default setting of the EasyOne Spirometer is the Diagnostic Mode To switch the EasyOne into the Frontline Mode see Chapter 8 under General Settings EasyGuide Page 3 2 Warning Information The following terms are used
6. 3 best tests on the report Number of 3 best curves best curve Choose if you want to print the 3 best Curves curves of the tests or only the best curve EasyGuide Page 15 Default setting best curve It is only possible to print the 3 best curves if the 3 best curves were saved see test settings Save curve data Relates to Options Description Graph Types FV amp VT small FV FV amp VT Choose what curves you wish to have on large VT large small the report FV amp VT large Header Optional entry Blank You can enter the name and address of 1 4 the institution or other information in 4 lines of 40 characters each 9 Test Types When you enter the patient data or select an existing patient you will see the Test menu with the following selection options FVC expiration FVL inspiration and expiration MVV Slow VC It is also possible to add a Post test to a FVC or FVL Test The various measurement methods are outlined below Good co operation on the part of the patient is essential with all methods Consequently you should explain to the patient clearly beforehand what he or she has to do and motivate the patient to co operate Choose the required measurement method with keys or id and confirm with ENTER 9 1 FVC expiration This is the most commonly used spirometric measurement Prepare the patient as described in Chapter 5 1 before you start the t
7. In this case each trial can be accepted manually To do so simply select ACCEPT after the manoeuvre and the trial will be considered acceptable EasyGuide Page 19 11 Interpretation The diagram below describes how the interpretation is determined Automatic interpretation can be activated or deactivated under Configuration see Chapter 8 Reference Enright PL Hyatt RE Office spirometry Lea amp Febiger Philadelphia 1987 Caution Interpret with care no normal spirometry low vital capacity possibly due to restriction of lung vol yes normal spirometry mild obstruction moderate obstruction severe obstruction and low vital capac possibly due to restriction of lung vol Notes 1 LLN Lower Limit of Normal Where FVC is indicated in chart FEV6 may be substituted if used 3 Where there is no lower limit of normal LLN defined within the selected predicted normal the value used for LLN for FEV1 FVC is 90 predicted and for FEV1 and FVC is 80 of predicted START test session good FEV1 gt 60 predicted FEV1 gt 40 predicted N EasyGuide Page 20 12 Predicted Values EasyOne offers a number of published predicted value tables allowing comparison of the measurement results In order to compute the predicted values it is necessary to enter the sex age and height and in many cases the ethnic group and the weight of the patient See also Chapter 8 on s
8. PREDICTED VALUES FOR CHILDREN 0c essscccesssecccsvesscceovesacesstevecssedecoscctencescadecnsscedooevedaeoescccuevssdeadesscccevesscedevece 20 13 HYGIENE AND SERVICING OF THE INSTRUMENT cccscccscccssccsscscccscccsscneccnsccescnsccesccescesccesccescesscees 21 14 CHECKING CALIBRATION riei eerzud a abazera ENa aketa baaa EAEra 22 15 TROUBLESHOOTING TIPS arara aizan ea aaa aak Ea aketen 23 16 BIBLIOGRAPHY AENA AAA 25 Copyright 2002 by ndd Medizintechnik AG Switzerland All rights reserved EasyOne and spirette are protected by the following patents EP 0597060 EP 0653919 US 5419326 US 5503151 US 5645071 US5647370 EasyGuide Page 2 1 Introduction Thank you for choosing the EasyOne Spirometer With EasyOne you have chosen a high quality spirometer that minimizes the need for maintenance due to its unique ultrasound technology EasyOne does not need calibration and remains consistently accurate over years The spirette breathing tube assures perfectly hygienic conditions for every patient at low cost even if the spirometer is frequently used The EasyOne Diagnostic Spirometer has two operating modes for you to choose from In the Diagnostic mode EasyOne offers you extensive and diverse options for spirometric tests in accordance with the standards of the European Respiratory Society ERS and the American Thoracic Society ATS In the Frontline mode EasyOne offers you the option of greatly simplified spirometric
9. Problem Possible cause Solution When printing a report the printer prints meaningless characters A wrong printer type has been selected in the settings Set the correct printer Read Chapter 8 2 The printer cable is not correctly connected or is defective Switch off the spirometer and printer Check all plug connections The printer does not respond The printer is not switched on or is not ready Ensure that the printer is switched on and also has paper Switch the printer off and back on again The printer cable is not correctly connected or is defective Switch off the spirometer and printer Check all plug connections EasyOne is not correctly positioned on the base unit Insert EasyOne correctly into the base unit When switching on the instrument the message device self test error 20 appears onthe screen A Spirette was inserted while turning onthe instrument OR was not inserted correctly Try again with the spirette inserted correctly If you receive the same message again contact your EasyOne dealer When starting a new test the message device selftest error 14 or 15 appears in the screen the spirette is not positioned correctly Insert the spirette as described in Chapter 4 1 When switching on the instrument the message device selftest error 25 appears on the Screen The internal battery ofthe EasyOne may be defe
10. Society the American Thoracic Society CSA International CAN CSA C22 2 601 1 M90 51 94 CSA 601 1 Amendment 2 1998 UL Std No 2601 1 CE Certificate Type BF instrument Powered internally with 2 AA alkaline batteries Short time operation less than 10 minutes Instrument not suitable for use in flammable anaesthetic gases in mixtures with O or NO 6 2 Model 2010 Cradle Size Weisht Power supply Function Interface Storage Operating conditions 119 x 173 x 83 millimetres 4 7 x 6 8 x 3 3 inches 284 grams 10 ounces From the batteries of the EasyOne spirometer Connects the EasyOne spirometer to a printer or PC Standard USB type A and B connectors alternatively DB25 connector for serial or parallel interface for connection to PC or printer Temperature 40 to 70 C Relative humidity 0 to 95 Ambient pressure 500 to 1060 hPa Temperature 0 to 40 C Relative humidity 0 to 95 Ambient pressure 500 to 1060 hPa 7 Definition of Parameters FVC FIVC FEV1 FEV6 FEV1 FVC Forced Vital Capacity expiratory Forced Vital Capacity inspiratory Forced Expiratory Volume 1 sec Forced Expiratory Volume 6 sec Ratio of FEV1 to FVC EasyGuide Page 12 FEV1 VC FEV1 FEV6 MEF 25 MEF 50 MEF 75 MEF 25 75 PEF PIF FET PRE POST variation Ratio of FEV1 to VC taken from SVC test Ratio of FEV1 to FEV6 Forced Expir Flow at 25 of Vital capacity Force
11. Volume 127 1983 p 725 734 6 Crapo Robert O Gardner Reed M Morris Alan H Reference Spirometric Values Using Techniques and Equipment that Meets ATS Recommendations American Review of Respiratory Disease Volume 123 1981 p 659 674 7 Forche G Harnoncourt K Stadlober E Neue spirometrische Bezugswerte f r Kinder Jugendliche und Erwachsene Ost Arzteztg 43 15 16 1988 40 8 Quanjer Lung Volumes and Forced Ventilatory Flows Eur Respir Vol 6 Suppl 16 p 5 40 1993 9 NHANES Ill Hankinson Odencrantz Fedan Spirometric Reference Values from a Sample of the General U S Population Am J Respir Crit Care Med Vol 159 1999 179 187 12 2 Predicted Values for Children 1 Zapletal Paul Samanek Die Bedeutung heutiger Methoden der Lungenfunktions diagnostik zur Feststellung einer Obstruktion der Atemwege bei Kindern und Jugend lichen Z Erkrank Atm Org Volume 149 343 371 1977 2 Hsu Bartholomew PH Thompson V Hseih GSJ Ventilatory Functions of Normal Children and Young Adults Mexican American White Black Spirometry J Pediatrics 1979 95 p 14 23 3 NHANES Ill Hankinson Odencrantz and Fedan Spirometric Reference Values from a Sample of the General U S Population Am J Respir Crit Care Med Vol 159 1999 179 187 4 Dockery D W et al Distribution of Forced Vital Capacity and Forced Expiratory Volume in One Second in Child
12. as follows in this document Caution Please note Possibility of injury or serious damage Important information for avoiding damage to the instrument or facilitating operation of the instrument Please note the following information on safe operation of the EasyOne spirometer N means Read the User Manual Caution The instrument is not suitable for use in the presence of explosive or flammable gases Caution Connect only printers and computers that comply with IEC 950 Standards for safety of information technology equipment orthat bearthe UL or CSA mark Caution For AA batteries do not attempt to charge connect improperly or dispose of in fire as there is possibility of leakage or explosion Follow manufacturer s recommendation for proper disposal Caution Calibration and servicing may be carried out only by ndd staff Do not open the instrument Caution Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness Please note Use only alkaline batteries and remove the batteries from the battery compartment if you intend not to use the instrument for a long period EasyGuide Page 4 3 Intended Use The ndd EasyOne is designed for conducting simple spirometric measurements on adults and children over the age of 4 by general practitioners specialists in occupational medicine and in hosp
13. the instrument when cleaning the spirometer No maintenance or Servicing are required apart from changing the batteries Please consult your EasyOne dealer or call the ndd Servicing Dept number 41 1 445 29 70 in the event of defects or malfunctions Proceed as follows to check correct operation of your instrument 1 Check calibration Please read Chapter 14 2 Conduct a spirometry test on yourself 3 Ensure that the results are plausible and that you can print out the report as required Consult your EasyOne dealer if you encounter problems with one of these points EasyGuide Page 22 14 Checking Calibration Calibration of the instrument can be checked with a syringe using the calibration check function The American Thoracic Society ATS recommends that calibration be checked every day The EasyOne spirometer requires no calibration even if used frequently To perform a calibration check you need the ndd calibration adapter and a calibration syringe in addition to the spirometer and a spirette Ensure that the correct syringe volume is entered in the instrument s configuration setting see also Chapter 8 Proceed as follows e Choose item Check calibration in the main menu e Connect the spirometer as shown below using the calibration adapter and the syringe Ensure that the piston is fully inserted and at the stop position Now press ENTER Wait until the baseline has been set and you hear an a
14. OOO EasyGuide OGG M EasyOne Spirometer ndd Medizintechnik AG Technoparkstrasse 1 CH 8005 Zurich Switzerland www ndd ch 2070 3EU_EN_V50 doc EasyGuide Page 1 Contents 1 INTRODUCTION cisiisssceciccescccies ceticccedue bosses decscdasseueseecesSecessucsieevecedeesdeavecededdesescdessboseseetseutecoessbesessesesaccs 2 2 WARNING INFORMATION oscssssistvscsisccdsescsccncatiscadaicescvedesctnlasdessteosdesvsssestscusesesevcsdsessvevsescdsssbaesedseedeuseesie 3 3 INTENDED USE GREAT 4 4 INSTRUMENT INSTALLATION cssicccciecsssisssssedcoccvcdessseebecedencecessebsccsesesepavecbeseececsdcdvasessseveseccesdeasssavececoesanss 4 41 SETTING UP THE INSTRUMENT Senne ana Ede aere ear iak e E Ee 4 4 2 SETTING LANGUAGE DATE TIME ALTITUDE ABOVE SEA LEVEL AND PRINTER TYPE a 5 OPERATING THE KEYS ataa aeta aaa da a E a E ae iagi 6 5 PERFORMING SPIROMETRY GORAKO 6 551 PREPARING THE PATIENT Metelen dake aienea 6 5 2 MEASURING THE FORCED VITAL CAPACITY aa 7 53 CHECKING THE TEST QUALITY ara aa ed aa ae a i d E eee 8 5 4 gt INTERPRETING RESULTS a aa a A E a e a a ed ie 9 5 5 SPRINTING A KERO e a a a a a a e age 9 5 6 SAVING AND RETRIEVING MEASUREMENTS ssseccccssscccsesscccceessccceasscccsensccceaaseccseaesccsseecceeaascceseaescesseasecssaeeseess 9 5 7 QUCK ga AAE 10 5 8 EDITING PATIENT DATA aan nal lan dann 10 6 HIGA Sl due LAAEN 10 6 1
15. ank space or a zero 5 Performing Spirometry 5 1 Preparing the Patient Prepare for testing by having the patient loosen tight clothing remove dentures and relax The patient may sit or stand If standing you may want to perform testing in an area free of sharp table or counter edges or have a chair handy as there is a slight possibility that the patient could faint during the strenuous spirometry maneuver Explain that the purpose of the test is to determine how much air a person s lungs can hold and how quickly that air can be expelled with a forceful maximal effort Since the spirometry test requires active participation by the patient it is very important to demonstrate the maneuver for the patient Emphasize the essential elements of the test EasyGuide Page 7 e filling lungs completely e sealing lips around the spirette so that there are no leaks taking care not to block its opening with teeth or tongue or bite down excessively e blasting out as hard and fast as possible e continue blowing out until the lungs are completely empty If you are new to spirometry you should practice testing yourself and others prior to testing patients You will learn to recognize a poor effort by observing the patient and or interpreting the Quality Messages displayed by the spirometer after each effort After a poor effort you must explain what went wrong Develop enthusiastic coaching techniques to use during the maneuver to maximiz
16. apter 9 1 and 9 2 EasyGuide Page 17 9 6 Adding a Trial If you would like to add trials to a previous test e g if the patient needed a break please proceed as follows e Select Perform Test in the main menu Choose the field RECALL and press ENTER Scroll through the list of tests until you get to the desired test and press ENTER Select the field ADD Proceed as described in Chapter 9 1 and 9 2 Please mind that it is only possible to add a trial to a previous test that was performed on the same day 10 Quality Messages and Quality Grades 10 1 Quality Messages The quality messages assist you in conducting the measurement After each test they provide information as to whether the test is acceptable or what to do to improve the result Message Criterion Recommended action Don t hesitate Back extrapolated volume The patient must exhale all air at greater than 150 ml 5 once and not exhale in short bursts whichever is greater Blast out faster Time until peak flow greater The patient must exhale more than 120 ms explosively and as firmly and quickly as possible Blow out longer Expiration time less than 2 The patient stopped exhaling too seconds or volume early The patient must exhale still accumulation has not dropped further and force as much air as below 100 ml per 0 5 seconds possible out of his or her lungs Good effort do Test meets above criteria Good test Only one to two more
17. asyOne on or off Press and hold the key for at least 2 sec until you hear an audible signal ENTER This confirms data entry or the selection and moves you to the next entry field DA Deletes last character scrolls to the left or up 0 Scrolls to the right or down 0 ESC Press the key briefly in order to enter 0 keep the key pressed longer at least 1 sec in order to return to the previous field with ESC or abort the operation press the key briefly twice in order to enter a blank the key function operates only if letters can be entered 2 abc etc Press the key briefly in order to enter the digit 2 press the key briefly in order to enter A the key function operates only if letters can be entered press the key briefly twice in order to enter the key function operates only if letters can be entered if you press the same key quickly several times consecutively you will scroll first to the upper case letters then to the number and then to the lower case letters Umlauts and special characters can be found on key 1 Please note The escape key 0 is particularly helpful and important in unit navigation The escape function requires the key to be pressed and held momentarily Escape is useful for moving to previous menus items or fields and escaping a spirometry test Pressing this key rapidly in fields where letters are possible such as patient name and report header allows the entry of a bl
18. bottom diagnostic EasyOne GEO Ooo o If you wish to print reports or export data to a PC connect the EasyOne base unit to the printer or to the PC using the corresponding cable Caution Connect only printers and computers that comply with IEC Standards for safety of information technology equipment or that bear the UL or CSA mark 4 2 Setting Language Date Time Altitude above sea level and Printer Type Press the ON OFF key for at least 2 seconds in order to switch on the instrument The instrument switches off automatically if no key is pressed for 15 minutes If you are switching on the instrument for the first time you will be prompted to choose the language and to enter the date time altitude above sea level and approximate relative humidity at the instrument s location This data is not pre set If you intend to print reports you can also select the right printer type on the instrument EasyGuide Page 6 The spirometer is delivered with the pre set default settings Please refer to Chapter 8 of this User Manual for the procedure for changing the settings Adapting the settings to your needs allows you to get the most out of your EasyOne instrument After you have made the above settings when switching on the instrument for the first time you can then change any settings at any time using the CONFIGURATION menu item from the main menu 43 Operating the Keys ON OFF This switches E
19. ct Switch the EasyOne off and on again Ifthe same message appears again please contact your EasyOne dealer EasyGuide Page 25 16 Bibliography 1 2 3 4 5 6 7 8 9 American Thoracic Society Standardization of Spirometry 1994 Update Nov 11 1994 Am J Resp Crit Care Med 1995 152 1107 1136 Occupational Health and Safety Administration OSHA Pulmonary Function Standards for Cotton Dust 29 CFR 1910 1043 Appendix D Social Security Administration Disability SSD Guidelines CFR404 Appendix 1 to Subpart P Ferguson GT Enright PL Buist AS et al Office spirometry for lung health assessment in adults a consensus statement from the National Lung Health Education Program Chest 2000 117 1146 1161 ATS Pulmonary Function Laboratory Management and Procedure Manual American Thoracic Society New York NY 10019 Enright PL Hyatt RE Office Spirometry Lea amp Febiger Philadelphia 1987 Hyatt RE Scanlon PD Nakamura M Interpretation of Pulmonary Function Tests A Practical Guide Lippincott Raven Philadelphia 1997 American Thoracic Society Lung Function Testing Selection of Reference Values and Interpretative Strategies Am Rev Respir Dis 1991 144 1202 1218 Morris JF Temple W Short Report Spirometric Lung Age Estimation for Motivating Smoking Cessation Preventive Medicine 14 655 662 1985 2070 3EU_EN_V50 doc
20. d Expir Flow at 50 of Vital capacity Forced Expir Flow at 75 of Vital capacity Forced Expir Flow at 25 75 of Vital capacity Peak Expiratory Flow in l min or l sec Peak Inspiratory Flow Forced Expiratory Time Percentage variation of measured values before and LLN BEV VT ERV IRV VC or VCmax VCex VCin IC MVV Lung Age after bronchial spasmolysis Lower Limit of Normal Back Extrapolated Volume Tidal Volume Expiratory Reserve Volume Inspiratory Reserve Volume Maximum Vital Capacity Expiratory Vital Capacity Inspiratory Vital Capacity Inspiratory Capacity Maximum Voluntary Ventilation per min Lung Age see Chapter 17 for reference 8 System Configuration If you wish to change the instrument setting please choose the Configuration option in the main menu You will now be in the Configuration menu The tables below provide an overview ofthe setting options offered to you by EasyOne Choose the option you require 8 1 Test Settings Relates to Options gat Description setting Predicted ERS Zapletal ERS You can select your desired predicted Austria Barce Zapletal values from the predicted publications lona NHANESIII listed Knudson 76 Knudson 83 Crapo Morris Additional Dockery Hsu None You have the option of selecting different paediatrics none predicted values for children than those for adults Best value Best value best Besttest In best value s
21. e your chances of getting quality results with a minimum number of efforts Caution Pulmonary function tests require maximum effort on the part of the patient and may lead to dizziness or giddiness 5 2 Measuring the Forced Vital Capacity FVC e Choose Perform Test in the main menu and then NEW Confirm with ENTER The instrument will now allow you to enter the patient data e Enter the corresponding patient data line by line Use the keys as described in Chapter 4 3 Confirm with ENTER each time e After entering the patient data you then move on to the Test selection menu Choose the FVC test and confirm with ENTER e Insert a spirette into the instrument Ensure that the arrow on the spirette is lined up with the arrow on the instrument e Once again briefly prepare the patient for the test When the patient is ready press ENTER You will now hear the sensor buzzing The instrument now prompts you to avoid air flow in the spirette since it is setting the baseline It is advisable to block off the spirette on one end in order to ensure that the baseline is set precisely even if the room is draughty An audible signal will sound when the baseline has been set You will see prompt Blast out on the screen e Hand the instrument to the patient Ask the patient to breath in deeply insert the spirette correctly into his or her mouth Now ask the patient to exhale as firmly and as quickly as possible and continue exha
22. election of the predicted values If no lower limits LLN are defined in the predicted publication EasyOne uses 80 of the predicted value to interpret FEV1 and FVC resp FEV6 and uses 90 of the predicted value in the case of ratios e g FEV1 FVC If the patient data lies outside of the range defined in the publication EasyOne uses extrapolated values The report explicitly points out that the predicted values are extrapolated values and that consequently particular caution must be taken when interpreting the results 12 1 Predicted Values for Adults 1 Morris James F Koski Arthur Lavon Johnson Spirometric Standards for Healthy Non Smoking Adults American Review of Respiratory Disease Volume 10 3 1971 p 57 67 2 Morris James F Koski Arthur Breese John Normal Values and Evaluation of Forced Expiratory Flow Am Rev Respir Dis Vol 111 1975 p 755 761 3 and Raber Normal Standards for Ventilatory Function using Automated Wedge Spirometer Am Rev Respir Dis Vol 106 1972 p 38 46 4 Knudson Ronald J Ronald Slatin Michael Lebowitz Benjamin Burrows The Maximal Expiratory flow Volume Curve American Review of Respiratory Disease Volume 113 1976 p 587 600 5 Knudson Ronald Michael Lebowitz Holberg Catherine Benjamin Burrows Changes in the Normal Maximal Expiratory Flow Volume Curve with Aging American Review of Respiratory Disease
23. est Then proceed as follows e Insert a spirette into the instrument When doing this please ensure that the arrow on the Spirette is lined up with the arrow on the instrument e Press ENTER when the patient is ready You will now hear the sensor buzz The instrument prompts you to avoid flow in the spirette while it is setting the baseline It is necessary to block off the spirette at one end in order to ensure that the baseline is set precisely An audible signal sounds when the baseline is set You will see the prompt Blast out on the screen e Hand the instrument to the patient and ask the patient to breath in deeply first then to insert the spirette correctly into his or her mouth to exhale as firmly and quickly as possible and to continue exhaling until all the air has been exhaled e Atthe end of the manoeuvre you will see a message on the screen indicating whether the manoeuvre was acceptable At least three acceptable reproducible manoeuvres must be performed before you see message Session complete In Frontline mode only two acceptable reproducible manoeuvres need be performed 9 2 inspiration and expiration With this test mode a deep inhalation follows the exhalation manoeuvre directly Proceed in the same way as with the above described FVC test However instruct the patient not to EasyGuide Page 16 remove the spirette from his or her mouth after exhaling but to follow up with a deep maximum in
24. etting the relevant best selection test value from different tests is selected Best test selects the test which has provided the best results Interpretation Yes no Yes Automatic interpretation see Chapter 11 is activated or deactivated here Lung Age yes no no if set to yes the lung age is displayed on the result screen and printed on the report Lung Age is only shown if the EasyGuide Page 13 Relates to Options Default setting Description patient is a smoker Automated Test QC Yes no Yes The automated test QC see also Chapter 10 is activated and deactivated here FVC selection FVC FEV6 FVC FEV6 indicates the exhaled volume after 6 seconds When set to FEV6 EasyOne stops the measurement after 6 seconds MEF25 MEF50 MEF75 and MEF25 75 are not reported in that setting When set to FVC EasyOne continues the measurement until end of test criteria are met PEF unit 1 5 l min 1 5 Peak flow be specified in litres per minute or in litres per second African ethnic corr 75 110 88 The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group Asian ethnic corr 75 110 100 The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this et
25. fference between the two FEV1 and and FVC values is equal to or less than FEV6 values is equal to or less than 150ml 100ml or FVC is equal or less 150ml B At least 3 acceptable tests AND the At least 2 acceptable tests AND the difference between the best two FEV1 difference between the two FEV1 and and FVC values is equalto orlessthan FEV6 values is equal to or less than 150 200ml ml or FVC is equal or less 200 ml At least 2 acceptable tests AND the At least 2 acceptable tests AND the difference between the best two FEV1 difference between the two FEV1 and and FVC values is equal to less than FEV6 values is equal to or less than 200 250ml ml or FVC is equal or less 250 ml D At least 2 acceptable trials but the At least 2 acceptable trials but the results are not reproducible results are not reproducible Quality message Result not Quality message Result not reproducible OR only one acceptable reproducible OR only one acceptable trial Quality message Only one test acceptable trial Quality message Only one acceptable trial F No acceptable test available No acceptable test available If the Automated Test QC function is activated the instrument determines automatically which trial is acceptable For the evaluation of the best trial the interpretation and the Pre Post comparison acceptable trials are used first In the Diagnostic mode the Automated Test QC function can be deactivated see chapter 8
26. halation Three acceptable tests should be conducted with this test as well 9 3 MW e Insert a spirette into the instrument Ensure that the arrow on the spirette is lined up with the arrow on the instrument e Press ENTER when the patient is ready You will now hear the sensor buzz e The instrument now prompts you to avoid flow in the spirette while it is setting the base line It is advisable to block off the spirette at one end to ensure precise setting of the baseline An audible signal sounds when the baseline is set e The patient must then insert the spirette into his or her mouth and must fully inhale and exhale for an uninterrupted period of at least 12 seconds 9 4 SlowVC Slow spirometry serves to determine the vital capacity and the lung volumes see Chapter 7 You can repeat the manoeuvre several times The best test is saved Proceed as follows e Insert a spirette into the instrument Ensure that the arrow on the spirette lines up with the arrow on the instrument e Press ENTER when the patient is ready You will now hear the sensor buzz The instrument now prompts you to avoid flow in the spirette while it is setting the base line It is advisable to block off the spirette at one end to ensure the baseline is set precisely An audible signal sounds when the zero point is set e The patient must now insert the spirette into his or her mouth and breathe at rest about 3 5 breaths until you hear an audible signal e T
27. he patient must then take a deep inspiration followed by a maximum exhalation e The instruments stops automatically at the end of the manoeuvre If you are only interested in the vital capacity without determination of the other volumes ERV IRV VT IC the VC manoeuvre can also be performed without waiting for the acoustic signal At the end of the SVC test you can decide to immediately add an FVC test If you do so the parameter FEV1 VC Tiffeneau is also shown on the printed report of the FVC test 9 5 Post Test The Post Test is usually performed to determine the response on bronchodilating asthma medication This is done by treating the patient with a bronchodilator after having performed a FVC or FVL test Approximately 10 to 20 minutes after the medication when bronchodilator shows effect a second FVC or FVL test post Test is performed The results of the pre test and the post test are then compared on the result screen and on the test protocol Post Tests can only be added to previous tests on the same day To add the Post test immediately after the FVC or the FVL test select the field POST on the result screen When coming from the main menu you can add a post test to a previous test as follows e Select Perform Test in the main menu Choose the field RECALL and press ENTER Scroll through the list of tests until you get to the desired pre med test and press ENTER Select the field POST Proceed as described in Ch
28. hnic group Latin American ethnic corr 75 110 100 The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group Other ethnic corr 75 110 100 The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group Curve storage 3 best curves best curve best curve EasyOne can also save the 3 best curves of a test This is necessary if you want to print the 3 best curves or if you want to export the curve data of the three best trials Please note that saving 3 curves uses substantially more memory EasyOne can then only save about 250 tests before it starts to overwrite the first test 8 2 General Settings Relates to Options Default Settings Description Time format 24 hours am pm 24 hours Sets the time format for 12 or 24 hour Date format DD MM YY DD MM YY MM DD YY DD MM YY Sets the data format EasyGuide Page 14 3 Default Relates to Options Settings Description Current date Please enter the correct date at this point and confirm with ENTER Current time Please enter the correct time at this point and confirm with ENTER Alphanumeric Yes n
29. itals The EasyOne spirometer is used together with the spirette respiratory tube in order to conduct slow and forced spirometric maneuvers and MVV tests 4 Instrument Installation 4 1 Setting Up the Instrument Check that the supplied parts correspond to the parts listed in the EasyStart Quick Start Guide Install the two AA alkaline batteries included in the compartment on the rear of the spiro meter taking care to match the polarity marking on the batteries with the markings inside the battery compartment Caution Do not attempt to charge or burn the AA batteries used in the instrument Please follow the manufacturer s instructions on battery disposal Please note Use only alkaline batteries and remove the batteries from the battery compartment if you intend not to use the instrument for a long period Please note A low battery message will alert you when battery power falls below 10 Data saved in memory is not lost when battery power is low or when batteries are removed EasyGuide Page 5 Install the spirette as shown Be sure to orient the spirette so that the arrow on the spirette lines up with the arrow on the spirometer Push the spirette all the way in to the stop For maximum hygiene consider tearing the spirette bag from the bottom leaving spirette partially wrapped during insertion and until the spirometer is handed to the patient The spirette is easily removed by pushing it up from the
30. ling until all air has been exhaled e Atthe end of the manoeuvre you will see a message on the display indicating whether the manoeuvre was acceptable At least three acceptable manoeuvres must have been performed before you see message Session complete e Using keys gt 0 you can view the result on the screen In order to print the result choose the PRINT field and press ENTER Then place the instrument into the base unit The report is then printed EasyGuide Page 8 You can conduct the following tests with EasyOne FVC expiratory FVL inspiratory and expiratory pre post tests slow spirometry and MVV Please also see Chapter 9 5 3 Checking the Test Quality In order to assess the pulmonary function of the patient it is necessary to obtain acceptable test quality The test quality depends on co operation of the patient and this in turn depends on the quality of the physician s instructions Consequently EasyOne incorporates an auto matic quality control function with prompts to facilitate the physician s job of providing the patient with good instructions After each manoeuvre a message on the screen will inform you as to whether the manoeuvre was acceptable or not If not the message will guide you on how to coach the patient to do better A quality grading from A to F is displayed at the end of the test It provides information on the overall quality of the test Please refer to Chapter 10 2 for further inf
31. o No If the ID you use also consists of letters ID please set to Yes Technician ID Yes No If you want the technician ID to be saved as well and listed on the report please choose Yes Syringe 1 01 1 5l 7 01 3 01 Choose the volume of your syringe if you volume wish to use it to conduct a calibration check Height unit m cm ft inch m cm Choose how the unit will indicate height and altitude Weight unit kg 165 kg Choose how the unit will indicate weight Age date of Age date Date If you use a database consider entering birth the date of birth so that the age can be calculated correctly at a later point Contrast 30 63 40 Changes the display contrast Lang German English English Choose the desired language others Altitude above Om 4000m Om Set the altitude above sea level of your sea level location Op mode Diagnostic Diag see Chapter 1 Frontline nostic Temp unit BURRO Determines how temperature is reported Rel humidity 0 100 40 Enter the average relative humidity at your location 8 3 Printer Settings Relates to Options Default Description setting Printer type HP b amp w HP color HP b amp w Choose the right option to match your Canon b amp w available printer See Chapter 15 if you Canon color have problems Epson b amp w Epson color via PC Result data 3 best values best You have the choice of printing out only best values values the best test or the
32. ormation on the quality grades The table below gives you the possible prompts that EasyOne provides you with after a manoeuvre Prompt The prompts relates to How to improve Don t hesitate the quality of the last The patient should exhale in one breath test and should not stop in between Blast out faster the quality of the last The patient must exhale more explosively test and as firmly and quickly as possible Blow out longer the quality of the last The patient has discontinued exhalation test too early The patient must exhale even more and press as much air as possible out of his or her lungs Good effort do next the quality of the last Good test Just one to two more good tests test and the test is complete Blast out harder the reproducibility of The test differs greatly from the previous only in Frontline the maneuvers PEF is tests The patient can blow still more firmly mode non reproducible and achieve a higher peak flow EasyGuide Page 9 Deeper breath the reproducibility of The test differs greatly from previous tests the maneuvers FVCor The patient can inhale even more deeply FEV1 are non and exhale even more air reproducible Session complete The test is complete An adequate number of good maneuvers have been conducted Only one of the above prompts is shown after a manoeuvre As soon as you see message Session complete
33. ren 6 to 11 Years of Age American Review of Respiratory Disease Volume 128 p 405 412 1983 EasyGuide Page 21 13 Hygiene and Servicing of the Instrument EasyOne has been designed to minimise maintenance and Servicing effort if the instrument is used correctly When you use the spirette respiratory tube you do not need to clean the instrument Instead of cleaning you simply exchange the respiratory tube In order to ensure absolute hygiene we recommend that that the spirette be used only once However if you conduct only expiratory tests there is also the option of using reusable Spirette m respiratory tubes order No 2050 7 and exchanging only the mouthpiece order number 2051 from patient to patient Caution Always exchange the spirette if you suspect the risk of infection This is the only way of absolutely preventing transmission of diseases Please note The reusable spirette m respiratory tubes and mouthpieces are suitable only for performing expiratory manoeuvres When using the mouthpieces avoid the patient inhaling through the respiratory tube Also ensure that there is no fluid in the respiratory tube Correct measurement can be ensured only if using ndd mouthpieces Use a damp cloth to clean the spirometer housing and the base unit Use a soft cloth and alcohol e g isopropyl alcohol for particularly thorough cleaning Caution Avoid fluid penetrating the spirette holder or the inside of
34. tion of printing by selecting the PRINT field and confirming this with ENTER You will see message Please connect device to cradle Insert the instrument into the cradle and wait until the print job has been printed EasyOne issues an audible signal indicating when the instrument can be removed You can also print old tests to do this select option Print Results Single Test in the main menu choose the required test with key or 0 and press ENTER You can also print a number of tests at once by choosing Print Results Range of Tests and entering a start and end date You will once again see message Please connect device to cradle Depending on the type of printer it will take between 45 and 90 seconds to print out the report Should you have problems printing out please refer to the information in Chapter 15 5 6 Saving and Retrieving Measurements EasyOne saves all test results automatically No data is lost even if the batteries are removed The oldest test is overwritten when the memory is full up to 700 measurements You can recall saved measurements for the purpose of conducting a new test with the same patient adding manoeuvres adding a post test viewing results or printing results You can add a manoeuvre or a post test only on the same day that the original test was performed See Chapters 9 5 and 9 6 EasyGuide Page 10 In order to add a test to an old measurement choose Perform Test
35. udible signal Now execute one full inspiratory pump stroke followed by one full expiratory pump stroke at moderate speed e After you perform the manoeuvre you will see the text Accuracy confirmed at the top of the display and beneath it the percentage deviation and the average flow velocity of the pump stroke e You can repeat the test print the result or quit the program The calibration test remains stored and can also be viewed or printed out later If you do not reach 3 accuracy please follow the troubleshooting instructions in Chapter 15 Should you not be able to remedy the defect by following these instructions either please consult your EasyOne dealer Please note Field service or internal calibration of this unit is not recommended Cover should not be removed except by qualified service personnel EasyGuide Page 23 15 Troubleshooting Tips Should you encounter problems operating your spirometer please consult the table below Problem Possible cause Solution EasyOne cannot be switched on Batteries are dead Insert new batteries Batteries are inserted wrong Insert the batteries correctly see Chapter 4 1 Did not press and hold the ON OFF key for at least 2 seconds Press and hold the ON OFF key for at least 2 seconds When the EasyOne is switched on you hear three consecutive tones as a warning signal The spirometer is defective Consult your Eas
36. yOne dealer When the EasyOne is switched on you see the following message on the display Self test failed The spirometer is possibly defective Try again If you receive the same message again contact your EasyOne dealer Every time you switch the instrument on you are prompted to enter Date etc The internal battery of EasyOne is defective Consult your EasyOne dealer When you start a test you see the following message Please insert Spirette correctly The spirette is not correctly positioned Ensure that the triangle on the spirometer is lined up with the triangle on the spirette EasyOne is outside of 3 when conducting the calibration check The spirette is not correctly positioned Insert the spirette as described in Chapter 4 1 You have not used an ndd adapter Use the ndd calibration adapter There are leaks in the syringe connection Check the connections The specified syringe volume does not correspond to the actual syringe volume Choose the correct syringe volume under Configuration The curve is missing on the printout The color cartridge of your printer is empty Replace the cartridge In the configuration of your EasyOne a black and white printer is selected but you actually use a color printer Go to Configuration then Report Settings and select the right printer EasyGuide Page 24
37. you need not conduct further manoeuvres If even after repeated attempts it is not possible to obtain an adequate number of good manoeuvres you should take a break depending on how the patient feels or stop measurement Even after a break the measurement is stored and can be printed out under Print results in the main menu You also have the option of adding tests subsequently Read more on this in Chapter 9 6 5 4 Interpreting Results When interpreting the results it is important to allow for the quality rating of the test The quality ratings A to C indicate a reliable result A quality rating between D and F indicates insufficient test quality The result must then be interpreted with caution As soon as you obtain the message Test complete after conducting a test you can either print out the report immediately with ENTER or select the DATA field and view the result on the display On the printed report parameters that are below the lower limit of normal LLN are printed in red and marked with an asterisk EasyOne also offers an automatic interpretation aid Please refer to Chapter 11 for further information on this interpretation It is possible to deactivate both the QC Grade function and the Interpretation function To deactivate these functions see Chapter 8 5 5 Printing a Report You will require a base unit and a compatible printer in order to print a report Immediately after completion of the test you have the op
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