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CP 150 spirometry option Directions for use

1. Use even strokes in calibration Replace pressure tubing Connect to another USB port Replace the USB cable Load paper See the electrocardiograph manual If the paper is jammed clear it then reload Retest Retest Recalibrate with a 3 liter syringe See Performing a calibration 40 Troubleshooting Symptom Values are too high consistently Predictive values are blank The flow sensor has been dropped Report does not print parameters or graphs Patient test values differ from values expected by physician Possible cause Pressure connection is partially obstructed The selected norm does not support certain values and composite norm values are disabled Accident Improper parameter settings Various CP 150 spirometry option Suggested action Remove any foreign substance from the flow transducer or pressure tubing Re enter age birthdate height gender race Fill in the fields All mandatory fields must be filled in before you can proceed Enable composite norm values See Viewing or changing the spirometry settings Recalibrate See Performing a calibration Check print settings See Viewing or changing the spirometry settings If the transducer is contaminated with sputum or secretions replace it Verify that proper barometric pressure has been entered See Performing a calibration Verify the patient data Eliminate any leaks in the pressure u
2. EE No Feature Description 1 LCD screen 800 x 480 pixels color touchscreen provides a graphical user interface 2 Power switch and LED Power on Standby switch The LED indicates the charging status when connected to AC power e Green The battery is charged e Amber The battery is charging 3 Patient cable connector Provides connection for patient cable 4 Printer Spirometry FVC report Efforts e All efforts Prints all efforts e Three best efforts Prints the three best efforts of each type that was saved e Only the best effort Prints only the best effort of each type that was saved best FVC FVC pre FVC post Note The printer also provides a printout of patient Auto ECG Stat ECG or Rhythm ECG Directions for use Back view Feature Ethernet connector Clients USB Host USB Power connection AC fuse Ground lug equipotential terminal Battery compartment behind cover Introduction 5 Description Provides a hardwired connection to the computer network The LEDs indicate active network status when the ethernet cable is connected to a network USB type mini B Provides connection to an enabled host USB type A Provides four host USB connections for optional accessories Provides an external AC power connection Provides access to AC fuse Provided for electrical safety testing and as a means for connection of a potential equalization conductor Houses the Li io
3. Multiple flows O Vol L Legend Measured Adjusted Calibration result Syringe volume hk 3000 oo Flow rate Expired volume e 0 5 L s 3029 79 0 ee 3026 25 0 3890 1 0 L s 2973 79 0 87 2992 32 0 26 3 0 L s 2989 79 0 34 2966 75 1 11 Temperature F 78 98 Humidity 42 60 Pressure mmHg 756 44 10 15 IGain 0 97 EGain 1 01 10 Review the results Note Note Check the error percentages for the expired and inspired volumes The 0 5 1 0 and 3 0 L s expired and inspired volumes must be less than 3 5 for the calibration to be acceptable The syringe used to check the volume calibration of spirometers must have an accuracy of 15 mL for a 3 L syringe 11 Touch the Accept button to save the calibration results 26 About calibration CP 150 spirometry option 27 Preparing the patient To prepare patients for any spirometry test explain the entire procedure for the type of effort you want them to perform Remind patients that the test is painless Demonstrate at least one effort for the patient The accuracy of a spirometry test is highly dependent on the patient s understanding and cooperation So be prepared to coach and encourage the patient with your body language and your words for example Blow blow blow keep blowing until you can t blow any more out to ensure a good effort with reproducible results Instruct patients to do the following
4. Trondelag Study Langammer Gulsvik et al European Respiratory Journal 2001 18 770 779 Reference Values for Lung Function Tests in Men Regression Equations With Smoking Variables Hedenstr m et al Upsala Journal of Medicine Science 91 299 310 1986 The Maximal Expiratory Flow Volume Curve Normal Standards Variability and Effects of Age Ronald J Knudson Ronald C Slatin Michael D Lebowitz and Benjamin Burrows et al American Review of Respiratory Disease volume 113 1976 Change in the Normal Expiratory Flow Volume Curve With Growth and Aging Ronald Knudson et al American Review of Respiratory Disease 1983 127 725 734 The Veterans Administration Army Cooperative Study of Pulmonary Function Clinical Spirometry in Normal Men Kory et al American Journal of Medicine February 1961 Spirometric Standards for Healthy Non smoking Adults James F Morris et al American Review of Respiratory Disease volume 103 1971 Spirometric Reference Values from a Sample of the General U S Population John L Hankinson John R Odencrantz and Kathleen B Fedan et al Division of Respiratory Disease Studies National Institute for Occupational Safety and Health Centers for Disease Control and Prevention Morgantown West Virginia 1999 The Third National Health And Nutrition Examination Survey NHANES III Spirometric Reference Values From a Mediterranean Population J Roca J San
5. a Modify the View settings as desired e View Flow Volume View FV curve e View Volume Time View VT curve e View Flow Volume and Volume Time View FV amp VT e View Parameters b Modify the screen settings as desired e Incentive screen e Curves screen When the patient is ready touch the Start post _ button to perform the spirometry test Note Coach the patient through the effort The device stops automatically when air stops moving that is when the ATS end of test criteria are met Optional touch the Stop button when the test has been completed Decide whether to accept the effort Touch the Accept button to save the post test and continue or touch the Reject button If a test is rejected the next post test will increment in number Even if some efforts were deleted the test record indicates the patient s total number of efforts Continue with post test efforts when finished touch the Post test done button to accept the post tests Touch Print to print the test report touch Test results to preview the test report or touch ATS Interpretation to add or edit ATS interpretations Touch Print patient s education to print patient help sheets See About the patient help sheets for further detail Touch Return to post test to continue with FVC post test efforts Touch Done when you have completed the post tests If the Auto Save setting is turned off touch the Yes button and touch Save to save the test Sele
6. 6 FVC and 6 SVC The 6 efforts of a given type can be a mixture of pre medication and post medication efforts Tidal breathing expiration time in seconds See also tidal breathing Multiple breaths normal breathing May be used during FVC or SVC testing After measuring tidal breathing for several seconds the following parameters can be extrapolated MV VE BF and Tin Tex If you combine a VT measurement with a VC measurement you can also calculate the ERV IC and IRV For example COPD patients have a higher ERV and a lower IC and IRV See VT A flow loop that includes all data from all breaths tidal and forced Tidal breathing inspiration time in seconds See also tidal breathing The ratio of Tin and Tex See also Tin and Tex See VT The difference between the best and worst efforts for a parameter FEV1 FVC and so on Pre test and post test variances are reported separately See also best effort Vital capacity See FVC or SVC Ventilation in L min See also tidal breathing See FVC or SVC See volume time Same as volume over time or volume f t A type of data curve available during both FVC and SVC testing The y axis represents liters the x axis represents seconds Tidal volume in liters Also called TV although VT is the preferred abbreviation The volume of air that enters the lungs during inspiration and leaves the lungs during expiration in a normal breathing cycle One of the most important paramet
7. Note Obtain the transducer lot and calibration codes from the transducer package label Note For the syringe volume see the sticker on the calibration syringe Note Humidity Temperature and Pressure are set through the USB spirometer sensor and are not editable fields The temperature must be 10 40 C 50 104 F The atmospheric pressure must be 600 1100 mbar 450 825 mmHg 18 32 inHg 60 110 kPa Touch the amp Next button Connect a new flow transducer to the pressure tubing Attach the flow transducer to the syringe s port as shown in the illustration Push the flow transducer all the way in for a tight seal eg 7 Touch the Continue button Directions for use About calibration 25 CAUTION Several things may affect calibration results movement of the syringe movement of the pressure tubing or blockage of air Place the syringe on a hard level surface with at least 1 cubic meter of open air surrounding the flow transducer Place your hand on top of the syringe to prevent movement 8 Touch the Start button to begin the calibration 9 When the black bar begins to move push the plunger all the way in then pull it all the way out carefully following the black bar s rate Use a steady motion in both directions for 2 more times Touch the Start button to begin each calibration When no air has moved for three seconds the multiple flows results display Spirometer calibration
8. e Height Touch the OK button e Weight Touch the OK button e Smoke Years Touch the OK button e Packs day Touch the OK button e Comments Touch the OK button Touch the D Next button Touch the View or Incentive button to select the display information that you want to view during the test a Modify the View settings as desired e View Flow Volume View FV curve e View Volume Time View VT curve e View Flow Volume and Volume Time View FV amp VT e View Parameters b Modify the screen settings as desired e Incentive screen e Curves screen When the patient is ready touch the Start pre 1 button to perform the spirometry test Note Coach the patient through the effort The device stops automatically when air stops moving that is when the ATS end of test criteria are met Optional touch the Stop button when the test has been completed 10 Decide whether to accept the effort 32 Spirometry tests dul 12 13 CP 150 spirometry option LO Blast out harder Accept Reject Note After each effort a quality message appears on this screen such as Blast out harder Don t hesitate Blow out longer or Good effort Touch the Accept button to save the pre test and continue or touch the Reject button If the test is accepted or rejected the next pre test will increment in number Even if some efforts were deleted the test record indicates the patient s total number of
9. e Loosen any tight articles of clothing that might constrict lung function for example a tight belt tie vest bra girdle or corset e Remove any foreign objects from the mouth including loose dentures Note Use of a nose clip is optional Patients may also pinch their nose e Place your lips and teeth around a new transducer sealing your lips tightly around the transducer Grip slightly with your teeth in the groove If you need to hold the flow transducer in your hand keep fingers away from the screen on the back Blocking even part of this screen creates back pressure which makes the percent prediction value very high as much as 200 or 300 and we will need to discard the data e Avoid bending forward as you blow This also creates back pressure e Keep your tongue away from the flow transducer to avoid blocking it e Keep your chin up so as not to restrict the airway A WARNING Patients may become faint light headed dizzy or short of breath during spirometry testing Watch patients closely If they choose to stand during testing keep a chair immediately behind them If there is any reason for concern stop the test and take proper action A WARNING Patients should not bite on the flow transducer Biting could result in sharp edges which could injure the mouth Note The performance of the spirometer can be affected by the patient spitting or coughing into the spirometer during expiration or by extremes of temperature
10. in liters the maximum volume of air that can be delivered during forced expiration starting from full inspiration Inspiratory capacity in liters The maximum volume of air that can be inhaled after a normal unforced exhalation See also tidal breathing An animated screen that gives patients usually children a goal to achieve while exhaling This screen is listed as a type of curve data display available during FVC testing nspiratory reserve volume in liters The maximum volume that can be inspired from the average end inspiratory level See also tidal breathing Lower limits of normal The lowest expected value for a spirometric parameter The method of determining this value varies from norm to norm See flow loop 62 Glossary lung age maneuver MV NIOSH norm normal OSHA parameter pediatric PEF PIF post test predictive curve predictive points pre test reversibility SVC CP 150 spirometry option A calculated value based on a patient s demographics and spirometric performance that gives a relative indication of the health of the subject s lungs This value is used primarily to encourage smoking cessation Lung age is not available for patients under 20 years of age See effort Minute volume in liters MV BF x VT See also tidal breathing National Institute for Occupational Safety and Health U S A research based spirometry data s
11. 85 or younger the predicted values would be extrapolated values The ratio of these two parameters See FEF50 and FIF50 Forced expiratory flow in L s at 25 of FVC Forced expiratory flow in L s at 50 of FVC Forced expiratory flow in L s at 75 of FVC Forced expiratory flow in L s at 85 of FVC Forced expiratory flow average in L s between 0 2 and 1 2 liters of FVC Forced expiratory flow average in L s during the middle half of FVC Forced expiratory flow average in L s between 75 and 85 of FVC Forced expiratory time in seconds The elapsed time from the beginning of expiration until a specified percentage of FVC Forced expiratory volume in liters at 0 5 seconds Forced expiratory volume in liters at 1 second An important parameter because it reflects the severity of COPD The ratio of these two parameters See FEV1 and FEV6 Forced expiratory volume in liters at 2 seconds Forced expiratory volume in liters at 3 seconds Forced expiratory volume in liters at 5 seconds Forced expiratory volume in liters at 6 seconds FEVO 5 as of FVC Directions for use FEV1 FEV1 formula FEV2 FEV3 FEV5 FEV6 FEVt FIF50 FIV1 FIVC FIVt flow flow f v flow volume flow loop FRC FVC incentive screen IRV LLN loop Glossary 61 FEV1 as of FVC Same as FEV1 FVC A parameter for a single FVC ef
12. If the new effort is better than the worst saved effort the worst effort is deleted and the new one is saved If the new effort is worse than all saved efforts you are asked whether you want to save it If 6 pre efforts have been saved the worst pre effort is deleted when you add a post effort until you have saved 3 pre and 3 post efforts After that the worst post effort is deleted Performing a new Forced Vital Capacity spirometry test A CAUTION Patient data is not saved until the spirometry test is completed Note The spirometry configuration settings can be changed in the Settings tab The following settings may appear differently if the default settings have been modified 1 From the ECG Home screen touch the Spirometry button Note If the Daily Reminder setting is enabled the first time this button is pressed each day the prompt calibrate now appears 2 Touch the Perform new Forced Vitals Capacity test button The Summary tab appears 3 Enter the following patient information Note Required fields are denoted with an asterisk e Patient ID Touch the OK button e Birth date Touch the OK button e Last name Touch the OK button Directions for use 9 Spirometry tests 31 e First name Touch the OK button e Middle Initial Touch the OK button Touch the D Next button Enter the following patient information Note Required fields are denoted with an asterisk e Gender e Race
13. bracket window so that the mini USB cable connector installs correctly during the next steps E ro ES 3 Attach the left side of the spirometer mounting bracket to the device using the second thumb screw Tighten the thumbscrew 12 Setup 4 CP 150 spirometry option Insert the mini USB cable connector into the spirometer sensor mini USB port a Insert the USB cable into the spirometer sensor mounting bracket groove to secure the cable b Insert the USB cable connector into the device s first USB port furthest to the right Note The mounting bracket is designed to protect the spirometer sensor and USB cable and only accepts the USB cable mini connector when the spirometer sensor label faces outward Verify that the spirometer sensor and pressure tubing are clean and undamaged Look for signs of deterioration including but not limited to cracks cuts discoloration or oxidation If any part exhibits any of these symptoms replace it a Attach the pressure tubing to the spirometer sensor b Attach a flow transducer to the pressure tubing CAUTION Hand tighten the spirometer sensor and flow transducer connectors to avoid damaging the connectors The CP 150 software automatically activates the spirometry functions throughout the software Once the software recognizes the sensor the Spirometry button appears in the Content area Directions for use Setup 13 6 Push the flow transducer down onto th
14. efforts Continue with pre test efforts when finished touch the Pre test done button to accept the pre tests Legend i 2 NHANES III 1999 ATS Met 4 Pre Pred 4 Pred FVC 3 61 3 64 FEV1 3 03 3 10 FEV1 84 90 01 FEV6 3 57 0 00 PEF 6 67 7 28 FEF 25 75 3 24 3 50 FEV3 3 50 5 vol L FEVS 3 50 View FV curve o Incentive screen Pre test done Touch Print to print the test report touch Test results to preview the test report on the display or touch ATS Interpretation to add or edit ATS interpretations Touch Print patient s education to print patient help sheets See About the patient help sheets for further detail Touch Start post test to perform post medication efforts for the current patient or touch Return to pre test to continue with FVC pre test efforts Directions for use Spirometry tests 33 Test for Patient NAM F pre test Test results al A ATS Interpretation Print patient s education A a 14 Touch Done when you have completed the pre tests If the Auto Save setting is turned off touch the Yes button and touch Save to save the test Select one of the following locations Local internal memory USB mass storage device Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation Workstation Remote file location Performing a spirometry test using the Search tab A CAUTION Patient data is not saved until the spirometry test i
15. is not well controlled Discuss with your physician medications to better control your asthma ___ Your breathing test shows moderate to severe airways obstruction narrowing of your breathing tubes You are currently unable to blow out air quickly This result usually indicates asthma that is poorly controlled Discuss with your physician very soon the use of medications that will help to better control your asthma and the value of peak flow monitoring Your test shows a low forced vital capacity FVC Your FVC is the total amount of air that you exhaled in liters similar to quarts Values below about 80 are abnormally low and suggest that you are unable to inhale or exhale as much air as most healthy persons of your age height gender and race Obesity may be one of the causes of a mildly decreased FVC and pneumonia is another Consider asking a physician to review this report at some time during the next couple of months Your result FEV1 predicted Your peak flow after inhaling a bronchodilator was L s liters per second You can compare this value to the peak flow that you measure using your own peak flow meter The two numbers should match within 1 L s If your asthma is currently in good control today s value may be close to your best peak flow reading at home Date 50 About the patient help sheets CP 150 spirometry option 51 Predictive Norms etc About Norm extrapolation Extrapolation is the practi
16. lot number differs from the lot number used during the most recent calibration you must recalibrate the spirometer before resuming testing There are two types of calibration Single flow calibration e One inhale exhale cycle Multiple flow calibration e Three inhale exhale cycles at three different rates 3Lin1 second 3 L s 3Lin3 seconds 1 L s 3Lin6 seconds 0 5 L s A CAUTION For proper performance the calibration syringe must be recalibrated every year See the syringe s calibration certificate for the most recent calibration date When the syringe is due for recalibration return it to the manufacturer Performing a calibration Calibrate single flow A CAUTION To avoid the risk of cross contamination always use a new flow transducer when calibrating the spirometer Observe all safety information that came with the flow transducers 1 From the ECG Home screen touch the Spirometry button 2 Touch the Calibrate button The Spirometry calibration screen appears Touch the Calibrate single flow button Fill in these fields e Transducer lot code e Transducer calibration code e Syringe Vol in ml 22 About calibration CP 150 spirometry option Spirometer calibration Transducer lot code Temperature F Pressure mmHg 103 68 759 3 Transducer calibration code mi Expired volume 2MTCXV5D2 3000 00 Insired volume 3000 00 50 Last calibration 12 12 2013 08 00AM mi Sy
17. the operation settings the missing value is filled in from one of the alternative composite norm sources listed here For example since the Crapo norm does not support FEV6 this value is filled in from NHANES III Composite Norm Source Parameters Filled In When Not Supported in Primary Norm NHANES III FVC FEV1 FEV1 FEV6 FEV1 FEV6 PEF FEF25 75 Crapo 1981 FEVO 5 FEV3 FEV3 FVC Morris 1971 FEFO 2 1 2 ECCS Quanjer 1993 FEF25 FEF50 FEF75 The primary norm takes precedence over the composite source For example since the Crapo norm supports the FVC parameter this value always comes from Crapo not from the composite source Composite values are used when the patient does not fit the demographics of either primary norm adult or pediatric For example if the primary norms are Kory and Morris a 14 year old patient fits neither norm due to age restrictions The software would use values from the appropriate composite norms for example NHANES III or ECCS Quanjer 1993 It would not use values from Kory or Morris On the screen and in reports an abbreviation identifies the norm source for each composite value used For example the abbreviation for Roca is ro To enable or disable composite norm values see Viewing or changing the spirometry settings About lung age Lung age is a calculated value based on a patient s demographics and spirometric performance that gives a relative indication of the health of the
18. CP 150 spirometry option Directions for use Software version 2 00 XX WelchAllyn Advancing Frontline Care O 2014 Welch Allyn Inc To support the intended use of the product described in this publication the purchaser of the product is perm Allyn itted to copy this publication for internal distribution only from the media provided by Welch Caution Federal US law restricts sale of the device identified in this manual to or on the order of a licensed physician Welch Allyn assumes no responsibility for any injury or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or indications for use published in this manual Welch Allyn is a registered trademark of Welch Allyn Inc CP 150 and CardioPerfect are trademarks of Welch Allyn Inc Patent information For patent information please visit www welchallyn com patents Software in this product is copyright Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entit ed to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced t
19. Print to print the test report touch Test results to preview the test report or touch ATS Interpretation to add or edit ATS interpretations Touch Return to post test to continue performing post medication efforts for the current patient Test for Patient NAM F Return to pre test Start post test ATS Interpretation Print patient s education 11 Touch Done when you have completed the post tests Directions for use Spirometry tests 37 12 Touch the Yes button and touch Save to save the test Select one of the following locations Local internal memory USB mass storage device Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation Workstation Remote file location Working with a Saved test To view Saved tests 1 From the Spirometry home tab touch the Saved tests tab Search for tests by Date Last name or Patient ID Alternatively you can search for All test types 2 Enter the Date or Patient s Last name or Patient s ID and touch OK Select the Test type 3 Touch the Search button 4 Touch the check box next to the desired test to select the test and then touch the Review button Saved teste dor Barker D Type Faber ED Date rie LZ 0 3 mao VAT Fat Le i E sgr 100 301 3 n ul a 10 20 2013 Fabent name Barker D Racker D Barker D parker D Note Note The Review button is not active until a test i
20. Spirometry home screen Example spirometry report EG Se Se SSE GG A BEEE EE a ee RH ee eRe 95 Boao eee id Caen eee E o G ee n eg zzii ao HE aa G pet S S ERS e el BRE EA S E as ES O e ENET a EA BEG ERRE A PU a J lt A HAG eS ete E ta tee ae ets HHH HREH HHHH E PEEL adem Ri Es Bg AS A en me G EH E Tah RSS ESSE SSE Ss BS 3 ooo oe eee dut EE TTS RRR Ep Foo Jo puig FF FRRRSSERSS Ze REE Re i zat H jE o Aldo eee SSR HH HRE 1H aa E BR Ea EE Hi Sau ua 4 ot SEY GEER EE RRHH 25 ey aaa fail Hat ER yy AO ERE a Hee i ie S WAI AH YE des IH Ep RH RRIT ERER adas C 318 y m Be Bee BER ER ER een ean HHR 207185 O A a HE E LS ae e ee easy oe Heenan S o 4 FIEF A a L TEI an SL aT 13H STTS T TS E T ZD H c En BR Bat Eni fs R La E iak FEEN Hei akel HARE S PET H ie nt de HE Hi a eer Aa LT an er SS E Q noo gt MUERA 3 Ria EG RI 9 oan H I EEE S TTT HE E H Aiii Kan S T T a oa a q Pe gt a He E EE E Bn 1 Gl y EH Sao EER HEE a AAA Ae a Aa EE o Ea Welch Allyn PIN 105353 ys H do 21 About calibration The American Thoracic Society recommends calibrating a spirometer every day before testing In addition each time you open a new package of flow transducers verify the lot number on the package label If this
21. TOWS roreka andado bart 24 Preparing the patenta ais 27 A Sete tees eal aecea e aaia 29 Overview OF the testing process it a eed Gen 29 Performing a new Forced Vital Capacity spirometry Lest 30 CONTINUE Saved TEST 42 cakevtest cxecdesds ao radican 34 Performing a spirometry post teSt oooccocooocccccccoooonnnnnncnnonnnnnnnnncnonon nono nnnnnnononnnos 36 Working witha Saved tes tias balsa led gens 37 Troubleshooting sia tetera Nt nati id aii iii 39 SYMPtOMS and Een TTT 39 Maintenance uns A A 41 Cleaning the spirometer calibration syringe and patient handle 41 Eimited Watios ts 42 SEIVICE PONCY ekana aa tt 42 iv Contents CP 150 spirometry option Specification Sissin ien A A a e eani ETEEN 43 Spirometr y protocols ni 45 About the POP protocol iii E E A E N A E E 45 About the NIOSH protocol deoe a a e aa E T ea A eieaa 45 About the patient help sheets sees eee eee 47 Adult smokers help sheet see 48 Asthma symptoms help Sheet sitiena eaa a aii 49 Predictive Norms OIO ida 51 About Norm extrapolation oooiooiccncncoocooccccnccocococincnonncnnnnnnnnnnnnnnnnnnnnnnnnninnnancanninnns 51 About race ANUN y oda dd 51 About composite Norm values eee 52 About lung age ei ali ee 52 List of Norm related clinical studies ss 54 About quality feedback iniciada 56 Understanding your interpretation results 57 ST a ae a A E hes pede eels 58 Glossa ER PE O E SE ro 59 Introduction About this document This
22. acks day e Age or Birth date e Middle initial e Weight e Comments Touch the Parameters tab Modify the settings as desired Note Select up to eight parameters to display and print Touch the 2 5 Next button to view additional parameters Touch the Spirometry calibration tab Modify the settings as desired e Touch Calibrate single flow e Touch Calibrate multiple flows e Touch Print report e Enable daily reminder CP 150 spirometry option Spirometry home screen Spirometry home screen The Spirometry home screen includes the following areas O 15 12 11 11 2013 Perform new Forced Vital Capacity test Perform post test Change test type lt Spirometer last calibrated on Calibrate 10 20 2013 09 00AM SL c Spirometry home Item Area 1 2 3 Device status Content Navigation Device status area The Device status area located at the top of the Spirometry home screen displays Time and date Battery status Error or information messages These items are displayed until the condition has been resolved 18 Spirometry home screen Content area CP 150 spirometry option The Content area includes 2 test selection buttons a calibrate button and a button to change the test type e Forced Vital Capacity test e Continue saved test e Calibrate e Change test type The content area also provides shortcuts to several controls About the test types FVC Continue s
23. ation Program NLHEP When the PCP protocol is selected the spirometer automatically performs as described here regardless of user defined settings When this protocol is selected testing and reports are affected as follows Operation Settings e Norm NHANES III 1999 Adult e Best Effort Formula Best Measurement e FVC Reversibility formula Post Pre Pre 100 e FEV1 formula FEV6 e ATS interpretation True e Composite norms False e Displaying parameters FEV1 FEV6 FEV1 FEV6 e Efforts to be printed Only best effort e Print lung age True e Print quality grades True About the NIOSH protocol The NIOSH National Institute for Occupational Safety and Health U S protocol is for users who want to make sure that occupational testing and reports meet the requirements of NIOSH The device automatically performs as described here regardless of user defined settings When using this protocol the spirometer should be calibrated at three different flows every day before use 46 Spirometry protocols CP 150 spirometry option When this protocol is selected testing and reports are affected as follows Operation Settings e Norm NHANES III 1999 Adult e Best Effort Formula Best Measurement e Composite norms False e Efforts to be printed Three best efforts 47 About the patient help sheets Two patient help sheets are available to print e Adult smokers If Smoke Years is enabled in the FVC report settin
24. aved test Perform new Forced Vital Capacity test FVC stands for forced vital capacity The goal of an FVC effort is to measure the volume forcefully A test that provides data to compare with pre test data Sometimes called post Rx or post BD bronchodilator A post test must follow a pre test within 24 hours Change test type Auto ECG e A report typically showing a 10 second acquisition of 12 leads of ECG information combined with patient data measurements and optional interpretation Auto ECGs can be saved to the electrocardiograph s test directory or to a USB mass storage device Rhythm ECG e A continuous real time printout of rhythm strips with a user defined lead configuration Rhythm ECGs are printouts only They cannot be saved Stat ECG e An auto ECG that starts without waiting for you to enter patient data Directions for use Spirometry home screen 19 Navigation area The Navigation area includes the following tabs e Spirometry home Displays spirometry test types and provides shortcuts to several controls e Manage worklist Includes patient data entered manually or orders downloaded when connected to a hospital information system e Saved tests Accesses the patient spirometry and ECG tests e Settings Accesses device configuration settings To navigate to a tab touch the tab in the Navigation area with the corresponding name The active tab is highlighted CP 150 spirometry option 20
25. bing Retest using a nose clip Replace the sensor if damaged Recalibrate Replace the transducer and retest 41 Maintenance Cleaning the spirometer calibration syringe and patient handle WARNING Change the flow transducer for each patient WARNING Satisfactory maintenance procedures must be implemented or equipment failure and health hazards may result Only qualified service personnel should repair the equipment CAUTION You cannot clean the spirometer or any of its components CAUTION Do not clean the pressure tubing or sensor Trapped moisture could affect accuracy CAUTION Replace the pressure tubing when it becomes dirty Recalibrate after replacement gt ee BB CAUTION Replace the sensor when it becomes faulty D Cleaning the calibration syringe Wipe the outer surface of the calibration syringe with a clean cloth slightly dampened with 70 percent isopropyl alcohol Cleaning the patient handle A WARNING Keep the patient handle clean Patient contact with contaminated equipment can spread infection Note Clean the patient handle after each patient use Clean on a routine basis according to your facility s protocols and standards or local regulations The following agents are compatible with the patient handle e 70 percent isopropyl alcohol e 10 percent chlorine bleach solution 42 Maintenance CP 150 spirometry option A CAUTION When cleaning the patient handle avoid using cl
26. ce of applying a norm s formula to a patient who doesn t fit that norm s demographics For example if you were testing an 88 year old man and the primary selected norm was based on males 85 or younger the predicted values would be extrapolated values e Norm extrapolation is indicated in the test record e Adult norms allow extrapolation of age up but not down e Adult norms allow extrapolation of height weight and smoke years up and down About race adjustment Although expected values for certain parameters vary significantly between ethnic groups some norm studies do not include separate regression equations for different races For those studies the following table describes the adjustments made by the CP 150 software for the FVC and FEV1 predicted values Where applicable norm values are multiplied by the percentages identified in the following table Race Choices FVC amp FEV1 Recommendation Source Caucasian No adjustment Black 88 ATS Asian 94 NIOSH Hispanic No adjustment None found Native American 94 NIOSH Polynesian 94 NIOSH Aboriginal 94 NIOSH Indian 94 NIOSH Note Race adjustment applies for adults only If a race adjustment percentage is used the same adjustment is applied to the LLN value 52 Predictive Norms etc CP 150 spirometry option About composite Norm values When the primary selected norm does not support a given parameter and when composite norm values are enabled in
27. chis et al Bulletin Europ en de Physiopathologie Respiratoire 1986 22 217 224 Growth and Decay of Pulmonary Function in Healthy Blacks and Whites Janet B Schoenberg Gerald J Beck and Arend Bouhuys et al Respiration Physiology 1978 33 367 393 Directions for use Predictive Norms etc 55 Norm Clinical Study Viljanen 1981 Spirometric Studies in Non smoking Healthy Adults Viljanen et al Journal of Clinical Lab Investigation 41 supplement 159 5 20 1981 56 Predictive Norms etc CP 150 spirometry option About quality feedback The spirometer provides two kinds of quality feedback effort quality messages and test quality grades as described in the following sections About effort quality messages One of the following effort quality messages appears on the screen after each effort is completed These messages indicate whether an effort was acceptable and reproducible and if not what the patient needs to do differently The term match here means variation or difference with respect to best test Effort quality message Criteria Don t hesitate Back extrapolated volume gt 150 ml or 5 whichever is greater Blast out faster PEF time gt 120 ms Blow out longer FET lt 6 0 seconds and end of test volume gt 100 ml invalid FEV6 Blast out harder PEF is not reproducible match gt 1 0 L s Deeper breath FEV6 match gt 150 ml FVC may be substituted for FEV6 Good effo
28. ct one of the following locations 36 Spirometry tests CP 150 spirometry option e Local internal memory e USB mass storage device Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation e Workstation e Remote file location Performing a spirometry post test Complete the pre test efforts See Performing a new Forced Vital Capacity spirometry test Note Pre and post efforts must happen on the same day The next day tests 1 Pe o No 9 become available for review only you can no longer add efforts to them Touch the Continue saved test button The Spirometry saved tests screen appears Select a patient from the list of saved tests Touch the Patient ID Patient name Birth date or Efforts Touch the Continue test button When the patient is ready touch the Start post _ button Note Coach the patient through the effort The device stops automatically when air stops moving that is when the ATS end of test criteria are met Optional Touch the Stop button when the test has completed Decide whether to accept the effort Touch the Accept button to save the post test and continue or touch the Reject button If a test is accepted or rejected the next post test will increment in number Even if some efforts were deleted the test record indicates the patient s total number of efforts Touch Post test done to accept the post test 10 Touch
29. e patient handle until it is secure A WARNING Keep the reusable patient handle clean Patient contact with contaminated equipment can spread infection Note Clean the patient handle after each patient use 14 Setup CP 150 spirometry option Settings Viewing or changing the spirometry settings e The spirometry settings control the predictive norms parameters formulas and content of your report To view or change the settings 1 Touch the Settings tab The ECG tab and the vertical ECG configuration tab appear 2 Touch the Spirometry tab The vertical Spirometry configuration tab appears Modify the settings as desired Note The following settings are saved as they are selected e Protocol e Predictive norm e Incentive options e Best effort formula e FVC reversibility formula Touch the a Next button Modify the settings as desired e FEV1 formula e Printer o Internal o PDF to USB o PDF to remote file location o Internal and PDF to USB o Internal and PDF to remote file location e Enable ATS interpretation e Composite norm values Touch the a Next button Modify the settings as desired e Temperature unit 16 Settings e Pressure unit e Flow unit Touch the FVC report tab Modify the settings as desired e Efforts e Lung age e Quality grades e Print ATS Reproducibility Not Met Touch the Ue Next button Modify the settings as desired e First name e Smoke years e P
30. ems are FVC and FEV1 For a description of how the automatic interpretation software uses these two measurements to determine the degree of obstruction or restriction see Understanding Your Interpretation Results e FVC forced vital capacity the maximum volume of air that can be forcibly and rapidly exhaled 30 Spirometry tests CP 150 spirometry option e FEV1 forced expiratory volume 1 the volume of air that is exhaled at one second of a forced expiration About pre and post testing If desired a spirometry test may include both pre and post efforts to measure the effectiveness of medication The before medication and after medication efforts may be uninterrupted or interrupted e Uninterrupted If there is no interruption between pre and post efforts that is no other patient has been tested and the device has remained on the same screen continues to display You simply continue with the procedure e Interrupted If there is an interruption that is another patient has been tested or the device has been turned off you need to recall the patient s test in progress before continuing Note Pre and post efforts must happen on the same day The next day tests become available for review only you can no longer add efforts to them About effort replacement You can save up to 6 FVC efforts per test After saving 6 efforts of a given type the software compares each new effort with the saved efforts
31. ers in SVC testing See also MV tidal breathing and tidal volume curve See CardioPerfect workstation WelchAllyn Advancing Frontline Care HII 720167
32. et with a specific profile for race gender age and height The software compares each patient s results with data in the primary selected norm reporting the results as percentages of the predicted normal values Consistent with norm data Occupational Safety amp Health Administration U S A commonly defined attribute of a spirometric waveform FVC FEV1 and so on Generally under 18 years old Age limits vary with each norm Also young children s lung sizes vary greatly Norm values and interpretive results are not available for patients under 3 years of age Peak expiratory flow in L s The largest expiratory flow achieved with a forced effort Peak inspiratory flow in L s The largest inspiratory flow achieved with a forced effort A test that provides data to compare with pre test data Sometimes called post Rx or post BD bronchodilator A post test must follow a pre test within 24 hours See also reversibility A curve that follows a set of predictive points Key values from the selected norm and from composite norms if enabled Applicable for FVC tests only For flow volume curves predictive values are PEF FEF25 FEF50 FEF75 and FVC all represented as points For volume time curves predictive values are FEV represented as a point and FVC represented as a horizontal line If predictive points are enabled all available predictive values appear on the screen and the printout A test that pr
33. fort A user selectable formula that determines the calculation method for a test s not an effort s overall FEV1 value which affects the automatic interpretation FEV2 as of FVC FEV3 as of FVC FEV5 as of FVC FEV6 as of FVC Timed forced expiratory volume in liters Volume of air exhaled in the specified time during an FVC effort Forced inspiratory flow in L s at 50 of FIVC FIV1 as of FIVC Forced inspiratory vital capacity in liters The maximum volume of air that can be inspired during forced inspiration starting from full expiration Timed forced inspiratory volume in liters Volume of air inhaled in the specified time t The speed at which air is inhaled or exhaled in L s See flow volume Same as flow over volume or flow f V A type of data curve available during FVC testing The y axis represents flow L s the x axis represents volume liters A flow volume curve that includes inspiratory data negative values on the y axis Functional residual capacity in liters Volume of air remaining in the lungs and airway at the average end expiratory level Forced vital capacity 1 A type of test in which patients inhale fully and exhale forcefully for as long as they can The goal to measure the volume and flow of air May or may not include forced inhaling When forced inhaling is included it may be done either before or after exhaling See also flow loop 2 An important parameter
34. gs the Smokers education sheet option can be printed for adult smokers e Asthma symptoms These help sheets print only if patient education is selected To enable patient education touch the Print patient s education button after the FVC efforts have been performed Touch the checkbox next to Asthma education or Smokers education Print Patient Educaton Select education materials to print J Ashtma education Smokers education The patient s name FEV1 predicted and date print automatically on both sheets If Enable ATS Interpretation is selected the appropriate recommendation is also marked To enable ATS Interpretation touch the Settings tab The ECG tab and the vertical ECG configuration tab appear Touch the Spirometry tab The vertical Spirometry configuration tab appears Touch the LA Next button Touch the checkbox next to the Enable ATS Interpretive Note If no recommendation is marked the doctor must mark one Both help sheets come from a booklet entitled Simple Office Spirometry for Primary Care Practitioners by Thomas L Petty MD and Paul L Enright MD This booklet can be downloaded from the National Lung Health Education Program NLHEP home page http www nlhep org Pages Resources aspx 48 About the patient help sheets CP 150 spirometry option Adult smokers help sheet Name What Your Lung Function Results Mean For Adult Smokers You have just performed Spirometry the basic test of how we
35. heric air pressure limits CP 150 spirometry option Specification Volume time curve Flow volume curve Both volume time and displayed curves No curves None FVC FIVC FIV1 FIV1 FEVO 5 FEV1 FEV2 FEV3 FEV5 FEV6 FEV1 FEV6 FEVO 5 FEV1 FEV2 FEV3 FEV5 FEV6 PEF FEF25 FEF50 FEF75 FEFO 2 1 2 FEF25 75 FEF75 85 PIF FIF50 FEF50 FIF50 FET Effort acceptability and test reproducibility checks Effort quality messages and test quality grades Visual incentive for assistance in coaching patients Compatible with CardioPerfect workstation IPXO IP20 PCP primary care practitioner NIOSH None 10 C to 40 C 50 F to 104 F 15 95 noncondensing 30 70 for printing 700 1060 hPa 20 C to 50 C 4 F to 122 F 15 95 noncondensing 700 1060 hPa Specifications are subject to change without notice 45 Spirometry protocols This manual describes the protocols you can select to change the way the CP 150 spirometer operates when testing a patient Any features that are not specified in the protocol use your own settings Protocol settings are uneditable after selection to avoid confusion during setup To learn how to review or change the protocol see Viewing or changing the spirometry settings Aboutthe PCP protocol The PCP primary care practitioner protocol is for users who want to make sure that testing meets the requirement of the National Lung Health Educ
36. humidity and altitude 28 Preparing the patient CP 150 spirometry option 29 Spirometry tests Overview of the testing process A single test comprises a set of efforts up to 6 FVC efforts The 6 efforts of a given type can be a mixture of pre and post medication efforts About FVC efforts FVC stands for forced vital capacity The goal of an FVC effort is to measure the volume and flow of air Patients inhale fully then exhale forcefully Sometimes they also inhale forcefully When ready to begin an FVC effort you coach the patient through these steps If preferred you may reverse the order of inhaling and exhaling 1 Inhale fully calmly fill your lungs as much as you can 2 Place the flow transducer in your mouth 3 Exhale forcefully as fast as you can as long as you can 4 Optional Inhale forcefully as fast as you can as long as you can During FVC testing an optional animated incentive screen provides an alternative way to view the data This screen gives patients a goal to achieve while exhaling Touch the Settings tab Touch the Spirometry tab Select one of the animation Incentive options from drop down menu e Fireman e Frog e Dandelion e Birthday About the spirometry parameters During FVC testing many parameters are measured and calculated For definitions of these parameters see the Glossary During FVC testing the two most important parameters in determining lung probl
37. ides expected values for various spirometric parameters by measuring significant samples of a particular population Norm Berglund 1963 Crapo 1981 ECCS Quanjer 1993 Falaschetti 2004 Forche Il Gore 1995 Gulsvik 2001 Hedenstr m 1986 Knudson 1976 Knudson 1983 Kory 1961 Morris 1971 NHANES III Roca 1986 Schoenberg 1978 Clinical Study Reference Spirometric Studies in Normal Subjects Forced Expiratograms in Subjects 7 70 Years of Age Berglund et al Acta Medica Scandinavica volume 173 1963 Reference Spirometric Values using Techniques and Equipment that Meet ATS Recommendations Crapo et al American Review of Respiratory Disease 1981 123 659 664 Lung Volumes and Forced Ventilatory Flows Official Statement of the European Respiratory Society Quanjer et al 1993 European Respiratory Journal 1993 supplement 16 5 40 Prediction equations for normal and low lung function from the Health Survey for England E Falaschetti J Laiho P Primatesta S Purdon European Respiratory Journal 2004 23 456 463 Equations acquired from the Spirometry Norm Study from Dr Giinter Forche Prim Univ Doz Spirometric standards for healthy adult lifetime nonsmokers in Australia C J Gore A J Crockett D G Pederson M L Booth A Bauman N Owen European Respiratory Journal 1995 8 773 782 Forced Spirometry Reference Values for Norwegian Adults The Bronchial Obstruction in Nord
38. ling and medical records A value that is filled in from another norm a composite norm source when the primary selected norm does not support a given parameter Applicable only when composite norm values are enabled 60 Glossary COPD curve effort ERS ERV extrapolation FEF50 FIF50 FEF25 FEF50 FEF75 FEF85 FEFO 2 1 2 FEF25 75 FEF75 85 late FEF FET FEVO 5 FEV1 FEV1 FEV6 FEV2 FEV3 FEV5 FEV6 FEV0 5 CP 150 spirometry option Chronic obstructive pulmonary disease Characterized by airflow obstruction that is primarily caused by smoking Examples include emphysema chronic bronchitis and asthmatic bronchitis A graphical display of spirometry data During SVC testing only one curve type is available volume time During FVC testing four curve types are available volume time flow volume tidal volume and on screen only incentive A single spirometry maneuver for example one blow A single test comprises multiple efforts See also best effort European Respiratory Society Expiratory reserve volume in liters The maximum volume that can be expired from the level of the functional residual capacity FRC See also tidal breathing The practice of applying a norm s formula to a patient who doesn t fit that norm s demographics For example if you were testing an 88 year old man and the primary selected norm were based on males
39. ll your lungs are working The results indicate whether you have developed chronic obstructive pulmonary disease COPD due to smoking COPD occurs in about one of every five smokers after more than 20 years of smoking COPD slowly eats away at the lung s reserves Affected smokers are often unaware of lung disease until more than half of their lung function has been lost Spirometry testing can detect COPD many years before symptoms occur Your test result was within the normal range You do not appear to be developing COPD However as a smoker you remain at high risk of developing a heart attack stroke and or lung cancer Call the number at the bottom of this page for help with smoking cessation ___ Your test result shows mild airways obstruction suggesting that you are a susceptible smoker who already shows signs of early COPD You are unable to blow out air as quickly as normal your FEV1 FVC is low If you continue smoking you will eventually develop disabling lung disease in about 10 20 years If you are able to successfully quit smoking sometime soon your lung function may return to normal levels and you will probably never develop symptoms of COPD Call the number at the bottom of this page if you would like information about local resources to help you quit smoking Your test result shows moderate to severe airways obstruction You have COPD If you continue smoking your lung disease will certainly get worse and yo
40. manual is written for clinical professionals performing pulmonary function testing Users must be familiar with measurements and the clinical significance of basic spirometry products Before using the spirometer all users and technicians must read and understand this manual and all other information accompanying the CP 150 spirometry option and the CP 150 electrocardiograph Caregivers need to know how to properly coach patients to recognize acceptable waveforms and to know whether results meet ATS reproducibility criteria The hospital s Biomedical IT support staff shall require primary skills including disciplines related to maintenance and servicing computer controls platforms It is recommended that users attend a certified spirometry training course The instructions given here are only a guide and should not be used to train a technician Note This manual supplements the CP 150 electrocardiograph manual entitled CP 150 12 lead resting electrocardiograph Directions for use See the electrocardiograph manual for procedures that are common to both ECG and spirometry functions such as how to move through the menus or how to search for patient data Intended use The CP 150 spirometry option allows the user to acquire view store and print measures and waveforms of pulmonary function including but not limited to maximal volume and flow of air that can be moved in and out of a patient s lungs These measures are used in the diagno
41. moved for three seconds Spirometer calibration po Legend Single flow Measured Adjusted 10 Time s Calibration result Syringe volume ml 3000 00 Expired volume ml 3000 94 0 03 Inspired volume ml 2991 78 0 28 Temperature F 77 02 Humidity 50 80 Pressure mmHg 756 81 IGain 0 96 EGain 1 02 10 Review the results Note Check the error percentages for the expired and inspired volumes Both volumes must be less than 3 5 for the calibration to be acceptable For single flow calibrations the measured and adjusted curves should match Note The syringe used to check the volume calibration of spirometers must have an accuracy of 15 mL for a 3 L syringe 11 Touch the Accept button to save the calibration results 23 24 About calibration CP 150 spirometry option Calibrate multiple flows 1 From the ECG Home screen touch the Spirometry button 2 Touch the Calibrate button The Spirometry calibration screen appears Touch the Calibrate multiple flows button Fill in these fields e Transducer lot code e Transducer calibration code e Syringe Vol in ml Spirometer calibration ls Transducer lot code Temperature F Pressure mmHg 103 68 759 3 Transducer calibration code Expired volume ml 2MTCXV5D2 3000 00 Insired vol Syringe vol ml Humidity ds OLA 3000 00 50 Last calibration 12 12 2013 08 00AM
42. n The Summary tab appears Touch the Worklist tab The worklist is downloaded from the EMR Touch the Order ID Patient ID Patient name or Birth date to select the patient from the Worklist e Touch the Select button e Touch the amp Next button to review or edit patient information e Touch the amp Next button again Touch the View or Incentive button to select the display information that you want to view during the test When the patient is ready touch the Start pre 1 button to perform the spirometry test Note See Performing a new Forced Vital Capacity spirometry test for additional details Continue saved test A CAUTION Patient data is not saved until the spirometry test is completed Note The spirometry configuration settings can be changed in the Settings tab 1 The following settings may appear differently if the default settings have been modified From the Spirometry home screen touch the Continue saved test button The Spirometry saved tests screen appears Directions for use 10 T1 Spirometry tests 35 Spirometry saved tests 10 10 2013 Date of birth v 55459001 07 11 1954 234890 09 05 1949 889902 03 02 1961 Continue test Select a patient from the list of saved tests Touch Patient ID Patient name Birth date or Efforts Touch the Continue test button Touch the View or Incentive button to select the display information that you want to view during the test
43. n battery 6 Introduction CP 150 spirometry option Spirometry option back view f No Feature Description 1 Bracket Spirometer sensor mounting bracket 2 Thumb screws Thumb screws to attach bracket to device 3 USB cable Provides spirometer sensor connection to device 4 Spirometer sensor USB spirometer sensor 5 Disposable flow transducers Measures patient air velocity Connects to pressure tubing 6 Pressure tubing Connects flow transducer to USB spirometer sensor 7 Patient handle Holds flow transducer and pressure tubing Directions for use Symbols Documentation symbols A 7d welchallyn com WARNING The warning statements in this manual identify conditions or practices that could lead to illness injury or death Consult Directions for Use Electronic version available at Welchallyn com or Hard copy DFU available from Welch Allyn within 7 days Shipping storing and environment symbols 1 y 122F 50 C es 4F 20 C Lt x Li ion This end up Fragile Temperature limits Separate the battery from other disposables for recycling Separate the device from other disposables for recycling See www welchallyn com weee Lithium ion battery Introduction Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property or loss of data This definition applies to both yellow and black and white symbol
44. ning a diagnosis However the data should not be used as a sole means for determining a patient s diagnosis WARNING To minimize the chance of a misdiagnosis it is the physician s responsibility to assure that spirometry tests are properly administered evaluated and interpreted WARNING To prevent the spread of infection do not try to clean the flow transducers and nose clips Discard these items after a single patient use WARNING Keep the reusable patient handle clean Patient contact with contaminated equipment can spread infection Directions for use A Introduction 9 WARNING Read and observe all safety information provided in the flow transducer instructions General cautions The following caution statements apply to spirometer use in general Caution statements that apply specifically to particular procedures appear in the corresponding sections of the manual Cautions indicate conditions or practices that could damage the equipment or other property A gt Pe BP BPP CAUTION Do not clean the spirometer or any of its components Trapped moisture in the pressure tubing or sensor could affect their accuracy Replace the pressure tubing when it becomes dirty Replace the sensor when it becomes faulty Recalibrate the spirometer after replacing any components CAUTION Do not immerse any part of the spirometer into a cleaning liquid or sterilize it with hot water steam or air CAUTION Do not use aromatic h
45. o human perceivable form This is not a sale of the software or any copy of the software all right ti tle and ownership of the software remains with Welch Allyn or its vendors Welch Allyn Technical Support http www welcha 105661 CD DIR 80018004 Ver F eel Welch Allyn Inc 4341 State Street Road lyn com about company locations htm Material Number 720167 DIR 80018004 Ver F Ec mer Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Skaneateles Falls NY 13153 0220 U S A Dublin Road www welchallyn com Navan County Meath Republic of Ireland WelchAllyn Advancing Frontline Care Contents INTO CUGUION saree id 1 ABOUETNIS DOCU e talleres alge pet a aeai aene eoliana 1 Intended USO O OPA E E a eka Seay a cae eens eee 1 INGICATIONS TORUS ii cto 2 Conrandea ONS zorakan sista A ida 2 Descrip edhi e ta o a NRA e E 2 ESTOS it A AA 2 Controls Indicators and CONNECTONS escoria ta ida a Tota au 4 Symbol aii 7 General W FQINOS malito dra dia 8 A O 9 O Saket Git an cela ela etal Beth Seta Bel Gh Geta Beta bean es 11 Connecting the Spirometer minis dr dde ita cl i 11 DOLUNGS crcr tinan eeeeae eect areca cenouLerceacseaee outa ca 15 Viewing or changing the spirometry Settings 15 Spirometry NOME screen esse eee eee eee eee 17 SPIFOMELY home Ns A 17 About calibration A Dic aan ri erat ib elencos 21 Performingra callbra ON tias i 21 Calibrate MUlti Pl
46. oths or solutions that include quaternary ammonium compounds ammonium chlorides or glutaraldehyde based disinfectants Note Disinfect according to your facility s protocols and standards or local regulations Limited warranty For general information on the limited warranty see the electrocardiograph manual entitled CP 150 12 lead resting electrocardiograph Directions for use The following spirometry components have specific warranty periods from date of shipment to customer e Sensor 12 months e Calibration syringe 12 months Service policy For general information on the service policy see the electrocardiograph manual entitled CP 150 12 lead resting electrocardiograph Directions for use The following spirometry components have specific service policies For disposable items see the Approved Accessories Flow transducer Disposable Pressure tubing Disposable Sensor Return to Welch Allyn for replacement if necessary Replacement is free within the warranty period Syringe Return to the manufacturer for calibration verification if necessary Recalibration is free within the warranty period Beyond the warranty period return to the manufacturer AM Systems Inc 131 Business Park Loop Carlsborg WA 98324 800 426 1306 Specifications 43 Item Dimensions and weights Flow transducer Pressure tubing Sensor Tests Flow technology Power equipment Current consumption Acc
47. oughs 2 Criteria ensuring that the patient has made at least two efforts of the same kind two FVC pre or two FVC post and that these efforts are reproducible Spirometry 2005 Update ATS ERS task force This document describes the methods of acquiring the output parameters and the required accuracy For details on ATS ERS acceptability criteria see these sections in the standard e Start of Test Criteria page 324 For details see document Standardisation o e Manoeuvre repeatability page 325 The software generates interpretive results as described in Lung Function Testing Selection of Reference Values and Interpretive Results American Thoracic Society March 1991 This document describes the methods of selecting the reference values and the algorithm for interpretative results See pre test A measurement calculated from a set of efforts The formula for calculating best effort is userselectable 1 the single best effort or 2 a composite of best parameter values Breathing frequency See also MV and tidal breathing See post test Body conditions normal body temperature 37 C ambient pressure saturated with water vapor The BTPS correction factor converts ambient conditions temperature humidity and pressure to BTPS APC using Welch Allyn CardioPerfect software Stores ECG and spirometry test data Can communicate with other electronic patient information systems such as bil
48. ovides a baseline for comparison with a post test taken by the same patient Sometimes called pre Rx or pre BD bronchodilator Pre tests and post tests are commonly used to evaluate the effectiveness of medication See also reversibility The percentage difference between pre test and post test data This measurement indicates the effect of medication on lung function Reversibility applies to each parameter separately The reversibility formula which determines the way in which reversibility is calculated is user selectable Slow relaxed vital capacity 1 A type of test in which patients breathe normally several times then inhale maximally and exhale maximally or vice versa Sometimes SVC testing is used when forced breathing is impossible The patient inhales and exhales as completely as possible as in FVC testing but the breathing is not forced The goal of an SVC effort is to measure the volume of air inhaled and exhaled not the air flow speed 2 An important parameter in liters the maximum volume of air exhaled from the point of maximum inhalation or maximum volume of air inhaled from a point of maximum exhalation Directions for use test Tex tidal breathing tidal volume tidal volume curve Tin Tin Tex TV variance ve VE vital capacity volume f t volume time workstation Glossary 63 A set of efforts up to 6 efforts of each type FVC and SVC for a maximum of 12 efforts
49. ringe vol ml Humidity 3000 00 Note Obtain the transducer lot and calibration codes from the transducer package label Note For the syringe volume see the sticker on the calibration syringe Note Humidity Temperature and Pressure are set through the USB spirometer sensor and are not editable fields The temperature must be 10 40 C 50 104 F The atmospheric pressure must be 600 1100 mbar 450 825 mmHg 18 32 inHg 60 110 kPa Touch the 33 Next button Connect a new flow transducer to the pressure tubing Attach the flow transducer to the syringe s port as shown in the illustration Push the flow transducer all the way in for a tight seal tet Touch the Continue button A CAUTION Several things may affect calibration results movement of the syringe movement of the pressure tubing or blockage of air Place the syringe on a hard level surface with at least 1 cubic meter of open air surrounding the flow transducer Place your hand on top of the syringe to prevent movement Touch the Start button to begin the calibration When the black bar begins to move push the plunger all the way in then pull it all the way out carefully following the black bar s rate Use a steady motion in both directions Directions for use About calibration Push the plunger try to follow the target rate Target Rate Actual Rate The results display for a single flow calibration after no air has
50. rt Effort meets above criteria Good test session Two acceptable efforts match About test quality grades Another type of feedback is the test quality grade as described in the following table If Quality grades is enabled in the FVC report settings a grade appears on printed reports and also displays on screen when you view the values or interpretation of a completed test To enable or disable this setting see Viewing or changing the spirometry settings Test Number of acceptable efforts Reproducibility quality grade A 2 or more Largest two FEV1 values match lt 100 mL Largest two FVC values match lt 100 mL B 2 or more Largest two FEV1 values match gt 100 and lt 150 mL C 2 or more Largest two FEV1 values match gt 150 and lt 200 mL D 1 or more Largest two FEV1 values match gt 200 mL F None Directions for use Understanding your interpretation results Predictive Norms etc 57 This diagram shows how the automatic interpretation software uses a patient s FVC and FEV1 results in comparison with normal values to determine the degree of obstruction or restriction This diagram follows the American Thoracic Society s example for interpretation May be a yes Physiological Variant Mild yes T Obstruction Moderate w Obstruction Moderately yes Severe Obstruction Severe ye
51. s Meets essential requirements of European Medical Device Directive 93 42 EEC Keep dry Relative humidity limit Atmospheric air pressure limits Recycle China RoHS restriction of hazardous substances symbols for control of pollution caused by electronic information products 5 year environment friendly use period EFUP 7 for batteries 10 year EFUP for the device For details see the accompanying documentation Keep away from sunlight 8 Introduction CP 150 spirometry option Expiration date 20XX XX 1P20 Protected against the ingress of solid foreign objects gt 12 5 mm diameter not protected against the ingress of water Miscellaneous symbols Manufacturer Type BF applied part gt Reference Model number Serial number Reorder Catalog number Batch code Professional use only Do not reuse 9 8 E Conforms with IEC UL CSA EN 60601 1 Intertek ETL listed General warnings The following warning statements apply to spirometer use in general Warning statements that apply specifically to particular procedures such as preparing the patient for testing appear in the corresponding sections of the manual Warnings indicate conditions or practices that could lead to illness injury or death A gt gt D WARNING The spirometer captures and presents data reflecting a patient s physiological condition When reviewed by a trained physician or clinician this data can be useful in determi
52. s Obstruction Very Severe yes Obstruction REPEAT MANEUVER S NORMAL SPIROMETRY Mild RESTRICTION 70 Restriction Moderate yes 0 Restriction Moderately Severe 4 0 Restriction Severe Restriction Very Severe Restriction FVC Below 80 of predicted li yes y And low vital capacity cannot rule out superimposed restriction yes o 60 lt FVC lt 70 50 lt FVC lt 60 of Predicted 34 lt FVC lt 50 of Predicted FVC lt 34 s FVC lt LLN Predicted Predicted Predicted 58 Predictive Norms etc CP 150 spirometry option References 1 2 Checklist for Compliance with NLHEP Guidelines for Office Spirometers National Lung Health Education Program www nlhep org resources html review Disability Evaluation Under Social Security the blue book Social Security Administration SSA publication number 64 039 Office of Disability Programs ICN 468600 January 2003 See in particular the calibration and reporting sections of this document Lung Function Testing Selection of Reference Values and Interpretive Results American Thoracic Society March 1991 This document describes the methods of selecting the reference values and the algorithm for interpretative results National Occupational Respiratory Mortality System Na
53. s completed Note The spirometry configuration settings can be changed in the Settings tab The following settings may appear differently if the default settings have been modified 1 Touch the Perform new Forced Vital Capacity button The Summary tab appears 2 Search for patient The Search tab gives you access to patient data in the Saved tests directory or in a connected database CardioPerfect workstation or EMR Touch the Search tab Enter the Patient ID or Last name Touch the OK button Touch the Search button Touch the Patient name Patient ID or Birth date in the Patient name Patient ID field Touch the Select button Touch the 323 Next button to review or edit patient information Touch the D Next button again 3 Touch the View or Incentive button to select the display information that you want to view during the test 34 Spirometry tests CP 150 spirometry option 4 When the patient is ready touch the Start pre 1 button to perform the spirometry test Note See Performing a new Forced Vital Capacity spirometry test for additional details Performing a spirometry test using the Worklist tab A CAUTION Patient data is not saved until the spirometry test is completed Note The spirometry configuration settings can be changed in the Settings tab The following settings may appear differently if the default settings have been modified Touch the Perform new Forced Vital Capacity butto
54. s selected Only a single spirometry test can be reviewed at a time Spirometry tests are denoted with a ky icon in the Test type column 38 Spirometry tests CP 150 spirometry option NAM F 11 11 2013 y 1 2 CI co ms Flow L s Vol L Legend 1 2 4 5 Post 5 5 Vol L 0 Time sec K D View and Print options include test efforts with color coded legend parameters with norm profile efforts summary and ATS Interpretive results Troubleshooting 39 Symptoms and solutions Problem solving suggestions If you try these suggestions and still have problems contact Welch Allyn Symptom Possible cause Unable to calibrate Poor connection between flow transducer and sensor Damage to flow transducer Leak during calibration Uneven calibration strokes Pressure tubing is kinked No sensor detected Poor connection between the sensor and the device Does not print Out of paper Paper jam Values are too high intermittent Patient s fingers obstructed the screen on the back of the flow transducer causing high back pressure and false reading Patient s lips were not tightly sealed around the flow transducer Spirometer was calibrated with the wrong size syringe Suggested action Check the connection between flow ransducer and sensor Replace the flow transducer if it is damaged Ensure that the connection between he calibration syringe and flow ransducer is tight with no leaks
55. sis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with patients who are able to understand the instructions for performing the test 2 Introduction CP 150 spirometry option Indications for use The spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening These measurements provide information about a patient s pulmonary function which may be compared with normal values or the patient s previous values The device is designed to test pulmonary function and obtain spirometric indices for adult and pediatric patients 12 years and older hospital and clinic use only Contraindications Relative contraindications to performing spirometry hemoptysis of unknown origin forced expiratory maneuver may aggravate the underlying condition pneumothorax unstable cardiovascular status forced expiratory maneuver may worsen angina or cause changes in blood pressure or recent myocardial infarction or pulmonary embolus thoracic abdominal or cerebral aneurysms danger of rupture due to increased thoracic pressure presence of an acute disease process that might interfere with test performance e g nausea vomiting recent eye for example cataract thoracic and abdominal surgery chest and abdominal pain Description Features The CP150 is a 12 lead diagnostic ECG device with a spirome
56. subject s lungs This value is used primarily to encourage smoking cessation The CP 150 spirometer calculates lung age values according to the document Short Report Spirometric Lung Age Estimation for Motivating Smoking Cessation Morris 1995 For single effort tests lung age is based on the current effort Otherwise it is based on the patients best effort as defined in the settings Lung age results less than 20 years are reported as lt 20 and results greater than 84 are reported as gt 84 This limitation is derived from the subject population on which Morris based his research Lung age which is expressed in years is the average of the four formulas in the Morris article FVC FEV1 FEF25 75 and FEFO 2 1 2 Specifically lung age is calculated as follows Gender Lung Age Formula Men 5 920 height 40 000 FVC 169 640 Directions for use Gender Women Predictive Norms etc 53 Lung Age Formula 2 870 heigh 2 319 heigh 1 044 heigh 4 792 heigh 3 560 heigh 4 028 heigh 2 000 heigh 31 250 FEV1 39 375 21 277 FEF200 1200 42 766 22 222 FEF25 75 55 844 4 t 41 667 FVC 118 833 40 000 FEV1 77 280 27 778 FEF200 1200 70 333 33 333 FEF25 75 18 367 4 54 Predictive Norms etc CP 150 spirometry option List of Norm related clinical studies Each of the following studies prov
57. tional Institute for Occupational Safety and Health NIOSH Short Report Spirometric Lung Age Estimation for Motivating Smoking Cessation James F Morris M D and William Temple Preventive Medicine 14 655 662 1985 Standardisation of Spirometry 2005 Update ATS ERS task force This document describes the methods of acquiring the output parameters and the required accuracy For details on ATS ERS acceptability criteria see these sections in the standard e Start of Test Criteria page 324 e Manoeuvre repeatability page 325 Standardized Lung Function Testing European Respiratory Journal volume 6 supplement 16 March 1993 U S Pulmonary Function Standards for Cotton Dust Standard 29 CFR 1910 1043 Appendix D Lung Function Testing Selection of reference values and interpretive strategies American Thoracic Society American Review of Respiratory Disease 144 1202 1218 1991 Glossary adult ATS ATS acceptability criteria ATS interpretive results baseline best effort BF bronchospasm evaluation BTPS CardioPerfect workstation composite norm value 59 Generally 18 or older Age limits vary with each norm American Thoracic Society An organization that provides standards for spirometry common practice and equipment Applicable to FVC testing only 1 Criteria ensuring that an individual effort started and ended satisfactorily no leaks or c
58. try function The CP150 spirometry option provides the ability to print test records on an internal printer The CP150 spirometry option allows storage of test records in device memory external storage media and external software applications Automatic interpretation and comparison of best pre bronchodilator effort to best post bronchodilator effort Real time flow volume and volume time graphs on full color LCD display Incentive graphics for patient coaching Multiple predictive norms including NHANES III Reduced risk of cross contamination with Welch Allyn single use disposable flow transducers Patient education help sheets Instant quality and variability checks for proper test performance Customizable report formats Directions for use Introduction Meets ATS ERS 2005 spirometry standards Single flow and multiple flow calibration protocols NIOSH protocols to create reports that meet agency requirements PCP primary care practitioner protocol that follows NLHEP guidelines Meets all industry standards including ATS and NIOSH Transfer results into the CardioPerfect workstation for easy analysis reviewing storing printing and exporting Compliant with the National Lung Health Education Program NLHEP guidelines for office spirometers For more information about NLHEP criteria visit http www nlhep org spirometer review process html 3 4 Introduction CP 150 spirometry option Controls indicators and connectors
59. u will eventually become short of breath while walking climbing stairs or doing other exercise It is very important that you seek help to stop smoking If you are able to successfully quit smoking sometime soon you will probably regain a little lung function within three months and the abnormally rapid decline in your lung function which you have experienced due to smoking will be stopped Call the number at the bottom of this page for information about local resources to help you quit smoking Your result FEV1 predicted For more information contact Date Directions for use About the patient help sheets 49 Asthma symptoms help sheet Name What Your Lung Function Results Mean For Those With Symptoms Suggesting Asthma You have just performed Spirometry the basic test of how well your lungs are working The results may indicate whether you have asthma and its severity ___ Your test was within the normal range If you recently had symptoms such as episodes of shortness of breath with wheezing chest tightness or cough you may have asthma but your lung function is normal today Consider visiting a physician when you again have asthma symptoms and then repeat this Spirometry test If you already know that you have asthma it is in good control ___ Your breathing test shows mild airways obstruction some narrowing of your breathing tubes You are currently unable to blow out air quickly This result may indicate asthma that
60. uracy Reproducibility Flow range Predictive norms Interpretation Specification 1 5X 1 2 x 3 3 in 37 mm x 30 mm x 85 mm 0 4 oz 12 g 2 2 yd 2 m 0 9 oz 25 g 1 2 x 4 3 x 0 6 in 31 mm x 108 mm x 14 mm 0 9 oz 25 g FVC pre and post bronchodilator Pneumotach Powered by CP150 electrocardiograph via USB port no battery 50 mA Max 30 mA typical Compliant with ATS ERS 2005 guidelines Compliant with ISO 26782 guidelines Compliant with ATS ERS 2005 guidelines Compliant with ISO 26782 guidelines 0 14 L s Berglund 1963 Crapo 1981 ECCS Quanjer 1993 Falaschetti 2004 Forche II Gore 1995 Gulsvik 2001 Hedenstr m 1986 Knudson 1976 Knudson 1983 Kory 1961 Morris 1971 NHANES III 1999 Paoletti 1986 Roca 1986 Schoenberg 1978 Viljanen 1981 1991 ATS interpretation standards Lung age calculation can be enabled or disabled Automatic interpretation can be enabled or disabled User definable interpretation statements are also available to be added manually 44 Specifications Item Reports FVC testing Parameters FVC testing Quality checks Connectivity Electrocardio protection against ingress of water per IEC 60529 Spirometer protection against ingress of water per IEC 60529 Protocols Environmental operating conditions Temperature Relative humidity Atmospheric air pressure limits Environmental storage conditions Temperature Relative humidity Atmosp
61. ydrocarbons rubbing alcohol or solvents on the spirometer CAUTION f you choose to clean the calibration syringe wipe the outer surface of the calibration syringe with a clean cloth slightly dampened with 70 percent isopropyl alcohol CAUTION Use only parts and accessories supplied with the device and available through Welch Allyn The use of accessories other than those specified may result in degraded performance of this device CAUTION When you put the spirometer away store its pressure tubing in a basket or drawer or other place that prevents compression or kinking CAUTION Avoid installing the spirometer in direct sunlight or in a location where it may be affected by significant changes in humidity ventilation or airborne particles containing dust salt or sulfur CAUTION Keep the spirometer away from splashing fluids 10 Introduction CP 150 spirometry option Setup Connecting the Spirometer A WARNING To prevent the spread of infection use a new flow transducer for each patient Use rubber gloves when replacing used flow transducers and wash hands after touching them Discard flow transducers after a single patient use Connecting the spirometer components 1 Attach the right side of the spirometer mounting bracket to the device using one of the thumb screws Tighten the thumbscrew 2 Insert the spirometer sensor into the mounting bracket Ensure that the spirometer sensor label is visible in the mounting

CP 150 spirometry option Directions for use

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