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Puritan-Bennett Renaissance II - User manual

1. 78 Device Options 2 es ds 2eme toes Gadel alana ep se date 80 Print Options B ias veran ht dad a RH bd du 80 SETTINGS 4 donee er eee e p M UEM anus MN ne Sealey ER DAG 83 Display Bir vrake RR Ra a ae RC ESA EGG 83 Storage B oo sisse Cnt b eaan ae seppur me qu ek SPUR dr GR es 83 Setup and System Configurations 84 Printing the System Configuration 86 ii P 495220 00 Rev D Table of Contents Barometric Pressure vs Altitude 87 Glossary of Medical Terminology 88 References iussi at oria cR ata aa CR RT Ra C TR CR ae aan ER ae 91 P 495220 00 Rev D iii Listing of Warnings Cautions and Notes Listing of Warnings Cautions and Notes Throughout this manual there are three indicators to convey information of a specific nature These indicators are warnings cautions and notes Carefully read and understand these notices as they relate to adjacent text Warnings alert the user to potential serious outcomes death injury or A adverse events to the patient or user CAUTION A Cautions alert the user to exercise care necessary for the safe and effective use of the Renaissance II Spirometry System NOTE Indicates points of particular emphasis that make operation of the spirometer more ef
2. 42 Grading Criteria otic vacca ceat cayenne tian 6G ea tao BLASS JJ Ge NE 44 Interpretation Criteria 44 Lung Age Interpretation 47 Risk of COPD res oreet Be E RR Im uper Eric Ere v 47 Graphic Displays 2c c ree the eR eee ae Ede due ads d 48 Service and Maintenance 49 Cleaning EMT 49 Battery Installation 49 Troubleshooting Guide 51 Electromagnetic Interference 54 Warranty Information 55 Technical References lis DD Product Specifications Renaissance Il Spirometer 57 Product Specifications Renaissance Il Base Station 58 The FSII Single Patient Use Flow Sensor 59 Predicted Normal Equations and References 60 RS 232 Interface Specifications 76 Pin Function Descriptions 76 Using the Renaissance II with a PC and Dataflow Software 77 System Configuration 78 Spirometry Options 1
3. 1 Renaissance II Spirometer PB 700 10 Base Station PB 710 2 FSII Flow Sensor 11 Nose Clip Plastic 3 AC Adapter PB 700 O ptional Accessories 4 Assy Pressure Tube FSII 12 3L Calibration Syringe 5 Syringe Adapter 13 Nose Clip Plastic 25 pk 6 User s Manual PB 700 PB 710 14 Cable Null Modem NPB 510 PB 710 7 Warranty Card PB 700 PB 710 15 DataFlow Data Management Software 8 Quick Guide PB 700 PB 710 16 Cable Printer 9 NiCad Battery Pack PB 700 17 Printer Spirometer Compatible Connecting the AC Adapter Connect the AC adapter to the 12 volt DC input jack on the side of the Renaissance II spirometer or on the rear of the base station as shown in 9 P 495220 00 Rev D Introduction to the Renaissance Il Spirometry System Figure 3 green LED indicator will light on the front panel of the Renaissance II spirometer and on the AC adapter when properly connected to an electrical outlet dry locations strangulation A To avoid risk of electrical shock this unit should only be used in As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or Battery Operation The Renaissance II spirometer includes a pre installed rechargeable custom NiCad battery pack As an option the user can install 4 AA alkaline batteries or 4 standard AA NiCad cells Refer to Battery Installation on page 49 for insta
4. F No acceptable maneuvers or reproducibility of gt 360 ml All other cases Table 7 Quality Grades for FEV6 FEV1 Tests At least 2 acceptable maneuvers with reproducibility of lt 100 ml At least 2 acceptable maneuvers with reproducibility of 150 ml At least 2 acceptable maneuvers with reproducibility of lt 200 ml goo gt At least 2 acceptable maneuvers with reproducibility of lt 200 ml OR at least 1 acceptable maneuver F No acceptable maneuvers P 495220 00 Rev D 44 Interpretation of the Results To ensure that the Quality Grades are displayed and printed in reports enable the QC Grades option in the Spirometry Options screen of the Setup menu see System Configuration and Spirometry Options 1 starting on page 78 for information on configuring the spirometer Interpretation Criteria Upon completion of an FVC or FEV6 test session the Renaissance II spirometer will generate an interpretation of the test data The interpretation criteria are those suggested by the American Thoracic Society statement Lung Function testing This computer suggested interpretation is an option that may be turned off in the configuration settings NOTE If Interpretation is turned OFF in the Print Options configuration the spirometer will not print the Comments heading Because data from poor patient efforts may result in false positive interpretations careful analysis mus
5. 0 08 0 079 0 084 0 092 0 102 0 090 0 093 0 096 0 062 0 048 0 038 0 132 0 152 0 128 0 097 0 061 0 067 0 040 0 026 0 093 0 120 0 154 FEF25 75 a b 0 247 1 668 0 254 1 710 0 195 1 933 0 161 2 091 0 185 2 120 0 294 1 976 0 450 1 711 0 581 1 486 0 654 1 366 0 688 1 290 NOTE The studies upon which these equations are based were not conducted by Puritan Bennett The appropriate regulatory agencies should be consulted for independent validation 75 P 495220 00 Rev D Technical References RS 232 Interface Specifications The Renaissance II Spirometry System supports asynchronous commun ications to a computer system via a RS 232C compatible serial port Data can be transmitted from the spirometer only when it is docked in the base station The interface connection on the base station is a standard 25 pin IBM PC AT style connector The pin locations for this connector are shown in Figure 33 Puritan Bennett recommends using a null modem cable to connect the spirometer base station Figure 33 Pin locations base station to a PC 3 12 11 10 9 8 7 6 5 4 3 2 1 25 24 23 22 21 20 19 18 17 16 15 14 Spirometer Base Station PB 710 Pin Function Descriptions The function of the pins is described in Pin Function Descriptions Table 11 Pins 12 13 14 16 and 18 are used for RS 232 communications for remote control of the spirometer All other pin
6. Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Cherniack et al 1 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 19 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Hsu et al 1979 Hsu et al 1979 Hsu et al 1979 Hsu et al 1979 972 76 Hsu et al 1979 Hsu et al 1979 Hsu et al 1979 Hsu et al 1979 Hsu et al 1979 P 495220 00 Rev D Technical References FEVO S 7778 FEVI Hsu et al 1979 FEV3 98 FVC Hsu et al 1979 MVV 99 507 1 267Hc Polgar et al 1971 Age 12 FEF50 2 5454 0 0378Hc Knudson et al 1983 FEF75 1 0149 0 0171Hc Knudson et al 1983 Age 2 12 FEF50 6 3851 0 1150A 0 0543Hc Knudson et al 1983 FEF75 4 2421 0 0057A 0 0397Hc Knudson et al 1983 Hsu FEMALE Limits age 7 17 years height 43 71 inches FVC 2 57 10 6 Hc 2 78 Hsu et al 1979 FVC LLN FVC 1 0 0 14 2 Hsu et al 1979 FEV1 3 79 10 6 Hc 2 68 Hsu et al 1979 FEV1 LN FEV1 1 0 0 14 2 Hsu et al 1979 FEF25 75 6 32 104 5 Hc 2 16 Hsu et al 1979 PEF 4 30 104 5 Hc 2 37 Hsu et al 1979 FEV1 PRED FEV1 PRED FVC 100 Hsu et al 1979 FEV1 LLN 0 90 FEV1 Hsu et al 1979
7. FIF50 FEFS0 FIF50 MVV MVV MVV Rate MVV MVV Rate MVV MVV Rate SVC SVC SVC SVC FEV6 FEV6 FEV6 FEV6 Any or all of these items may be specified in a User Defined report Accept M sgs Turning this option on will print the acceptability messages displayed during an FVC or FEV6 test provided that the last test is selected for printing Interpretation Enabling this option will print the computer generated interpretation in the report according to the configuration in Spirometry options see Spirometry Options 1 on page 78 Predicteds This setting determines how predicted graphical data will appear on the printed graphs The intent of the predicted graphical data is to produce a graphic reference of the patient s predicted values The options are curve points or none If you choose the curve option a simulated Flow Volume or Volume Time curve will be plotted using predicted data If you choose the points option the individual data points appear on the grid as small blocks 81 P 495220 00 Rev D System Configuration The following predicted points are plotted on each graph Flow Volume G raph Volume Time G raph PEF FEVO S FEF25 FEV1 FEF50 FEV3 FEF75 FVC or FEV6 FVC or FEV6 Graph The graph format setting allows you to choose which graphs will appear on the printed reports The options are both prints both volume time VT and flow volume FV graphs volume time VT flow volume FV or none Grid This settin
8. The Renaissance II Spirometry System consists of a spirometer docking base and optional accessories as shown in Figure 2 The Renaissance II system provides long term data storage capacity and when connected to a printer generates printouts of the data Patient data can also be downloaded to a computer The spirometer test results can be compared to any of several adult or pediatric predicted normal values The spirometer also performs pre post medication comparisons Features e Intuitive graphical user interface e Graphic display for real time viewing of Volume Time Flow Volume and incentive displays e Automatically compares results to predicted values e Allows pre post medication comparisons e Provides clinical interpretations with COPD Risk and Lung Age calculations e Optional software allows data to be downloaded to a computer e Memory stores demographic information graphical data and patient results for up to 1 000 patients e Operates with rechargeable NiCad batteries alkaline batteries or an AC adapter e Provides printed reports when connected to a parallel printer CAUTION AN e Place the Renaissance Il Spirometry System in a secure location where it is unlikely to drop or fall Do not attempt to lift or carry the Renaissance II spirometer by the pressure tube or power cord The Renaissance II system may be susceptible to radio frequency interference Refer to the Electromagnetic Interference section on
9. e Obstructing sensor opening with teeth lips or tongue while performing the test will cause low readings 5 P 495220 00 Rev D Listing of Warnings Cautions and Notes Notes Battery Notes The Renaissance II base station allows interfacing to parallel printers and computers and provides an alternate means for charging the custom NiCad battery pack The Renaissance II Spirometry System is designed to recharge only the custom battery pack supplied with the system and will not recharge batteries from other manufacturers When there is a low battery condition the Renaissance II spirometer beeps every 30 seconds and a low battery icon is displayed Do not mix brands or types of batteries e Puritan Bennett recommends replacing the NiCad battery pack at least once per year If the battery is removed the unit will operate solely on AC power if connected to an electrical outlet via the AC adapter Spirometer System Notes Theserial numbers are located on a label affixed to the underside of the spirometer and base station The first letter G represents the manufacturer The next two numbers represent the year of manufacture The two digits following the year represent either a base station 08 or a spirometer 07 The last five digits are sequential numbers assigned during manufacture Materials used to make this Renaissance Il Spirometry System and accessories contain no Latex Replace the pressure t
10. FIVC 2 57 10 6 Hc 2 78 Hsu et al 1979 FEVO S 7778 FEVI Hsu et al 1979 FEV3 98 FVC Hsu et al 1979 MVV 99 507 1 267Hc Polgar et al 1971 Age lt 11 FEF50 0 7362 0 1846A Knudson et al 1983 FEF75 0 1657 0 0109Hc Knudson et al 1983 Age 2 11 FEF50 2 3040 0 1111A 0 0288Hc Knudson et al 1983 FEF7S 4 4009 0 2923A 0 0243Hc Knudson et al 1983 0 0075 A 2 P 495220 00 Rev D 68 Technical References Polgar MALE Limits age 4 17 years height 43 67 inches FVC 4 4 10 6 Hc 2 67 FVC LLN FVC 1 1 645 0 13 FEV1 2 1 10 6 Hc 2 80 FEVI1 LLN FEV1 1 1 645 0 088 FEF25 75 3 4616 0 0437 Hc PEF 7 0929 4 08738 Hc FEV1 47 73 Hc 13 FEV1 LLN 0 90 FEV1 FIVC 4 4 10 6 Hc 2 67 FEVO S 7778 FEVI FEV3 98 FVC MVV 99 507 1 267Hc Age lt 12 FEF50 2 5454 0 0378Hc FEF75 1 0149 0 0171Hc Age 2 12 FEF50 6 3851 0 1150A 0 0543Hc FEF75 4 2421 0 00574 0 0397Hc Polgar FEMALE Limits age 4 17 years height 43 67 inches FVC FVC LLN FEV1 FEV1 LLN FEF25 75 PEF FEV1 FEV1 LLN FIVC FEVO S FEV3 MVV Age lt 11 FEF50 FEF75 Age gt 11 FEF50 FEF75 69 3 3 10 6 Hc 2 72 FVC 1 1 645 0 13 2 1 10 6 Hc 2 80 FEV1 1 1 645 0 088 3 4616 0 0437 Hc 7 0929 08738 Hc 63 63 Hc 08 0 90 FEV1 3 3 10 6 Hc 2 72 7778 FEVI 98 FVC 99 507 1 267Hc 0 7362 0 1846A 0 16
11. PRE MED TEST screen press 7 on the keypad or use the cur sor key to scroll to FEV6 and press ENTER 3 When prompted swipe the sensor or type the numeric code and press ENTER 4 Enter the room temperature and barometric pressure if necessary and press the DONE soft key The sensor will zero and the spirometer will dis play the FEV6 T EST screen and START TEST prompt Instruct the patient to e Place the sensor in his her mouth Close lips and teeth around the sensor in such a way that a tight seal is formed Coach the patient enthusiastically Take a good deep breath Pull pull it all in Now BLAST out Keep blowing harder That s good Squeeze it out squeeze it all out G ood job 5 The spirometer will display an incentive message and the elapsed time of the test while the real time curve is drawn To display an incentive bar graph instead of the real time curve press the IN CENT soft key when the Start Test prompt appears 6 The FEV6 test will automatically T i terminate after six seconds At this evem se time the spirometer displays the Ed tS flow volume curve measured val PEF 9 60 E FEF2575 3 31 ues acceptability messages quality Good Test grades number of maneuvers per FEV6 Grade formed and FEV6 and FEV1 vari FEv1 Grade A EP Attempts 4 ability Figure 25 To view the die SP volume time curve press the VT pu VES 72 SAVE DISCARD Figure 25
12. test AN 1 From the M AIN screen press 2 on the keypad or scroll to TEST using the cursor key and press ENTER 2 From the PRE MED TEST screen press 1 on the keypad or use the cur sor key to scroll to FVC and press ENTER 3 When prompted swipe the sensor or type the six digit numeric code and press ENTER 4 Enter the room temperature and barometric pressure if necessary and press the DONE soft key The sensor will zero and the spirometer will dis play the FVC TEST screen and START TEST prompt Figure 20 Instruct the patient to FVC TEST 01JAH2000 12 00PM fo et JANE DOE FEMALE 40YRS 65 e Place the sensor in his her mouth START TEST Flow US e Close lips and teeth around the 124 sensor in such a way that a tight 84 seal is formed a4 Coach the patient enthusiastically Figure 20 FVC Test Take a good 27 FVC TEST 01JAH2000 12 00PM deep breath JANE DOE FEMALE 40YRS 5 e FVC L 4774 Flow L S Pull pull it all FEV1 L 2 99 in Now BLAST Er 99831 R 9 03 out Keep FEF2575 3 31 8 Good Test blowing 4 FYC G de B harder EN ei dis Men That s good ke AREE er Squeeze it out FEv1 var MA ueeze it all vesens G e Good SAVE DISCARD job Figure 21 FVC Test Complete P 495220 00 Rev D Pre Med Testing Procedures 5 The spirometer will display an incentive message such as Keep Going or All the Way and the elapsed time of th
13. 15 000 feet Storage Temperature 20 to 60 C Storage Humidity 15 to 95 non condensing Storage Pressure 500hPa to 1060hPa Equipment Classification Enclosure Degree of Protection from liquid ingress IPX1 Applied Parts Type BF Mode of Operation Short time operation Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide Accuracy specifications are specified for 0 10 000 feet operation Table 10 Product Specifications Renaissance Il Base Station Dimensions 6 5 H x 4 75 W x 2 5 D Weight 80z Interface Centronics compatible IEEE 1284 parallel port for printer custom RS 232 compatible connection for computer interface Printout 8 1 2 X 11 or A4 Adapter charger Output 12VDC 400mA Adapter Input 120VAC 60Hz 52mA 9 55VA IEC 601 1 Medical Grade compliant P 495220 00 Rev D 58 Technical References Table 10 Product Specifications Renaissance Il Base Station cont Operating Temperature 17 to 40 C Operating Humidity 15 to 95 non condensing Operating Altitude Up to 15 000 feet Storage Temperature 20 to 60 C Storage Humidity 15 to 95 non condensing Storage Pressure 500hPa to 1060hPa Equipment Applied Parts Type BF Classification Mode of Operation Short time operation Equipment not suitable for use in the presence of a
14. 50 of FIVC FET Forced Expiratory Time measured in seconds The time from the beginning of the maneuver until the time at which highest volume was achieved during an FVC maneuver FEV0 5 Forced Expiratory Volume measured in one half second liters The volume of air exhaled in first half second of an FVC maneuver FEV1 Forced Expiratory Volume measured in one second liters The volume of air exhaled in the first second of an FVC maneuver FEV1 The ratio of FEV1 to FVC expressed as a percentage Also called FEV1 FVC FEV3 Forced Expiratory Volume measured in three seconds liters The volume of air exhaled in the first three seconds of an FVC maneuver FEV6 Forced Expiratory Volume measured in 6 seconds liters The volume of air exhaled in the first six seconds of an FVC maneuver Sometimes used as a surrogate for FVC P 495220 00 Rev D 88 Glossary of Medical Terminology FIVC Forced Inspiratory Vital Capacity measured in liters The maximum volume of air inspired with maximum effort after a complete exhalation Flow Volume Curve A graphic printout of an FVC FVL maneuver plotting flow vs vol ume FVC Forced Vital Capacity measured in liters The maximum volume of air exhaled as rapidly forcefully and completely as possible from the point of maximum inhalation FVL Flow Volume Loop an FVC maneuver that is immediately followed by a maximal inspiration HIPAA Health Insurance Portabilit
15. FEV6 Test Complete 33 P 495220 00 Rev D Pre Med Testing Procedures soft key To view the results as a percentage of the predicted values press the PRED soft key 7 Press the SAVE soft key if the maneuver is acceptable Press the DISCARD soft key if the maneuver is unacceptable The display returns to the PRE MED TEST screen 8 Select FEV6 again and repeat the above process up to eight times until at least three acceptable and two reproducible maneuvers have been obtained NOTE The value for FEV6 can only be obtained by administering an FEV6 test P 495220 00 Rev D 34 Post Med Testing Procedures Post Med Testing Procedures After completing the pre medication baseline testing administering the medication usually an inhaled bronchodilator and switching the spirometer to Post Med test mode the post medication testing may begin T AR FEMALE 40YRS JAHE DOE CHANGE TO POST MED TEST MODE The patient s session must be retrieved from memory if Post Med testing is Figure 26 Change to Post Med Test Mode performed on a patient whose Pre Med test was performed more than 30 minutes POST MED TEST 91348290 TZTEN JAHE DOE FEMALE 40YRS prior if spirometer has powered off or if Pre Med testing is performed on any patient other than the current one NOTES 4 e The LCD panel will turn off after 5 minutes and the unit will power off after 30 minutes with no user
16. II Spirometry System operates with selected Hewlett Packard Epson and Canon printers see Print Options 3 on page 80 for supported printers The spirometer s configuration settings may be changed to match the printer Refer to System Configuration on page 78 for information on changing the spirometer s configuration To print a report 1 Switch to the SELECT REPORT screen Figure 29 by pressing 6 SELECT REPORT 01JAN2000 m TPM from the M AIN screen or using MIT VEE an EEE the cursor key to scroll to PRINT EEES and pressing EN T ER Table 4 lists the available reports and their descriptions 1185 en 2 Connect a compatible printer to the REP ENE parallel port on the base station ESSEN ES using the printer cable see Table 1 LAST RO I item 16 The printer should be DONE OPTIONS turned off when connecting the Figure 29 Select m screen cable 3 Turn the printer on and verify that it is online and ready to print 4 Dock the Renaissance II spirometer onto the base station The spirometer must stay docked in the base station for the duration of printing If you wish to alter the format of the printed report press the OPTIONS soft key and change the information Press the DONE soft key to return to the SELECT REPORT screen 5 Press the appropriate number on the keypad or scroll to the desired report and press ENTER to send the report to the printer P 495220 00 Rev D 38 Post Test Procedures Table
17. JANE DOE FEMALE 40yrs 65 SSD Calibration Complete Syringe Volume 3 00 liters Expired Volume 3L S 2 98L Expired Error 0 796 Expired Volume 1L S 2 97 L Expired Error 1 0 Expired Volume 0 5L S 3 01 L Expired Error 0 4 Figure 13 SSD CAL Complete 20 Pre Test Procedures NOTE Verify that the temperature of the room is the same as the temperature noted for the calibration test For every degree discrepancy there will be a corresponding 0 1596 error in the test results NOTE Verify that the displayed barometric pressure is correct If not correct there will be an error in the inspired volume FIVC during an FVL maneuver of approximately 1 3 for every 1 000 feet above sea level Refer to the System Configuration section starting on page 78 for more information The barometric pressure displayed is based on the initial elevation setting of the spirometer However the barometric pressure may be changed and the spirometer will from that point on use the new value entered Cal Check CAUTION Prior to verifying calibration visually verify that there is no foreign material in the pressure tube and the tube is not damaged or kinked 1 Connect the pressure tube to the CAL CHECK OANA spirometer and to the FSII sensor Shown previously in Figures 3 and 4 E SWIPE SENSOR OR ENTER CODE 2 Following the power up and initial setup screens the CAL NOW DN LEUR A T Temperatu
18. Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Technical References 64 Technical References Age gt 25 and lt 35 FVC LLN 0 8150 FEVI LLN 0 8175 FEV1 LLN 0 8762 Age gt 35 FVC LLN 0 7446 FEV1 LLN 0 7292 FEV1 LLN 0 9188 FVC FEV1 FEV1 FVC FEV1 FEV1 Knudson 1976 FEMALE Limits age 18 88 years height 56 72 inches Age lt 20 FVC 3 469 0 092A 0 033Hc FEV1 2 703 0 085A 0 027Hc FEV3 3 417 0 086A 0 033Hc FEV1 107 38 0 109A 0 111Hc FEF25 75 1 893 0 121A 0 025Hc PEF 3 916 0 157A 0 049Hc FIVC 3 469 0 092A 0 033Hc FEVO S 1 738 0 061A 0 019Hc FEF50 2 3040 0 1111A 0 0288Hc FEF75 4 4009 0 2923A 0 0243Hc
19. Morris et al 1971 Morris et al 1971 Morris et al 1971 Cherniack et al 1972 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 P 495220 00 Rev D Age gt 20 PEF 0 735 0 025A 0 049Hc FEVO S 0 406 0 014A 0 019Hc FEF50 0 4371 0 0240A 0 0321Hc FEF75 0 1822 0 02544 0 0174Hc Age 2 70 PEF 0 735 0 025A 0 049Hc FEVO S 0 406 0 014A 0 019Hc FEF50 6 2402 0 07554 0 0118Hc FEF75 1 8894 0 0172A Knudson 1983 MALE Limits age 18 85 years height 58 80 inches Age 25 FVC 6 8865 0 0739A 0 0590Hc FVC LLN 0 798 FVC FEV1 6 1181 0 0636A 0 0519Hc FEV1 LLN 0 812 FEV1 FEV3 5 531 0 066A 0 052Hc FEV1 92 8965 1 4612FVC FEV1 LLN 0 848 FEV1 FEF25 75 6 1990 0 0749A 0 0539Hc PEF 8 060 0 166A 0 078Hc FIVC 6 8865 0 0739A 0 0590Hc FEVO S 3 054 0 043A 0 030Hc FEF50 6 3851 0 1150A 0 0543Hc FEF75 4 2421 0 00574 0 0397Hc MVV 37 94893 0 816214 3 02915Hi Age 2 25 FVC 8 7818 0 0298A 0 0844Hc FEV1 6 5147 0 0292A 0 0665Hc FEV1 96 3074 0 1677A 1 4232FVC FEV1 LLN 0 870 FEV1 FEV3 5 245 0 031A 0 063Hc FEF25 75 4 5175 0 0363A 0 0579Hc PEF 5 993 0 035A 0 094Hc FIVC 8 7818 0 0298A 0 0844Hc FEVO S 2 746 0 017A 0 037Hc FEF50 5 5409 0 0366A 0 0684Hc FEF75 2 4827 0 0230A 0 0310Hc MVV 37 94893 0 816214 3 02915Hi Age gt 25 and
20. Post Test Procedures Saving Results The Renaissance II spirometer saves all patient data and test data provided the SAVE soft key is pressed after each maneuver NOTES e Ifa maneuver is saved it is retained in memory until the entire patient session is deleted This includes abnormally large maneuvers that occur as a result of an occluded flow sensor and that subsequently may be labeled as the best maneuver e The spirometer will store multiple tests for each maneuver but will only display and print up to the best three Pre Med and Post Med FVC FVL and FEV6 maneuvers the single best Pre Med and Post Med SVC and MVV maneuvers and the last maneuver performed e If the user does not press the POST soft key prior to performing Post Med tests the maneuvers will be stored as Pre Med tests and cannot be transferred to Post Med status Viewing Results The patient whose test results are currently in memory may be viewed in several formats 1 From the M AIN screen press 3 SELECT VTEW V1JAN2000 m DOM JANE DOE FEMALE 40YRS on the keypad or scroll to the VIEW option and press ENTER eh 7 2 The SELECT VIEW screen 2 appears indicating the view options as shown in Figure 28 See Table 3 m 5 pay tus BEST 3 CAL CHECK for the definitions of each option DONE Figure 28 Select View screen P 495220 00 Rev D 36 Post Test Procedures Table 3 View Options 5 7 Displays results for the si
21. Refer to the warranty card s that came with your Renaissance II Spirometry System and accessories for specific warranty periods If Puritan Bennett establishes a need of repair another unit of comparable value will be dispatched as soon as possible The foregoing warranty shall not apply and Puritan Bennett shall be relieved of any obligation or liability if the component has been Repaired or altered including the use of parts other than those manufactured or approved by Puritan Bennett Serviced by anyone other than Puritan Bennett Subjected to abuse negligence or accident Reused when sold for single patient use only Connected to the wrong AC adapter CAUTION Do not remove the cover of the Renaissance II spirometer or base station Removal of the cover is permitted only by qualified service personnel There are no user serviceable parts inside Puritan Bennett does not warrant accessories for the Renaissance II Spirometry System such as the printer that are not manufactured by or for Puritan Bennett The end user is required to seek warranty assistance directly from the manufacturer of these accessories 55 P 495220 00 Rev D Troubleshooting Guide Also the warranty may be voided if the system is used with any sensor other than those manufactured or licensed by Puritan Bennett for use with the Renaissance II Spirometry System Please reference the warranty enclosed with your system for full clarification of the w
22. Reference Spirometric Values Using Techniques and Equip ment that Meets ATS Recommendations American Review of Respiratory Disease 1981 123 659 674 Hsu Katharine et al Ventilatory Functions of Normal Children and Young Adults Mexican American White and Black Journal of Pediatrics 1979 95 14 23 Knudson Ronald J et al Changes in the Normal Maximal Expiratory Flow Vol ume Curve with Aging American Review of Respiratory Disease 1983 127 725 734 Knudson Ronald J et al Tbe Maximal Expiratory Flow Volume Curve American Review of Respiratory Disease 1976 113 587 600 Morris James E et al Normal Values and Evaluation of Forced Expiratory Flow American Review of Respiratory Disease 1975 111 755 761 Morris James E et al Spirometric Standards for Healthy Non Smoking Adults American Review of Respiratory Disease 1971 103 57 67 Polgar P Promadhat V Pulmonary Testing in Children W B Saunders Philadel phia 1971 100 153 Wang Xiaobin D W Dockery ScD David Wypij PhD Martha E Fay MPH and Benjamin G Ferris Jr MD Pulmonary Function Between 6 and 18 Years of Age Pediatric Pulmonology 1993 15 75 88 AM Rev Respir Dis 1987 Standardization of Spirometry 136 1285 98 1987 Update ATS AM J Respir Crit Care Med 1995 Standardization of Spirometry 152 1107 1136 1994 Update ATS American Thoracic Society AM Rev Respir Dis Spirometry in the Lung Health Study 1991 143 1215 12
23. a b 6 0 024 2 470 7 0 018 2 489 8 0 005 2 443 9 0 017 2 426 10 0 030 2 407 11 0 009 2 468 12 0 061 2 649 13 0 175 2 924 14 0 219 3 060 15 0 079 2 859 16 0 104 2 591 17 0 253 2 374 P 495220 00 Rev D FEV1 0 109 0 104 0 089 0 063 0 057 0 093 0 161 0 292 0 329 0 141 0 062 0 262 2 252 2 270 2 257 2 197 2 212 2 324 2 512 2 843 2 983 2 709 2 409 2 099 FEV1 FEF25 75 a b a b 0 078 0 248 _ _ 0 086 0 220 0 091 0 199 0 264 1 505 0 086 0 206 0 308 1 443 0 081 0 209 0 290 1 557 0 101 0 147 0 242 1 738 0 101 0 133 0 165 1 982 0 116 0 085 0 007 2 396 0 106 0 087 0 014 2 483 0 060 0 155 0 241 2 163 0 045 0 178 0 503 1 764 0 008 0 272 0 762 1 368 74 Technical References Dockery Wang Dockery et al 1993 FEMALE Caucasian Age 6 17 AGE FVC FEV1 a b a b 6 0 013 2 007 0 109 1 949 7 0 062 2 385 0 144 2 243 8 0 055 2 381 0 137 2 239 9 0 039 2 351 0 123 2 222 10 0 068 2 458 0 161 2 364 11 0 120 2 617 0 223 2 558 12 0 174 2 776 0 264 2 709 13 0 061 2 576 0 153 2 535 14 0 139 2 208 0 046 2 178 15 0 210 2 099 0 148 2 008 16 0 226 2 097 0 181 1 972 17 0 214 2 146 0 176 1 992 Dockery MALE Wang Dockery et al 1993 FVC LLN 0 830 FVC FEV1 LLN 0 825 FEV1 FEV1 LLN 0 890 FEV1 Dockery FEMALE Wang Dockery et al 1993 FVC LLN 0 822 FVC FEV1 LLN 0 823 FEV1 FEV1 LLN 0 895 FEV1 FEV1 a b 0 097 0 055
24. be an error in the inspired volume FIVC during an FVL maneuver of approximately 1 3 for every 1 000 feet above sea level Refer to the System Configuration section starting on page 78 for more information The barometric pressure displayed is based on the initial elevation setting of the spirometer However the barometric pressure may be changed and the spirometer will from that point on use the new value entered P 495220 00 Rev D 24 Entering New Patient Data Entering New Patient Data 1 2 From the M AIN screen press 1 on the keypad or use the cursor key to scroll to the NEW option and press ENTER When prompted to start a new patient press the Y ES soft key Pressing NO will return you to the M AIN screen Enter data on the NEW PATIENT screen by using alpha or numeric characters when appropriate Press ENT ER after each field is completed Numbers may be entered directly using the numeric keys with the spirome ter in numeric mode Alpha characters can only be entered with the spirom eter in alpha mode NOTE When in numeric mode Figure 18 only numbers may be typed on the key pad Pressing the ABC soft key puts the key pad into alpha character mode Figure 19 allowing both letters and numbers to be entered from the key pad Alpha character entry is modeled after cell phones For example the first key press displays the first letter the second press displays the second letter and so on u
25. e Demonstrating the test using your own FSII sensor is strongly recommended for patients who have never performed a spirometry test before e The American Thoracic Society ATS recommends performing a three speed calibration check on a daily basis Materials used to make this Renaissance Il Spirometry System and accessories contain no Latex Verify that the opening of the sensor is not blocked Instruct the patient to e Relax e Loosen tight clothing such as neckties or tight collars e Remove dentures candy gum etc e Elevate chin and extend the neck slightly e Avoid leaning forward e Use a nose clip if available strongly recommended e Blast out air forcefully completely and as long as possible 23 P 495220 00 Rev D Pre Test Procedures Results from spirometry testing should not be the sole source A for determining a patient s diagnosis and treatment Other clinical data such as patient symptoms and respiratory history should always be considered Predicted values will be extrapolated for patients with age or height outside the age and or height limits supported by the selected author s normal equations NOTES e Verify that the temperature of the room is the same as the temperature noted for the calibration test For every degree discrepancy there will be a corresponding 0 1596 error in the test results e Verify that the displayed barometric pressure is correct If not correct there will
26. flammable anesthetic mixture with air or oxygen or nitrous oxide The FSII Single Patient Use Flow Sensor The Renaissance II Spirometry System uses Puritan Bennett s unique individually calibrated disposable FSII sensor The single patient use sensor eliminates the need to clean or sterilize any part of the spirometry system The FSII sensor is designed for single patient use only This minimizes the effects of cross contamination The FSII disposable sensor is used for all testing procedures A 6 digit code is printed on the sensor in two forms e Numeric code e Bar code The code can be entered manually or by swiping the sensor through the bar code reader located on the spirometer The sensor code contains information about the linearity characteristics of the sensor The spirometer needs this information to accurately calculate the spirometric parameters The numeric code is entered with each new patient each time a calibration check is performed or anytime a new sensor is used Your supply of sensors should be stored in a cool location Each sensor should remain sealed in a plastic bag until ready for use CAUTION e Use only the FSII flow sensor specifically designed for the Renaissance II Spirometry System The FSII sensor is for single patient use only In the interest of environmental protection dispose of all sensors and nose clips properly 59 P 495220 00 Rev D Technical References Predicted No
27. guarantee coverage or payment for any procedure by any payer In any case reimbursement is only available for medically necessary procedures in accordance with specific payer guidelines To print an ROI report 1 From the SELECT REPORT screen press 9 or scroll to ROI and press ENTER Type the purchase price and press ENTER Type the number of tests performed per week and press ENTER Type the cost per test and press ENTER Type the amount reimbursed per test The ROI is displayed on the screen Press the PRINT soft key to print the ROI report or the DONE soft key to return to the SELECT REPORT screen without printing gu sop Printing Reports for Multiple Patients The Renaissance II spirometer allows printing reports for multiple patients at the same time To print multiple reports 1 Prepare the printer and spirometer system as described above The spirom eter must stay docked in the base station for the duration of printing 2 From the M AIN screen press 7 on the keypad or scroll to FIND with the cursor arrow key and press ENTER 3 Press the SCROLL soft key 4 Use the cursor arrow key to highlight the patient whose record you want to print To print all patient records highlight any patient 5 Press the MARK soft key 6 Press the CURRENT soft key to select the record Continue with the cur sor arrow key and CURRENT soft key to highlight and select the patient records you want to print To select al
28. if the QC Grades option is enabled The Quality Grades are an indication of the reliability of each of these measurements and physicians may use them to judge their degree of confidence in the results The grades are also an indicator of the short term reproducibility of the FVC FEV1 and FEV6 FEV1 measurements for that patient The Renaissance II assigns a Quality Grade according to the criteria shown in Tables 6 and 7 Use the grade in conjunction with the Acceptability Messages and coaching instructions in Table 5 to improve patient test performance NOTE It is possible to have a Good Test Acceptability Message accompanied by a low QC grade If the first FVC or FEV6 maneuver is acceptable the Quality Grade will be D by definition see Tables 6 and 7 It is not until there are at least 2 acceptable maneuvers that there is the possibility for a higher QC grade Table 6 Quality Grades for FVC FEV1 Tests A At least 3 acceptable maneuvers with reproducibility of 120 ml Exceeds ATS acceptability and reproducibility criteria B At least 3 acceptable maneuvers with reproducibility of lt 200 ml Meets ATS acceptability and reproducibility criteria C At least 2 acceptable maneuvers with reproducibility of lt 280 ml Slightly below ATS acceptability and reproducibility criteria D At least 1 acceptable maneuver with reproducibility of lt 360 ml Substantially below ATS acceptability and reproducibility criteria
29. lt 39 FVC LLN 0 811 FVC FEV1 LLN 0 791 FEV1 P 495220 00 Rev D Technical References Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1983 Knudson et al 1983 62 Technical References Age gt 40 FVC LLN 0 734 FVC FEV1 LLN 0 772 FEV1 Knudson 1983 FEMALE Limits age 18 88 years height 56 72 inches Age 20 FVC 4 4470 0 0699A 0 0416Hc FVC LLN 0 749 FVC FEV1 3 7622 0 0694A 0 0351Hc FEV1 LLN 0 818 FEV1 FEV3 3 417 0 086A 0 033Hc FEV1 91 9381 1 5226A 7 7593FVC FEV1 LLN 0 833 FEV1 FEF25 75 2 8007 0 1275A 0 0279Hc PEF 3 916 0 157A 0 049Hc FIVC 4 4470 0 0699A 0 0416Hc FEVO S 1 738 0 061A 0 019Hc FEF
30. mac ecce sca DR Calibration Verification 22252 ce Re eR ERR Me as dan ad pb on ks 17 SSD Calibration Verification 17 Cal Check ots tae vas e ne Rap e EUR a A IT TEN RE 21 Patient Preparation saien2nenc eot ente annales DR decir A ERU Did E 23 Entering New Patient Data 25 Pre Med Testing Procedures 27 FVC Forced Vital Capacity Test Procedure 27 SVC Slow Vital Capacity Test Procedure 29 FVL Flow Volume Loop Test Procedure 30 MVV Maximal Voluntary Ventilation Test Procedure 32 FEV6 Forced Expiratory Volume in 6 sec Test Procedure 33 Post Med Testing Procedures 35 Post Test Procedures isse nnn 30 Saving Results as a d teneo qe eec oae d o e UR UC ete RA TR Rd 36 Viewing Results rer zr ev RR A a ch mda ee Rn eR d 36 P 495220 00 Rev D i Table of Contents Printing Results 2c ar avo an sonate ere PR ROC VR SO ER RR AO Bre aus 38 Printing Reports for Multiple Patients 40 Deleting Patient Data ss oues ve ect eder PARA REGERE oe 41 Interpretation of the Results 42 Acceptability and Reproducibility
31. patients NOTE Replace the pressure tube every year The Renaissance II Spirometry System is not intended for use in A an oxygen enriched atmosphere or in the presence of flammable anesthetics e Carefully read the flow sensor directions before use including all warnings cautions and instructions CAUTION AN Do not spray liquids on the Renaissance Il System Follow the cleaning instructions outlined in the Service and Maintenance section starting on page 49 of this manual P 495220 00 Rev D 12 Introduction to the Renaissance Il Spirometry System Keypad Functions and Controls The keypad functions and controls are user friendly and intuitive The keypad and Main screen icons shown in Figure 5 represent some of the most frequently seen icons that will be displayed The keypad and controls are used to access the various functions of the Renaissance II spirometer Main Screen Icon Features M32 TEST Allows the user to enter new patient data Begins or continues a spirometry test or allows SSD calibration Allows the user to view the test results Allows the user to edit previously entered patient data Initiates one speed spirometer calibration Provides a variety of S 6 printed test reports PRINT Locates a patient s 427 previously saved test data Allows the user to configure the spirometer On Off is controlled by the key marked I O On Off The en
32. syringe and follow the instructions starting on page 19 There is no need to enter any patient information prior to performing this verification The date and time of the calibration verification will be retained in memory until the next time a calibration verification is performed Social Security Disability Testing requires that the calibration error at the tested flow rates is within 1 of the calibrating volume In order for the spirometer to meet the 1 requirement a correction factor must be obtained to correct the measured volume This correction factor is then applied to the measurements obtained during the patient tests For this reason the sensor used to verify the spirometer s calibration for an SSD claims submission must also be used for the actual patient test 17 P 495220 00 Rev D Pre Test Procedures NOTE If the patient test will be submitted for Social Security Disability SSD determinations enter patient information prior to performing the SSD calibration verification CAUTION A Prior to verifying calibration visually verify that there is no foreign material in the pressure tube and the tube is not damaged or kinked P 495220 00 Rev D 18 Pre Test Procedures 9 From the M AIN screen press 2 on the keypad or scroll to TEST using the cursor key and press ENTER Figure 8 From the PRE M ED TEST screen press 3 on the keypad or use the cur sor key to scroll to SSD CAL and press ENTE
33. the choices for each option Spirometry Options 1 Interpretation The interpretation option determines whether the displayed and printed reports will include a computer generated interpretation If you choose to include interpretations you can select either the ATS or Enright algorithms for spirometry tests NOTE The patient s height birth date and gender must be entered or no interpretation will be displayed Adult Normals This configuration determines which set of equations will be used to generate the predicted values for patients 18 to 99 years of age These predicted values appear on the display and printed reports and are used to derive the percent of predicted and the interpretation The options are Knudson 1983 Morris Knudson 1976 Crapo Morris and NHANES III The option chosen will appear on each printed report For the specified equations and references see the Predicted Normal Equations and References section starting on page 60 Pediatric N ormals This configuration determines which set of equations will be used to generate the predicted values for patients 4 to 17 years of age These predicted values appear on the display and printed reports and are used to derive the percent of predicted and the interpretation The options are Hsu Polgar Dockery and NHANES III The option chosen will appear on each printed report For the specific equations and references see the Predicted Normal Equations and Referen
34. 0 0075 A 2 MVV 4 86957 0 685A 2 1384Hi Age 25 FVC LLN 0 7575 FVC FEVI LLN 0 7138 FEV1 FEV1 LLN 0 8313 FEV1 Age gt 25 and lt 35 FVC LLN 0 7575 FVC FEVI LLN 0 7138 FEV1 FEV1 LLN 0 8313 FEV1 Age gt 35 FVC LLN 0 6646 FVC FEV1 LLN 0 6940 FEV1 FEV1 LLN 65 0 8806 FEV1 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1976 P 495220 00 Rev D Age gt 20 and lt 70 FVC 1 774 0 0224 0 037Hc FEV1 0 794 0 021A 0 027Hc FEV3 1 633 0 023A 4 0 035Hc FEV1 107 38 0 109A 0 111Hc FEF25 75 1 171 0 024A 0 021Hc PEF 0 735 0 025A 0 049Hc FIVC 1 774 0 022A 0 037Hc FEVO S 0 406 0 014A 0 019Hc FEF50 0 4371 0 0240A 4 0 0321Hc FEF75 0 1822 0 0254A 0 0174Hc MVV 4 86957 0 685A 2 1384Hi Age 270 FVC 1 774 0 0224 0 037Hc FEV1 0 794 0 021A 0 027Hc FEV3 1 633 0 023A 0 035Hc FEV1
35. 0 2376 0 008914 0 000182 A 2 0 00014947 Hc 2 7 P 495220 00 Rev D Technical References PEF 0 0870 0 065802 0 001195 A2 0 00030243 Hc 2 PEF LLN 0 0870 0 06580A 0 001195 A2 0 00021833 Hc 2 FEF25 75 1 7503 0 05018A 0 00014473 Hc 2 FEF25 75 LLN 1 7503 0 05018A 0 00009020 Hc 2 NHANES III FEMALE Hankinson et al 1999 Caucasian Age 18 FEV1 0 8710 0 06537A 0 00011496 Hc 2 FEV1 LLN 0 8710 0 06537A 0 00009283 Hc 2 FEV6 1 1925 0 06544A 0 00014395 Hc 2 FEV6 LLN 1 1925 0 06544A 0 00011827 Hc 2 FVC 1 2082 0 0591A 0 00014815 Hc 2 FVC LLN 1 2082 0 0591A 0 00012198 Hc 2 PEF 3 6181 0 606441 0 016846 A 2 0 00018623 Hc 2 PEF LLN 3 6181 0 60644A 0 016846 A 2 0 00012148 Hc 2 FEF25 75 2 5284 0 52490A 0 015309 A 2 0 00006982 Hc 2 FEF25 75 LLN 2 5284 0 52490A 0 015309 A 2 0 00002302 Hc 2 Caucasian Age gt 18 FEV1 0 4333 0 00361A 0 000194 A 2 0 00011496 Hc 2 FEV1 LLN 0 4333 0 00361A 0 000194 A 2 0 00009283 Hc 2 FEV6 0 1373 0 01317A 0 000352 A 2 0 00014395 Hc 2 FEV6 LLN 0 1373 0 01317A 0 000352 A 2 0 00011827 Hc 2 FVC 0 3560 0 01870A 0 000382 A 2 0 00014815 Hc 2 FVC LLN 0 3560 0 01870A 0 000382 A 2 0 00012198 Hc 2 PEF 0 9267 0 06929A 0 001031 A 2 0 00018623 Hc 2 PEF LLN 0 9267 0 069294 0 001031 A 2 0 00012148 Hc 2 FEF25 75 2 3670 0 01
36. 107 38 0 109A 0 111Hc FEF25 75 1 171 0 024A 0 021Hc PEF 0 735 0 025A 0 049Hc FIVC 1 774 0 0224 0 037Hc FEVO S 0 406 0 014A 0 019Hc FEF50 6 2402 0 0755A 0 0118Hc FEF75 1 8894 0 0172A MVV 4 86957 0 685A 2 1384Hi Crapo MALE Limits age 18 89 years height 61 77 inches FVC 4 650 0 0214A 0 0600Hc FVC LLN FVC 1 115 FEV1 2 190 0 02444 0 0414Hc FEV1 LLN FEV1 0 842 FEV3 3 512 0 02714 0 0535Hc FEF25 75 2 133 0 0380A 0 0204 Hc FEV1 110 49 0 1520A 0 1300Hc FEV1 LLN FEV1 8 28 FEVO S 1 914 0 0152A 0 0327Hc FIVC 4 650 0 0214A 0 0600Hc MVV 37 94893 0 81621A 3 02915Hi Age 25 PEF 8 060 0 166A 0 078Hc FEF50 6 3851 0 1150A 0 0543Hc FEF75 4 2421 0 00574 0 0397Hc P 495220 00 Rev D Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et al 1981 Crapo et a
37. 12154 Hc 2 FEV1 LLN 0 9641 0 06490 A 0 00009890 Hc 2 FEV6 1 2410 0 07625A 0 00014106 Hc 2 FEV6 LLN 1 2410 0 07625A 0 00011480 Hc 2 FVC 1 2507 0 07501A 0 00014246 Hc 2 FVC LLN 1 2507 0 07501A 0 00011570 Hc 2 PEF 3 2549 0 47495A 0 013193 A 2 0 00022203 Hc 2 PEF LLN 3 2549 0 47495A 0 013193 A 2 0 00014611 Hc 2 73 P 495220 00 Rev D Technical References FEF25 75 2 1825 0 42451A 0 012415 A 2 0 00009610 Hc 2 FEF25 75 LLN 2 1825 0 42451A 0 012415 A 2 0 00004594 Hc 2 Mexican American Age gt 18 FEV1 0 4529 0 01178A 0 000113 A 2 0 00012154 Hc 2 FEV1 LLN 0 4529 0 01178A 0 000113 A 2 0 00009890 Hc 2 FEV6 0 2033 0 00020A 0 000232 A 2 0 00014106 Hc 2 FEV6 LLN 0 2033 0 00020A 0 000232 A 2 0 00011480 Hc 2 FVC 0 1210 0 00307A 0 000237 A 2 0 00014246 Hc 2 FVC LLN 0 1210 0 00307A 0 000237 A 2 0 00011570 Hc 2 PEF 0 2401 0 06174A 0 001023 A2 0 00022203 Hc 2 PEF LLN 0 2401 0 06174A 0 001023 A 2 0 00014611 Hc 2 FEF25 75 1 7456 0 0119A 0 000291 A 2 0 00009610 Hc 2 FEF25 75 LLN 1 7456 0 0119A 0 000291 A 2 0 00004594 Hc 2 Dockery Wang Dockery et al 1993 The regression model is x exp a b In H where x is FVC L FEV1 L FEV1 or FEF25 75 L s H is height in meters and a and b are constants listed in the tables MALE Caucasian Age 6 17 AGE FVC
38. 23 American Thoracic Society Lung Function testing AM Rev Respir Dis Selection of Reference Values and Interpretative Strategies 144 1202 1218 1991 Morris J F and Temple W Spirometric Lung Age Estimation for Motivating Smoking Cessation Preventative Medicine Volume 14 1985 p 655 662 Higgins MN Keller J B AM Rev Respir Dis Risk of Chronic Obstructive Pulmonary Disease 1984 130 380 385 Hankinson John Odencrantz John and Fedan Kathleen Spirometric Reference Values from a Sample of the General U S Population NHANES III American Journal of Respiratory and Critical Care Medicine 1999 159 183 184 Ferguson G T et al NLHEP Office Spirometry for Lung Health Assessment in Adults Chest Volume 117 2000 p 1146 1161 P 495220 00 Rev D Notes Notes P 495220 00 Rev D 92 Notes 93 P 495220 00 Rev D PURITAN BENNETT Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton CA 94588 USA Toll Free 1 800 635 5267 Rx ONLY 2003 Nellcor Puritan Bennett Inc All rights reserved P 495220 00 Rev D 10 03
39. 241 0 025A 0 148Hi MVV 37 94893 0 81621A 3 02915Hi Age lt 25 PEF 8 060 0 166A 0 078Hc FEVO S 3 054 0 043A 0 030Hc FEF50 6 3851 0 1150A 0 0543Hc FEF75 4 2421 0 00574 0 0397Hc Age 2 25 PEF 5 993 0 035A 0 094Hc FEVO S 2 746 0 017A 0 037Hc FEF50 5 5409 0 0366A 0 0684Hc FEF75 2 4827 0 0230A 0 0310Hc Morris FEMALE Limits age 18 90 years height 56 72 inches FVC FVC LLN FEV1 FEV1 LLN FEV1 FEV1 LLN FEV3 FEF25 75 FIVC MVV Age lt 20 PEF FEVO S FEF50 FEF75 61 2 852 0 024A 0 115Hi FVC 1 645 0 52 1 932 0 025A 0 089Hi FEVI1 1 645 0 47 88 70 0 1815A 0 0679Hi FEV1 1 645 6 84 FVC 0 95 0 551 0 030A 0 060Hi 2 852 0 024A 0 115Hi 4 86957 0 685A 2 1384Hi 3 916 0 157A 0 049Hc 1 738 0 061A 0 019Hc 2 3040 0 1111A 0 0288Hc 4 4009 0 2923A 0 0243Hc 0 0075 A 2 Morris et al 1971 Morris et al 1971 Morris et al 1971 Morris et al 1971 Morris et al 1975 Morris et al 1971 Morris et al 1971 Morris et al 1971 Morris et al 1971 Cherniack et al 1972 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Morris et al 1971 Morris et al 1971 Morris et al 1971 Morris et al 1971 Morris et al 1975 Morris et al 1971
40. 3 To view the volume a NI oi time curve press the VT soft key To At tempts 1 4 view the results as a percentage of FEv1 var e eor eed olume the predicted values press the SAVE DISCARD VT PRED PRED soft key Press the SAVE soft key if the maneuver is acceptable Press the DISCARD soft key if the maneuver is unacceptable The display returns to the PRE M ED TEST Screen Select FVL again and repeat the above process up to eight times until at least three acceptable and two reproducible maneuvers have been obtained Figure 23 FVL Test Complete P 495220 00 Rev D Pre Med Testing Procedures MVV Maximal Voluntary Ventilation Test Procedure Patient fainting or falling due to dizziness may occur as a result of this A test Advise the patient to sit or stand comfortably near a chair during test 1 From the MAIN screen press 2 on the keypad or scroll to TEST using the cursor key and press ENTER 2 From the PRE MED TEST screen press 5 on the keypad or use the cur sor key to scroll to M VV and press ENTER 3 When prompted swipe the sensor or type the numeric code and press ENTER 4 Enter the room temperature and barometric pressure if necessary and press the DONE soft key The sensor will zero and the spirometer will display the M VV TEST screen and START TEST prompt Instruct the patient to Place the sensor in his her mouth Close lips and teeth around the sensor in
41. 4 Report Selections Prints the results for the single best Pre Med and Post as Med effort for each type of maneuver as defined by the A 7 Best Criteria configured in Spirometry Options BEST Prints a report suitable for Social Security Disability claims submissions Prints the spirometer configuration settings Prints test results for the best three Pre Med and Post Med FVC FVL and FEV6 maneuvers and the single best Pre Med and Post Med SVC and MVV maneuvers as defined by the Best Criteria configured in Spirometry Options Prints the results of the last calibration check Prints the test results for the most recent maneuver 9 Displays or prints a Return On Investment report RO I See System Configuration and Spirometry Options 1 on page 78 for information on configuring the spirometer 39 P 495220 00 Rev D Post Test Procedures The Return on Investment ROI Report can be used as a cost management tool for calculating and displaying Total Income Total Cost Net Income ROI and Payback in months based upon the following values supplied by the user e Purchase price e Covered tests per week e Cost per covered test e Reimbursement per test The Renaissance II calculates ROI and Payback in the following manner ROI Reimbursement Cost per covered test x 100 Payback months Purchase price Net income monthly NOTE The existence of coding does not
42. 50 2 3040 0 1111A 0 0288Hc FEF7S 4 4009 0 2923A 0 0243Hc 0 0075 A 2 MVV 4 86957 0 685A 2 1384Hi Age gt 20 and lt 70 FVC 3 1947 0 0169A 0 0444Hc FEV1 1 8210 0 0190A 0 0332Hc FEV3 1 633 0 023A 0 035Hc FEV1 113 694 0 2904A 5 4024FVC FEV1 LLN 0 854 FEV1 FEF25 75 0 4057 0 03094 0 0300Hc PEF 0 735 0 025A 0 049Hc FIVC 3 1947 0 01694 0 0444Hc FEVO S 0 406 0 014A 0 019Hc FEF50 0 4371 0 0240A 0 0321Hc FEF75 0 1822 0 0254A 0 0174Hc MVV 4 86957 0 685A 2 1384Hi Age gt 20 and 39 FVC LLN 0 769 FVC FEVI LLN 0 703 FEVI Age gt 40 and lt 70 FVC LLN 0 752 FEV1 LLN 0 779 FEV1 63 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Cherniack et al 1972 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 P 495220 00 Rev D Age 2 70
43. 57 0 0109Hc 2 3040 0 1111A 0 0288Hc 4 4009 0 29234 0 0243Hc 0 0075 A 2 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Polgar et al 1971 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 Knudson et al 1983 P 495220 00 Rev D NHANES III MALE Hankinson et al 1999 Caucasian Age lt 20 FEV1 FEV1 LLN FEV6 FEV6 LLN FVC FVC LLN PEF PEF LLN FEF25 75 FEF25 75 LLN Caucasian Age gt 20 FEV1 FEV1 LLN FEV6 FEV6 LLN FVC FVC LLN PEF PEF LLN FEF25 75 FEF25 75 LLN African American Age lt 20 FEV1 FEV1 LLN FEV6 FEV6 LLN FVC FVC LLN PEF PEF LLN P 495220 00 Rev D 0 7453 0 04106A 0 004477 0 7453 0 04106A 0 004477 0 3119 0 18612A 0 009717 0 3119 0 18612A 0 009717 0 2584 0 20415A 0 010133 0 2584 0 20415A 0 010133 0 5962 0 12357
44. 904A 0 000200 A 2 0 00006982 Hc 2 FEF25 75 LLN 2 3670 0 01904A 0 000200 A 2 0 00002302 Hc 2 P 495220 00 Rev D 72 Technical References African American Age lt 18 FEV1 0 9630 0 057994 0 00010846 Hc 2 FEV1 LLN 0 9630 0 057994 0 00008546 Hc 2 FEV6 0 6370 0 042434 0 003508 A2 0 00013497 Hc 2 FEV6 LLN 0 6370 0 04243A 0 003508 A2 0 00010848 Hc 2 FVC 0 6166 0 04687 A 0 003602 A 2 0 00013606 Hc 2 FVC LLN 0 6166 0 04687 A 0 003602 A 2 0 00010916 Hc 2 PEF 1 2398 0 163750A 000109746 Hc 2 PEF LLN 1 2398 0 163750A 0 00012160 Hc 2 FEF25 75 2 5379 0 437554 0 012154 A 2 0 00008572 Hc 2 FEF25 75 LLN 2 5379 0 43755A 0 012154 A 2 0 00003380 Hc 2 African America Age gt 18 FEV1 0 3433 0 01283A 0 000097 A 2 0 00010846 Hc 2 FEV1 LLN 0 3433 0 01283A 0 000097 A2 0 00008546 Hc 2 FEV6 0 1981 0 000474 0 000230 A 2 0 00013497 Hc 2 FEV6 LLN 0 1981 0 00047A 0 000230 A2 0 00010848 Hc 2 FVC 0 3039 0 00536A 0 000265 A 2 0 00013606 Hc 2 FVC LLN 0 3039 0 00536A 0 000265 A 2 0 00010916 Hc 2 PEF 1 3597 0 03458A 0 000847 A 2 0 00019746 Hc 2 PEF LLN 1 3597 0 03458A 0 000847 A 2 0 00012160 Hc 2 FEF25 75 2 0828 0 03793A 0 00008572 Hc 2 FEF25 75 LLN 2 0828 0 037934 0 00003380 Hc 2 Mexican American Age 18 FEV1 0 9641 0 06490 A 0 000
45. A 0 013135 0 5962 0 12357A 0 013135 Technical References A 2 0 00014098 A 2 0 00011607 A 2 0 00018188 A 2 0 00015323 A 2 0 00018642 A 2 0 00015695 A 2 0 00024962 A 2 0 00017635 1 0863 0 13939A 0 00010345 Hc 2 1 0863 0 13939A 0 00005294 Hc 2 0 5536 0 013034 0 000172 0 5536 0 013034 0 000172 A 2 0 00014098 A 2 0 00011607 0 1102 0 00842A 0 000223 A 2 0 00018188 0 1102 0 008424 0 000223 A 2 0 00015323 0 1933 0 000644 0 000269 A 2 0 00018642 0 1933 0 000641 0 000269 A 2 0 00015695 1 05234 0 082722 0 001301 A 2 0 00024962 1 0523 0 082724 0 001301 A 2 0 00017635 2 7006 0 04995A 0 00010345 Hc 2 2 7006 0 04995A 0 00005294 Hc 2 0 7048 0 05711A 0 004316 0 7048 0 057114 0 004316 0 5525 0 141074 0 007241 0 5525 0 141074 0 007241 0 4971 0 154974 0 007701 0 4971 0 154974 0 007701 0 2684 0 280164 0 018202 0 2684 0 280164 0 018202 A 2 0 00013194 A 2 0 00010561 A 2 0 00016429 A 2 0 00013499 A 2 0 00016643 A 2 0 00013670 A 2 0 00027333 A 2 0 00018938 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 Hc 2 70 Technical References FEF25 75 1 1627 0 12314A 0 00010461 Hc 2
46. Do not attempt to lift or carry the spirometer by the pressure tube or power cord TheRenaissance Il system may be susceptible to radio frequency interference Refer to the electromagnetic interference section of this manual for more information Equipment Setup Cautions TheRenaissance Il Spirometry System and base station are designed for use only with the Puritan Bennett AC adapter P 495208 00 Do not connect AC Adapter P 495208 00 to an original Renaissance system PB 100 110 or damage will result Conversely do not connect a PB100 PB110 AC adapter P 062521 00 to the Renaissance Il Spirometry System e Prior to verifying calibration visually verify that there is no foreign material in the pressure tube and that the tube is not damaged or kinked 3 P 495220 00 Rev D Listing of Warnings Cautions and Notes CAUTION Battery Cautions The NiCad battery pack or other batteries may discharge over time Check batteries at least once per month for corrosion and verify batteries are fully charged Store spirometer in base station to keep unit ready for use Remove batteries if spirometer will not be used for at least two weeks Dispose of batteries properly Do not incinerate Puritan Bennett recommends that customers or technical service personnel follow local governing ordinances and recyding instructions regarding disposal or recycling of batteries Service Caution Do not remove the cover of the Renaissa
47. FEF25 75 LLN 1 1627 0 12314A 0 00004819 Hc 2 African American Age gt 20 FEV1 0 3411 0 02309A 0 00013194 Hc 2 FEV1 LLN 0 3411 0 02309A 0 00010561 Hc 2 FEV6 0 0547 0 02114A 0 00016429 Hc 2 FEV6 LLN 0 0547 0 02114A 0 00013499 Hc 2 FVC 0 1517 0 01821A 0 00016643 Hc 2 FVC LLN 0 1517 0 01821A 0 00013670 Hc 2 PEF 2 2257 0 040824 0 00027333 Hc 2 PEF LLN 2 2257 0 040824 0 00018938 Hc 2 FEF25 75 2 1477 0 042384 0 00010461 Hc 2 FEF25 75 LLN 2 1477 0 042384 0 00004819 Hc 2 Mexican American Age 20 FEV1 0 8218 0 04248A 0 004291 A 2 0 00015104 Hc 2 FEV1 LLN 0 8218 0 042484 0 004291 A 2 0 00012670 Hc 2 FEV6 0 6646 0 112704 0 007306 A 2 0 00017840 Hc 2 FEV6 LLN 0 6646 0 11270A 0 007306 A 2 0 00015029 Hc 2 FVC 0 7571 0 09520 A 0 006619 A 24 0 00017823 Hc 2 FVC LLN 0 7571 0 09520 A 0 006619 A 2 0 00014947 Hc 2 PEF 0 9537 0 19602 A 0 014497 A 24 0 00030243 Hc 2 PEF LLN 0 9537 0 19602 A 0 014497 A 2 0 00021833 Hc 2 FEF25 75 1 3592 0 105294 0 00014470 Hc 2 FEF25 75 LLN 1 3592 0 10529A 0 00009020 Hc 2 Mexican American Age gt 20 FEV1 0 6306 0 029284 0 00015104 Hc 2 FEV1 LLN 0 6306 0 029284 0 00012670 Hc 2 FEV6 0 5757 0 02860A 0 00017840 Hc 2 FEV6 LLN 0 5757 0 02860A 4 0 00015029 Hc 2 FVC 0 2376 0 008914 0 000182 A 2 0 00017823 Hc 2 FVC LLN
48. FVC 0 1889 0 0296A 0 0313Hc FVC LLN 0 718 FVC FEV1 2 6539 0 03974 0 0143Hc FEV1 LLN 0 726 FEV1 FEV3 1 633 0 023A 0 035Hc FEV1 113 694 0 2904A 5 4024FVC FEV1 LLN 0 854 FEV1 FEF25 75 6 3706 0 0615A PEF 0 735 0 025A 0 049Hc FIVC 0 1889 0 0296A 0 0313Hc FEVO S 0 406 0 014A 0 019Hc FEF50 6 2402 0 0755A 0 0118Hc FEF75 1 8894 0 0172A MVV 4 86957 0 685A 2 1384Hi Knudson 1976 Male Limits age 18 85 years height 58 80 inches Age 25 FVC 5 508 0 078A 0 050Hc FVC LLN 0 8150 FVC FEV1 4 808 0 045A 0 046Hc FEV1 LLN 0 8175 FEV1 FEV3 5 531 0 066A 0 052Hc FEV1 103 64 0 140A 0 087Hc FEV1 LLN 0 8762 FEV1 FEF25 75 5 334 0 059Hc PEF 8 060 0 166A 0 078Hc FIVC 5 508 0 078A 0 050Hc FEVO S 3 054 0 043A 0 030Hc FEF50 6 3851 0 1150A 0 0543Hc FEF75 4 2421 0 00574 0 0397Hc MVV 37 94893 0 81621A 3 02915Hi Age 2 25 FVC 5 459 0 029A 0 065Hc FEV1 4 203 0 027A 0 052Hc FEV3 5 245 0 031A 0 063Hc FEV1 103 64 0 140A 0 087Hc FEF25 75 1 864 0 031A 0 045Hc PEF 5 993 0 035A 0 094Hc FIVC 5 459 0 029A 0 065Hc FEVO S 2 746 0 017A 0 037Hc FEF50 5 5409 0 0366A 0 0684Hc FEF75 2 4827 0 0230A 0 0310Hc MVV 37 94893 0 81621A 3 02915Hi P 495220 00 Rev D Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976 Knudson et al 1976
49. MED TEST screen press 2 on the keypad or use the cur sor key to scroll to SVC and press ENTER 3 When prompted swipe the sensor or type the numeric code and press ENTER 4 Enter the room temperature and barometric pressure if necessary and press the DONE soft key The sensor will zero and the spirometer will dis play the SVC TEST screen and START TEST prompt Instruct the patient to e Place the sensor in his her mouth e Close lips and teeth around the sensor in such a way that a tight seal is formed Coach the patient enthusiastically Take a good deep breath Pull pull it all in Now exhale normally T hat s good Squeeze it out squeeze it all out Good job 5 The spirometer will display an SVC TEST U1JAN2000 12 00PM incentive message and the elapsed SE d time of the test while the real time sved 1120 1200 93 curve is drawn To display an incen tive bar graph instead of the real time curve press the INCENT soft key when the START TEST prompt Attempts 1 Volume 1 appears 6 Upon completion of the test maneu 3 Time S ver the spirometer will display the SAVE DISCARD volume time curve measured pre Figure 22 SVC Test Complete dicted and of predicted values and number of maneuvers performed Figure 22 7 Press the SAVE soft key if the maneuver is acceptable Press the DISCARD soft key if the maneuver is unacceptable The display retu
50. PURITAN BENNETT Renaissance II User s Manual 1 The user should read and understand all product literature labeling and warnings prior to operating the Renaissance Il Spirometry System To obtain information about warranty for this product contact Puritan Bennett Technical Support at 1 800 255 6774 Table of Contents Listing of Warnings Cautions and Notes 71 Indicators Symbols and Icons 7 Introduction to the Renaissance II Spirometry System 8 Feat 6 anda mene eden Aase arin et oro i E dune le NE Ow 8 Intended Use 35 24 04 kurerer Xu Re ee RE Dee at US 8 Basic Spirometry System and Accessories 9 Connecting the AC Adapter 9 Battery Operation amp cccrvet seat ae ct ie Renee a ea d Y eva EE 9 Connecting the Pressure Tube 11 Keypad Functions and Controls 13 Main Screen Icon Features 13 Initial Configuration 14 Spirometry Testing s ssssssrsss LD Introduction to Spirometry Testing 15 Obtaining Good Test Results 16 Pre Test Procedufes 22288 s aa ae xar
51. Pressure mm Hg 0 760 757 755 752 749 746 744 741 738 736 1000 733 730 728 725 722 720 717 714 712 709 2000 707 704 702 699 696 694 691 689 686 684 3000 681 679 676 674 671 669 666 664 661 659 4000 656 654 652 649 647 644 642 640 637 635 5000 632 630 628 625 623 621 618 616 614 611 6000 609 607 605 602 600 598 595 593 591 589 7000 586 584 582 580 578 575 573 571 569 567 8000 565 562 560 558 556 554 552 550 548 545 9000 543 541 539 537 535 533 531 529 527 525 10000 523 521 519 517 515 513 511 509 507 505 11000 503 501 499 497 495 493 491 489 487 485 12000 483 482 480 478 476 474 472 470 468 467 13000 465 463 461 459 457 456 454 452 450 448 14000 447 445 443 441 439 438 436 434 432 431 15000 429 The above values are estimates only Weather can change these values by 20 mmHg Thus this table does not replace a barometer mmHg Torr 1 ft 0 3048 m 1 m 3 281 ft Reference 1984 Intermountain Thoracic Pulmonary Function Testing Second Edition pg 183 Smithsonian 1963 Iribarne 1973 Reading the Barometric Pressure vs Altitude Chart The barometric pressure at your elevation can be read to the nearest 100 feet using the chart above The following example shows how to find the barometric pressure at an altitude of 4700 feet 1 2 87 Find the row corresponding to 4000 feet in the vertical altitude column at the left side of the graph Find the column corresponding to 700 feet in the
52. R Figure 9 On the SSD CAL screen verify that the temperature and barometric pressure are correct If not scroll to the corresponding field and type the correct information using the numeric keypad before swiping the sensor Figure 10 Use the cursor key to scroll to the sensor code field and swipe the sen sor Figure 11 or enter the numeric code and press the DONE soft key Continue to follow the screen s directions when prompted Push the 3 Liter syringe plunger in smoothly over a period of approxi mately one second for the 3 L sec verification The dotted lines appearing on the display represent the upper and lower limits for the flow rate While pushing the plunger in the graph will develop on the display Try to keep the graph within the dotted lines The SSD CAL screen will prompt faster slower if necessary Figure 12 Repeat until you are prompted to proceed Press the Y ES soft key to proceed with the 1 L sec verification and fol low the same procedures as before 01JAN2000 12 00PM 65 00 40YRS PRE MED TEST 01JAN2000 12 00PM F 40YRS 65 00 Figure 9 Select SSD CAL from PRE MED TEST screen SSD CAL 01JAH2000 12 00PM SWIPE SENSOR OR ENTER CODE Sensor Code 0 Temperature 2F Baro Pressure 760mmHg Figure 10 Enter room temperature and barometric pressure steps 6 through 7 when prompted on the screen for the next calibration maneuver Push the 3 Liter syringe
53. R OUT THEN PRESS PROCEED PROCEED CANCEL swipe Figure 15 Attaching syringe CAL CHECK 01JAN2000 12 00PM FOR EXPIRATORY OHLY PRESS DONE OR FOR INSPIRATORY CAL PULL PLUNGER OUT DONE CANCEL Figure 16 Calibration check NOTES The ATS does not require an Inspiratory Calibration The Renaissance II s Inspiratory Calibration function has been validated only for elevations below 4000 feet P 495220 00 Rev D CAL CHECK 01JAH2000 12 00PM Calibration Check Time 01JAN2000 12 00PM Syringe Volume 3 00 Expired Volume 3 09 Expired Error 3 0 Inspired Volume 2 92 Inspired Error 2 8 DONE DISCARD PRINT Figure 17 Cal Check complete 22 Pre Test Procedures Patient Preparation Coaching the patient will result in more accurate results There are several possible reasons why accurate results are not obtained the first time e Not taking a maximal inhalation at the beginning of the maneuver e Not blasting the air out quickly or starting slow e Not blowing out completely Physicians should assess patient s ability to perform spirometry A testing prior to administering the test Patient fainting or falling due to dizziness may occur as a result of this test Advise the patient to sit or stand comfortably near a chair during test User should visually inspect the FSII sensor for loose particles foreign material prior to patient use NOTES
54. a particular test and for evaluating and improving the coaching abilities of test technicians The test grades are A B C D and F For specific grading criteria used by the Renaissance II refer to the Grading Criteria section on page 44 Lung Age If the lung age calculation option is enabled and the patient s smoking history has been entered the patient s lung age will be calculated See Lung Age Interpretation on page 47 for more information on lung age COPD Risk If the COPD risk option is enabled and the patient s smoking history has been entered the risk of COPD will be calculated See Risk of COPD on page 47 for more information Values Soft Key By pressing the VALUES soft key you can choose which spirometry parameters you want to include on printed reports where you have specified the User Defined format in the Print options see Print Options 3 on page 80 If you have previously specified the Clinical or Industrial print option and you select any or all of the following parameters the print option automatically changes to User Defined FEV3 FEF25 75 FET FEF25 PEF FEF50 PIE FEF75 FEF50 FIF50 79 P 495220 00 Rev D System Configuration Device Options 2 Custom H eader This configuration allows you to generate a custom header on each page of the printed report The custom header will appear centered at the top of each page The header can consist of up to two lines and each line can have up to 20 character
55. age is displayed at the end of the maneuver If a different message is displayed use the associated coaching instruction in Table 5 to try to improve the patient s test outcome The Renaissance II measures reproducibility also called variability after at least two repetitions of a particular maneuver have been performed and displays the measurements on the screen and in printed reports as FVC VAR and FEV1 VAR Results are considered reproducible if the two largest FVC and FEV1 measurements are within 200 ml of each other According to the ATS testing may be concluded when at least 3 acceptable and 2 reproducible spirograms have been obtained or when a total of eight tests have been performed or the patient cannot or should not continue To view the number of acceptable and reproducible tests 1 Make sure the spirometer is configured so that acceptability and reproduc ibility options are enabled see the System Configuration section starting on page 78 to configure Spirometry Options 2 From the M AIN screen press 3 on the keypad or scroll to VIEW with the cursor arrow key and press ENTER The SELECT VIEW screen appears 3 From the SELECT VIEW screen press 2 or scroll to SUM M ARY with the cursor arrow key and press EN TER The number of acceptable and reproducible tests is shown in the display If Accept Msgs is enabled in the Print Options screen the Acceptability Message will print on the test page if the LAST t
56. arranty Each Renaissance II spirometer and base station is manufactured and recorded with an individual serial number The serial number is located on a label attached to the underside of the unit Please reference this information when contacting Puritan Bennett NOTE The serial numbers are located on a label affixed to the underside of the spirometer or base station The first letter G represents the manufacturer The next two numbers represent the year of manufacture The two digits following the year represent either a base station 08 or a spirometer 07 The last five digits are sequential numbers assigned during manufacture P 495220 00 Rev D 56 Technical References Technical References Table 9 Product Specifications Renaissance II Spirometer Dimensions 5 75 H x 7 5 W x 2 25 D Weight 18 ounces Accuracy Validated to comply with American Thoracic Society Standards for Spirometry 1994 D Volume 3 of reading or 50 ml whichever is greater FEV1 FEV3 and FEV6 measured by back extrapolation PEF 10 of reading or 0 40 L sec whichever is greater FEF25 75 or MMEF 5 of reading or 0 20 L sec whichever is greater Volume Range 0 12 Liters BTPS Flow Range x16 Liters sec Resistance Less than 1 5 cm HO Liters sec from 0 12 Liters sec Test Time SVC FVC FVL 30 seconds MVV 15 seconds Display 3 1 x 2 4 viewable area 78mm x 61mm 320 x 240 do
57. atient setup NOTE Setup locations 6 7 and 9 are not used Storage 8 Confirm Before D elete Turning this option on requires the user to press the YES or NO soft key before patient records are deleted See Deleting Patient Data on page 41 for more information Compress Curve Data With this option enabled graphical data is compressed so that memory capacity is approximately doubled 83 P 495220 00 Rev D The following table lists the factory defaults and possible settings for all configuration options System Configuration Table 13 Setup and System Configurations Configuration O ption Factory Alternate Settings Defaults Spirometry O ptions Interpretation ATS Enright None Adult Normals Knudson 83 Morris Knudson 76 Crapo Morris NHANES III Pediatric Normals Hsu Polgar Dockery NHANES III Reproducibility ON OFF Acceptability ON OFF Best Criteria VAL SUM ENRIGHT QC Grades ON OFF Lung age ON OFF COPD Risk ON OFF Device O ptions Header None User specified Units NON METRIC METRIC cm kg m in lbs ft PEF Units L Sc L M Clock 12 HR 24 HR Elevation 0 0 15 000 ft Audio ON OFF Audio incent ON OFF Offset Curves ON OFF P 495220 00 Rev D 84 System Configuration Table 13 Setup and System Configurations cont Configuration O ption Fa
58. be changed and the spirometer will continue to use the value entered e f you choose to obtain barometric pressure from an agency such as the weather service verify that the value is NOT corrected to sea level Instruct the patient to Place the sensor in his her mouth Close lips and teeth around the sensor in such a way that a tight seal is formed Coach the patient enthusiastically Take a good deep breath Pull pull it all in Now BLAST out Keep blowing harder T hat s good Squeeze it out and suck it back in deep deep G ood job P 495220 00 Rev D 30 Pre Med Testing Procedures D 10 31 When the spirometer detects that the expiratory portion of the maneuver is complete the incentive message will change to Deep Breath In Instruct the patient to inhale as quickly and fully as possible The spirometer will continue to display an incentive message and the elapsed time of the test while the real time curve is drawn To display an incentive bar graph instead of the real time curve press the INCENT soft key when the START TEST prompt appears Upon completion of the test maneu pyrresT TITANITTT TITT UPM ver the spirometer will display the ANE DOE EU MERE da FVC L 3 68 ow flow volume curve measured val FEV1 L son FEY 19 ues quality message quality grades ber pd FIVC L 3 89 number of maneuvers performed dez L2 LUE and FVC and FEV1 variability 4 Figure 2
59. ces section starting on page 60 P 495220 00 Rev D 78 System Configuration Reproducibility Turning this option on displays the number of reproducible tests performed by the patient when the SUMMARY option is selected from the VIEW menu or when a report is printed Acceptability Turning this option on displays the number of acceptable tests performed by the patient when the SUMMARY option is selected from the VIEW menu or when a report is printed Best Criteria This setting determines how the values for the best test are chosen The three options are Val Sum and Enright The definition of each option is as follows Val includes the best values of FVC and FEV1 from any acceptable test The remainder of the values will be taken from the maneuver with the highest sum of the FVC and the FEV1 Sum uses the values of FVC and FEV1 for the single maneuver with the highest sum of the FVC and the FEV1 Enright uses the values of the single test with the highest sum of the FVC the FEV1 and 1 2 PEF NOTE The Val best value method is recommended by the American Tho racic Society and mandated by NIOSH OSHA standards and should be used for all industrial and disability testing QC Grades This setting determines whether the display and printed reports Best and Best 3 only will include the test quality grades The grades for FVC FEV1 and FEV6 FEV1 tests are useful in judging the reliability of
60. ctory Alternate Settings Defaults Print O ptions Printer HP DJ B amp W HP DJ Col HP Laser Epson B amp W Epson Col Canon B amp W Paper 8 5 X11 A4 Format Clinical Industrial User Defined Accept Msgs ON OFF Interpretation ON OFF Predicteds Curve Points None Graph Both VT FV None Grid ON OFF Size VAL DIAG Scale 1X AUTO All Curves ON OFF Settings O ptions Language Date Time Elevation Display O ptions Autoscale Graphs ON OFF Predicted Curve Points None Show Patients By ID Name Storage O ptions Confirm Before Delete ON OFF Compress Curve Data ON OFF 85 P 495220 00 Rev D System Configuration Printing the System Configuration Perform the following steps to print the spirometer s setup and system configuration 1 From the M AIN screen press 6 on the keypad or use the cursor arrow key to scroll to PRIN T and press ENTER 2 From the SELECT REPORT screen press 3 on the keypad or use the cursor arrow key to scroll to SET UP and press ENTER The configuration report is sent to the printer NOTE Keep the System Configuration printout available for future reference You may use it to return the Spirometer to its previous setup configuration if settings are changed P 495220 00 Rev D 86 System Configuration Barometric Pressure vs Altitude Table 14 Barometric Pressure vs Altitude Altitude i Feet 0 100 200 300 400 500 600 700 800 900 i Barometric
61. culated by substituting the predicted value of FEV1 with the smoker s actual FEV1 Then the FEV1 predicted equation is solved for age The reported lung age value will never be less than 25 or less than the patient s actual age It should be emphasized that the lung age parameter is intended to be used solely as a smoking cessation tool and not as a diagnostic measurement NOTE Entering a smoking cessation date will eliminate the lung age value Risk of COPD The risk of COPD expresses the probability expressed as a percentage that the patient will develop Chronic Obstructive Pulmonary Disease COPD within the next 10 years and also provides an indication of the risk if the patient were to quit smoking If the option is enabled the COPD risk appears on the Summary screen by pressing the RISK soft key and on the printed report if the patient s age and smoking history were entered during new patient setup see System Configuration and Spirometry Options 1 starting on page 78 for information on how to enable the Risk of COPD option The risk of COPD is calculated using the patient s age cigarettes smoked per day measured FEV1 and predicted FEV1 as variables substituted into the equations documented in the article Risk of Chronic Obstructive Pulmonary Disease NOTE The risk of COPD is calculated only for patients 64 years and younger 47 P 495220 00 Rev D Graphic Displays Spirometry maneuvers are usually illus
62. d curves are shown regardless of whether the All Curves option is turned on or off If there are no Post Med tests the three best FVC VFL and FEV6 curves will print regardless of the All Curves option setting P 495220 00 Rev D 82 System Configuration Settings 4 Language Allows you to select the language in which the information will be displayed and printed Date Allows you to enter the day month and year using the numeric keypad Time Allows you to enter the time using the numeric keypad The time will display in 12 hr am pm or 24 hr time depending upon your selection in the device setup see Device Options 2 Elevation This setting allows the user to enter altitude above sea level The elevation is from 0 15 000 feet or 4572 meters This setting allows the spirometer to determine the BTPS correction factor Display 5 Autoscale G raphs When this option is off volume time and flow volume graphs are displayed at a fixed size Turning this option on allows the display to automatically scale the volume time and flow volume graphs based upon the amount of stored data up to twice the size of the fixed size graph Predicted This setting allows you to choose how you want the unit to display predicted values on the screen The options are curve points and none See Print Options 3 for more information Show Patients By This setting allows you to display patient data using the ID number or name entered during new p
63. d from the Renaissance II spirometer via a null modem cable connected between the PC and the spirometer base DataFlow software allows you to Examine trends in patient pulmonary function Update the spirometer with changes to patient data Print reports from your computer Query the database Archive data in a database Contact Puritan Bennett Customer Service at 1 800 635 5267 to purchase DataFlow M Data Management Software 77 P 495220 00 Rev D System Configuration System Configuration The Renaissance II Spirometry System offers a wide range of configuration options that allow you to customize the operation and printed reports The Renaissance II is preset at the factory with a default configuration These settings can be easily changed This section describes each configuration option To view or change configuration settings 1 From the M AIN screen press 9 on the key pad or scroll to SET UP using the cursor key and press ENTER 2 Press the appropriate number on the key pad or scroll to the item whose options you want to change and press ENTER The current configuration and options are displayed 3 Use the cursor arrow to tab to the selection Enter the desired setting and press ENTER You may change other settings or return to the SET UP menu by selecting DONE When you have completed all of your changes select DONE to return to the M AIN screen The following sections describe each configuration option and
64. e test while the real time curve is being drawn The patient should keep blowing until the TEST COM PLETE message appears To display an incentive bar graph instead of the real time curve press the IN CENT soft key when the START TEST prompt appears 6 Upon completion of the test the spirometer will display the flow volume curve measured values acceptability messages quality grades number of maneuvers performed and FVC and FEV1 variability depending on the options enabled during system configuration Figure 21 To view the vol ume time curve press the VT soft key To view the results as a percentage of the predicted values press the PRED soft key 7 Press the SAVE soft key if the maneuver is acceptable Press the DISCARD soft key if the maneuver is unacceptable The display returns to the PRE MED TEST screen 8 Select FVC again and repeat the above process up to eight times until at least three acceptable and two reproducible maneuvers have been obtained NOTE The value for FEV6 can only be obtained by administering an FEV6 test P 495220 00 Rev D 28 Pre Med Testing Procedures SVC Slow Vital Capacity Test Procedure Patient fainting or falling due to dizziness may occur as a result of this A test Advise the patient to sit or stand comfortably near a chair during test 1 From the M AIN screen press 2 on the keypad or scroll to TEST using the cursor key and press ENTER 2 From the PRE
65. ess the 0 key to power up the spirometer The spirometer will display an introductory screen while a self test is performed Press the PROCEED soft key to go to the next screen Figure 6 NOTE The date of the last valid calibration check will display as part of the spirometer s power up sequence if a calibration check has not been performed in the current calendar day 2 Inthe INITIAL SETUP screen the user is prompted to select certain con figurable options This screen will be displayed each time the spirometer is powered up until the user sets the displayed options Figure 7 3 Using the cursor key highlight each option and enter the desired settings using the keypad Press the DONE soft key to go to the M AIN screen Figure 5 NOTE For test accuracy elevation must be entered 4 From the MAIN screen adjust the display appearance by pressing the LIGHTER DARKER and BACKLIT soft keys to the desired settings P 495220 00 Rev D 14 Spirometry Testing Spirometry Testing Introduction to Spirometry Testing The purpose of a spirometry test is to assess and monitor a patient s lung condition The most common spirometry test is the Forced Vital Capacity FVC test This test requires the subject to take a deep breath and then exhale into the spirometer as forcefully rapidly and completely as possible The FVC test results report how fast the air was exhaled flow rate and how much air was e
66. est is selected for printing see the System Configuration section starting on page 78 to configure Spirometry and Print Options and Printing Results on page 38 for information regarding printing reports P 495220 00 Rev D 42 Interpretation of the Results Table 5 Test Acceptability Messages Message Definition Coaching Instruction START Extrapolated volume is greater than 5 Patient must not hesitate or leak out FASTER of FVC or greater than any air at the beginning of the test 150 ml 5 if FVC gt 3 liters 150 ml if FVC 3 liters AVOID Substantial gt 50 drop and recovery Ask the patient to clear his her throat COUGHING in flow within the first second and or offer a drink of water BLOW OUT FET lt 6 seconds for FVC maneuvers or Coach the patient to blow out longer LONGER FET 6 seconds and exhaled volume in last 0 5 second of test gt 100 ml for FEV6 maneuvers BLOW OUT Flow gt 200 ml s during last 100 ms The patient quit before his her lungs MORE before first occurrence of peak volume were completely empty Coach the or 2 s plateau time from end of test to patient to keep blowing as long as first occurrence of peak volume 20 ml possible BLOW OUT Time to PEF gt 120 ms for FEV6 Instruct the patient to blast out air HARDER maneuvers only forcefully FVC There is a difference of at least 200 ml Observe patient performance for VARIABLE between the t
67. f the battery is removed the unit will operate solely on AC power if connected to an electrical outlet via the AC adapter CAUTION Dispose of batteries properly Do not incinerate Puritan Bennett recommends that customers or technical service personnel follow local governing ordinances and recycling instructions regarding disposal or recycling of batteries The NiCad battery pack or other batteries may discharge over time Check batteries at least once per month for corrosion and verify batteries are fully charged Store spirometer in charging base station to keep unit ready for use Remove batteries if spirometer will not be used for at least two weeks P 495220 00 Rev D 50 Troubleshooting Guide Troubleshooting Guide Unit powers up while on AC power but not battery power 1 Verify that batteries are installed properly and properly charged 2 Verify batteries are less than one year old Replace batteries at least once per year NOTES e The Renaissance Il Spirometry System is designed to recharge only the custom battery pack supplied with the system and will not recharge batteries from other manufacturers e When there is a low battery condition the Renaissance Il spirometer beeps every 30 seconds and displays a low battery icon 3 Batteries may be low Replace or recharge the custom battery pack 4 Contact Puritan Bennett Technical Support if results are unsuccessful Unit does not powe
68. ficient or convenient 1 P 495220 00 Rev D Listing of Warnings Cautions and Notes The user should read and understand all product literature labeling and warnings prior to operating the Renaissance II Spirometry System Patient Safety Warnings This device should be used by trained healthcare professionals and is not intended for patient operation Physicians should assess patient s ability to perform spirometry testing prior to administering the test Patient fainting or falling due to dizziness may occur as a result of this test Advise the patient to sit or stand comfortably near a chair during test Patient Data Warnings e Predicted values will be extrapolated for patients with age or height outside the age and or height limits supported by the selected author s normal equations Results from spirometry testing should not be the sole source for determining a patient s diagnosis and treatment Other clinical data such as patient symptoms and respiratory history should always be considered Use Environment Warnings TheRenaissance Il Spirometry System is not intended for use in an oxygen enriched atmosphere or in the presence of flammable anesthetics To avoid risk of electrical shock this unit should only be used in dry locations Equipment Setup Warnings e As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation When co
69. g determines whether there will be grid lines on the graphs The grid lines may make it easier to read test values from the curves The grid lines are required for disability testing Size The graph size setting allows you to choose the size of graphs that appear on the printed report The options are validation size and diagnostic size Validation size graphs are larger in scale and are designed to allow hand validation of test values Due to its large size a printed report with validation size graphs may require more than one page All occupational and disability testing should use the validation size Diagnostic will usually allow the entire report to be printed on a single page unless an SVC or MVV test is performed Scaling information is printed with all graphs Scale This setting determines whether to automatically scale the graph size up during printing based on the size of the FVC FVL curves stored Auto option or whether to leave the graph size fixed 1x option All Curves Printing a Best or Best 3 report with this option turned on will show the best three flow volume and volume time graphs for each Pre Med and Post Med FVC FVL and FEV6 maneuver performed in a patient s session If this option is turned off only the single best Pre Med and Post Med flow volume and volume time graph for FVC FVL and FEV6 tests will print If SVC and MVV maneuvers have been performed in the same session only the single best Pre Med and Post Me
70. horizontal altitude row at the top of the graph Read the barometric pressure 640 mm Hg at the point where the row and column intersect P 495220 00 Rev D Glossary of Medical Terminology Glossary of Medical Terminology AT PD Ambient temperature pressure dry AT PS Ambient temperature pressure saturated with water vapor AT PS to BT PS Conversion Factor A factor used to convert flow and volume data from values measured at ambient temperature ATPS to body temperature BTPS ATS American Thoracic Society http www thoracic org Back Extrapolated Start T ime In order to measure the timed parameters more accu rately and consistently the ATS recommends using a technique called back extrapola tion to determine the start of maneuver The Renaissance II spirometer uses this technique For more details please reference Standardization of Spirometry 1994 Update ATS BT PS Body temperature 37 C pressure saturated with water vapor CSA Canadian Standards Agency Extrapolated Volume The amount of air exhaled prior to the back extrapolated start time If this volume is more than 5 of the FVC the maneuver started too slowly This is also known as BEV Back Extrapolated Volume FEF 25 75 The mean flow rate between 25 and 75 of the Forced Vital Capacity This is also known as MMEF Mean Mid Expiratory Flow FEF50 FIF50 Ratio of Forced Expiratory Flow at 50 of FVC to Forced Inspira tory Flow at
71. hysiological variant is interpreted as Undetermined in the Renaissance II if FVC and FEV1 are greater than 100 and FEV1 is less than 100 If the FEV1 FVC ratio FEV1 is below the lower limit of the normal range the patient is identified as having airway obstruction The degree of obstruction is then determined by the amount of reduction in the FEV1 value If the FVC is also reduced in a patient with an obstruction a superimposed restriction cannot be ruled out P 495220 00 Rev D 46 Interpretation of the Results When the FVC is below the lower limit of normal and the FEV1 is normal the patient may have a restrictive disorder The degree of restriction can be determined by the amount of reduction in the FVC Note that a low FVC is often due to poor patient effort If both the FVC and FEV1 are within the normal range the spirometry is considered to be normal NOTE Refer to Predicted Normal Equations and References on page 60 for further explanation Lung Age Interpretation Lung age is a smoking cessation tool that if the option is enabled appears on the Summary screen by pressing the RISK soft key and on the printed report see System Configuration and Spirometry Options 1 starting on page 78 for information on how to enable the Lung Age option The patient s lung age will be calculated if you have entered the patient s smoking history and the patient s actual age is 20 to 84 years The lung age value is cal
72. ient inhale maximally and exhale forcefully and completely with mouth and teeth firmly sealed around the mouthpiece Watch and listen for the incentive display e If the test is unacceptable identify the reason s and explain how to correct the technique e Obtain at least three acceptable and two reproducible tests See pp 1122 1123 of Reference 11 page 91 for ATS acceptability and reproducibility criteria If tests are below normal consider administering a bronchodilator according to office protocol then retest in 10 to 15 minutes or as suggested by the physician As the test is performed coaching messages or incentive messages e g Start Test Keep Going appear on the display to encourage the patient Depending on the user s preferences a graph of the data or an animated incentive will be displayed during the test These messages and graphics should be used to coach the subject to perform the test maximally This device should be used by trained healthcare professionals and is not intended for patient operation P 495220 00 Rev D 16 Pre Test Procedures Pre Test Procedures Calibration Verification The American Thoracic Society ATS recommends that a three speed calibration verification using a calibrated syringe with a minimum volume of 3 liters be performed on a daily basis to verify the accuracy of the system prior to testing patients Puritan Bennett recommends using the 3 liter calibrated syri
73. input To bring back the display before the 30 minute limit press any key DONE e After 4 hours a Post Med test is not allowed and the soft key is not available Figure 27 Post Med Test Screen To retrieve a patient s session from memory 1 From the M AIN screen press 7 or scroll to FIN D using the cursor key 2 Type the patient s name or ID number depending upon the spirometer s Display configuration in the FIND PATIENT field or press the SCROLL soft key and use the cursor arrow to select the patient s name or ID number See System Configuration on page 78 and Display 5 on page 83 for information on how to configure the unit to show patients by name or ID 3 Press the following soft keys in order MARK gt CURRENT gt BACK gt RECALL The spirometer is now ready to switch to Post Med test mode To switch to Post Med test mode and perform Post Med testing 1 From the PRE M ED TEST screen press the POST soft key The CHANGE TO POST M ED TEST MODE message Figure 26 appears 2 Press the Y ES soft key The display heading changes to PO ST M ED T EST Figure 27 and the test options appear just as they did for the PRE MED TEST screen The only test options appearing on the PO ST M ED TEST screen are those previously performed in Pre Med testing 3 Proceed as described in the Pre Med testing section of this User s Manual for each test 35 P 495220 00 Rev D Post Test Procedures
74. ion setting of the spirometer However the barometric pressure may be changed and the spirometer will from that point on use the new value entered e If you choose to obtain barometric pressure from an agency such as the National Weather Service verify that the value is NOT corrected to sea level 5 Perform a calibration check using the sensor that the patient tested with Make a note of the results 6 Contact Puritan Bennett Technical Support if results are unsuccessful If the values are unusually low 1 Check flow sensor and pressure tube for leaks 2 Verify patient is not leaking air from mouth or nose Use nose clips 3 Verify patient is tightly closing lips and teeth around the outside of the sensor NOTE Obstructing sensor opening with teeth lips or tongue while performing the test will cause low readings 4 Perform a calibration check using the flow sensor that the patient tested with Make a note of the results 5 Contact Puritan Bennett Technical Support if results are unsuccessful NOTE Replace the pressure tube every year 53 P 495220 00 Rev D Troubleshooting Guide Unable To Print Test Results 1 Verify that the printer is turned on and is online and ready 2 Print a test page to ensure the printer is working properly If the problem seems to be isolated to the printer contact the printer manufacturer for technical support 3 Verify that the proper printer has been selected in
75. l 1981 Crapo et al 1981 Cherniack et al 1972 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983 Technical References 66 Technical References Age gt 25 PEF 5 993 0 035A 0 094Hc FEF50 5 5409 0 03664 0 0684Hc FEF75 2 4827 0 0230A 0 0310Hc Crapo FEMALE Limits age 18 89 years height 57 70 inches FVC 3 590 0 0216A 0 0491Hc FVC LLN FVC 0 676 FEV1 1 578 0 0255A 0 0342Hc FEV1 LLN FEV1 0 561 FEV3 2 745 0 02574 0 0442Hc FEF25 75 2 683 0 0460A 0 0154Hc FEV1 126 58 0 2520A 0 2020Hc FEV1 LLN FEV1 9 06 FEVO S 0 809 0 0185A 0 0238Hc FIVC 3 590 0 0216A 0 0491Hc MVV 4 86957 0 685A 2 1384Hi Age 20 PEF 3 916 0 1574 0 049Hc FEF50 2 3040 0 1111A 0 0288Hc FEF75 4 4009 0 29234 0 0243Hc 0 0075 A 2 Age2 20 and lt 70 PEF 0 735 0 025A 0 049Hc FEF50 0 4371 0 0240A 0 0321Hc FEF75 0 1822 0 02544 0 0174Hc Age 2 70 PEF 0 735 0 025A 0 049Hc FEF50 6 2402 0 0755A 0 0118Hc FEF75 1 8894 0 0172A Hsu MALE Limits age 7 17 years height 43 75 inches FVC 3 58 10 7 Hc 3 18 FVC LLN FVC 1 0 0 13 42 FEV1 7 74 10 7 Hc 3 00 FEV1 LLN FEV1 1 0 0 13 2 FEF25 75 1 33 10 5 Hc 2 46 PEF 5 58 10 6 Hc 2 79 FEV1 PRED FEV1 PRED FVC 100 FEV1 LLN 0 90 FEV1 FIVC 3 58 104 7 Hc 3 18 67 Knudson et al 1976 Knudson et al 1983 Knudson et al 1983
76. l patient records press the ALL soft key To select all records that have been added or changed since last P 495220 00 Rev D 40 Post Test Procedures printed or downloaded to a PC press the NEW soft key When you have finished selecting records press the BACK soft key 7 Press the NEXT then PRINT soft keys The best Pre Med and Post Med result for each maneuver performed in a patient s session is printed Deleting Patient Data The Renaissance II spirometer can store data for up to 1000 patients When the memory becomes full or if the unit is sent in for repair or exchange it may become necessary to erase patient data NOTE In order to comply with HIPAA the user should consider deleting all patient data prior to sending the unit to Puritan Bennett To delete patient data 1 From the M AIN screen press 7 on the keypad or use the cursor arrow key to scroll to FIN D and press ENTER 2 Press the SCROLL soft key 3 Use the cursor arrow key to highlight the patient to be deleted If you want to delete all patient data highlight any patient 4 Press the MARK soft key 5 Usethe CURRENT or ALL soft keys to delete either the highlighted patient or all patient data Press the BACK soft key Press the N EXT soft key Press the DELETE soft key A confirmation screen appears if this option has been enabled see System Configuration on page 78 and Storage 8 on page 83 for information on changing the spirometer s c
77. llation instructions If NiCad cells are used an external charger is required NOTES e The custom battery pack must be charged at least 24 hours before portable use e The Renaissance II Spirometry System is designed to recharge only the custom battery pack supplied with the system and will not recharge batteries from other manufacturers P 495220 00 Rev D CAUTION A The Renaissance II Spirometry System and Base Station are designed for use only with the Puritan Bennett AC adapter P 495208 00 Do not connect AC Adapter P 495208 00 to an original Renaissance system PB100 PB110 or damage will result Conversely do not connect a PB100 PB110 AC adapter P 062521 00 to the Renaissance II Spirometry System ig LA u NF Pressure Tube Figure 3 Setting up the System 10 Introduction to the Renaissance Il Spirometry System The custom NiCad battery pack has a battery life of 10 12 hours in the ON position and a battery life of approximately 8 days in the OFF position The pre installed custom NiCad battery pack will continuously charge as long as power is connected to the spirometer through the AC adapter During operation the Renaissance II spirometer continually checks battery status A low battery indicator will appear in the right hand corner of the screen when fewer than 20 patient tests can be performed If the battery voltage drops below a reliable operating level the unit will shu
78. measured in liters sec Also called FIF max Restrictive D isease These diseases are characterized by reduced lung volume or impaired movement of the lungs A lowered FVC with normal FEV1 and FEV1 FVC or FEV is often an indication of restrictive disease although a poor patient effort is also a common cause of lowered FVC Restrictive disease includes gross obesity lung fibrosis neuromuscular disease or paralysis as well as several occupational related diseases such as pneumoconiosis and cotton dust lung 89 P 495220 00 Rev D Glossary of Medical Terminology RR Respiratory Rate or BPM Breaths Per Minute The frequency of breaths during an MVV maneuver Also called the MVV Rate SVC Slow Vital Capacity The total amount of air that can be slowly exhaled from full inspiration Also called the Vital Capacity or VC U ndetermined An interpretation result generated by the Renaissance II when the FVC and FEV1 are greater than 100 and FEV1 is less than 100 of the predicted val ues VC Vital Capacity Same as SVC Volume T ime Curve A graphic printout of an FVC and SVC or MVV maneuver show ing volume vs time P 495220 00 Rev D 90 References References 1 10 11 12 13 14 15 16 17 91 Cherniack R M Raber M B Normal Standards for Ventilatory Function using an Automated Wedge Spirometer American Review of Respiratory Disease 1972 106 38 46 Crapo Robert O et al
79. medication comparison graphs will not be offset Print Options 3 Printer The Renaissance II Spirometry System operates with a variety of parallel printers that use the Hewlett Packard graphic languages as well as several other printer protocols The following list indicates some of the printer types that are supported Contact Puritan Bennett Technical Support for the printers and model numbers currently supported e HPDJ Black amp White Color and Laser Epson Black amp White Color e Canon Black amp White Paper This setting allows you to choose the printer paper size The options are 8 5 x 11 or A4 International Standard paper size P 495220 00 Rev D 80 System Configuration Format You can choose between Clinical Industrial or User Defined formats for printing test results Table 12 shows the information printed for each test performed If you select either the Clinical or Industrial print option and later change the marked selections using the VALUES soft key in Spirometry Options see Spirometry Options 1 on page 78 the print format will automatically change to User Defined Table 12 Printed Values for Specified Print Format Options Test Performed Print Format O ption Clinical Industrial User Defined FVC FVC FEVI1 FVC FEV1 FVC FEV1 FEV1 FEF25 75 FEV1 FEV1 FEV3 FET PEF FET PEF FEF25 75 FEF25 FEF50 FEF75 FVL FIVC PIF FEF50 FIVC FIVC PIF
80. metric pressure or elevation for your location is entered 3 Ifthe percent error reading is 3 or less check the system for leaks Examine the pressure tube for any small punctures Check syringe sensor and pressure tube for loose connections 4 Ifthe percent error is 3 or more examine the flow sensor for foreign material contamination of the resistance medium 5 Contact Puritan Bennett Technical Support if results are unsuccessful NOTE Replace the pressure tube every year Recertify 3 liter syringes once per year Error Zeroing Sensor is displayed in the message window 1 Movement sensed during zeroing Place the sensor and pressure tube on the table top and repeat the procedure 2 Disconnect the pressure tube from the spirometer and rezero If the spirometer zeroes without the pressure tube connected the pressure tube may be defective Examine pressure tube for moisture or other obstruction in the clear portion of the tube 3 Contact Puritan Bennett Technical Support if results are unsuccessful NOTE Replace the pressure tube every year Error Sensing Blast Out is displayed in the message window 1 No exhalation was sensed within 20 seconds Repeat the test 2 Verify that the pressure tube is connected 3 Examine pressure tube for damage 4 Contact Puritan Bennett Technical Support if results are unsuccessful NOTE Replace the pressure tube every year Spirometer auto senses spiromete
81. nce Il Spirometry System or base Removal of the cover is permitted only by qualified service personnel There are no user serviceable parts inside Do not spray liquids on the Renaissance II System Follow the cleaning instructions outlined in the Service and Maintenance section starting on page 49 of this manual Flow Sensor Cautions Use only the FSII flow sensor specifically designed for the Renaissance Il Spirometry System The FSII sensor is for single patient use only In the interest of environmental protection dispose of all sensors and nose clips properly Notes Accuracy Notes e For test accuracy elevation must be entered Verify that the displayed barometric pressure is correct If not correct there will be an error in the inspired volume FIVC during an FVL maneuver of approximately 1 3 for every 1 000 feet above sea level Refer to the System Configuration section starting on page 78 for more information The barometric pressure displayed is based on the initial elevation setting of the spirometer However the barometric pressure may be changed and the spirometer will from that point on use the new value entered f you choose to obtain barometric pressure from an agency such as the National Weather Service verify that the value is NOT corrected to sea level P 495220 00 Rev D 4 Listing of Warnings Cautions and Notes Notes Calibration Notes The date of the last valid calib
82. nfiguration as indicated on page 86 to ensure no settings are lost Contact Puritan Bennett Technical Support at 1 800 255 6774 for information regarding cross contamination studies performed on the flow sensor and pressure tube 49 P 495220 00 Rev D Service and Maintenance Use the following procedure to install or replace the battery 1 e If the AC adapter is connected to the spirometer remove the connector from the spirometer Remove the battery door Figure 32 by pressing the tab on the front of the battery door and pulling the door off Remove the used NiCad battery pack by disconnecting the con nector and lifting the batteries out gently Insert a new battery pack according to the illustration on inside of the case and plug in the connector Figure 32 Battery Installation After the batteries have been replaced reinstall the battery door Charge the battery for at least 24 hours before portable use Compare the System Configuration with your print out to ensure settings are appropri ate see page 78 for System Configuration information The custom NiCad battery pack has a battery life of 10 12 hours in the ON position and a battery life of approximately 8 days in the OFF position Standard AA Alkaline or NiCad batteries may be used instead of the custom battery pack supplied with system However the Renaissance II will only charge the custom NiCad battery pack supplied with the unit NOTE I
83. nge specified in Table 1 Basic Spirometry System and Accessories optional accessory item 12 see page 9 for verifying the calibration of the Renaissance II The syringe should be recertified for volume accuracy and leaks per manufacturer recommended intervals The Renaissance II can perform two types of calibration verifications SSD and Cal Check The SSD calibration verification satisfies both ATS and Social Security Disability requirements for verification at three flow rates The Cal Check is performed at one flow rate and can be accessed immediately after the power on self test or from the Cal Check menu item 5 on the Main screen When running a Cal Check calibration syringes ranging in size from 1 liter to 8 liters may be used and the Renaissance II will automatically determine the size of the syringe A Cal Check may be desirable in addition to the daily three speed SSD calibration to verify volume accuracy at multiple points during studies involving a large number of maneuvers SSD Calibration Verification The Renaissance Ils SSD calibration verification feature can be used to perform either the ATS recommended daily three speed verification or a verification suitable for Social Security Disability claims submissions In both cases the verifications are performed using a 3 L syringe at three flow rates 3 L sec 1 L sec and 0 5L sec To perform an ATS calibration verification obtain a flow sensor and 3 L calibrated
84. ngle best Pre Med or Post Med effort as BEST determined by the Best Criteria configured in Spirometry Options Summarizes each Pre Med or Post Med maneuver with number of attempts number of acceptable tests number of reproducible tests and interpretation if these options are enabled in Spirometry Options S UMMAR Y C2 Displays test results for the best three Pre Med or Post Med efforts as AT eie determined by the Best Criteria configured in Spirometry Options Displays last calibration check results Displays test results for the most recent maneuver only See System Configuration and Spirometry Options 1 on page 78 for information on configuring the spirometer After selecting the desired view option several soft key options are available ePressing the NEXT soft key scrolls the display of numerical test data Pressing the CURVE soft key will display the flow volume curve s for displayed FVC FVL or FEV6 test data Pressing the VT soft key while the flow volume curves are displayed shows the associated volume time curve ePressing the FV soft key while the volume time curves are displayed shows the flow volume graph ePressing the DATA soft key returns to the numerical test data display Pressing the POST soft key will change the display to the Post medication test results for the view option chosen 37 P 495220 00 Rev D Post Test Procedures Printing Results The Renaissance
85. nnecting the Renaissance II spirometer to any instrument verify proper operation Accessory equipment connected to the data interface must be certified according to IEC Standard 950 for data processing equipment or IEC Standard 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of IEC Standard 601 1 1 and the electromagnetic requirements of IEC Standard 601 1 2 P 495220 00 Rev D 2 Listing of Warnings Cautions and Notes User Warnings Chemicals from a broken LCD display panel are toxic when ingested Use caution when handling a Renaissance II spirometer with a broken display panel Flow Sensor Warnings e Carefully read the flow sensor directions before use including all warnings cautions and instructions e User should visually inspect the FSII sensor for loose particles foreign materials prior to patient use CAUTION Federal law restricts this device to sale by or on the order of a physician Use Environment Cautions Do notuse the Renaissance Il Spirometry System in areas of high humidity dust or in extreme environments Place the Renaissance Il Spirometry System in a secure location where it is unlikely to drop or fall
86. ntil the last key press displays the numeral A pause in pressing the key causes the entry point to move to the next character 4 25 When the desired character is high lighted pause or press the cursor key to move to the next character space When the current field is complete press the ENTER key to move to the next field and repeat the pro cess You must enter the patient s height birth date and gender or no interpretation or predicted values will be displayed Enter the patient s race by pressing the corresponding number on the keypad and then pressing ENTER DONE NEW PATIENT Hame Height Birth Gender Race Adjust Weight Yrs smoked 10 Cigs day 15 Yr quit 2000 01JAN2000 12 00PM 70 01 JAN 2000 FEMALE CAUCASIAN 100 0 150LBS NEXT ABC Figure 18 New Patient Numeric NEW PATIENT 1234567 JANE DOE Hame Height Birth Gender Race Adjust Weight Yrs smoked 10 Cigs day 15 Yr quit 2000 UT1JAN2UUU 12 70 01 JAN 2000 FEMALE CAUCASIAN 100 0 150LBS Figure 19 New Patient Alpha P 495220 00 Rev D Entering New Patient Data If desired apply an adjustment factor to which the predicted value and LLN calculations will be multiplied Table 2 lists the factory default set tings and the range of adjustment See the article Spirometric Reference Values from a Sample of the General U S Population 9 for more inf
87. onfiguration and enabling the Confirm Before Delete option 9 Press the Y ES soft key to delete The selected patient data is deleted If a failure has occurred that does not allow you to access the main screen the memory cannot be deleted SOS The optional DataFlowTM Data Management Software Table 1 optional accessory item 15 on page 9 allows the user to upload patient data to a PC for archival in a database Performing this operation prior to deleting patient data from the Renaissance II Spirometer provides a solution for long term patient data storage See the section Using the Renaissance II with a PC and Dataflow Software on page 77 for more information 41 P 495220 00 Rev D Interpretation of the Results Interpretation of the Results Acceptability and Reproducibility Achieving high quality test results depends upon patient effort and technician coaching The Renaissance II spirometer determines the quality of each patient effort by measuring the acceptability and reproducibility of the maneuver and displaying an Acceptability Message that will help both you and your patient achieve accurate results The Renaissance II determines the acceptability and reproducibility of maneuvers based upon the ATS acceptability and reproducibility criteria U These criteria are used to determine which message from Table 5 is displayed at the end of a maneuver A test is considered acceptable if the Good Test mess
88. or mation on race adjustment Table 2 Race Adjustment Settings Factory D efault Setting Adjustment Range African American 88 1096 110 Asian 10096 Caucasian 10096 Hispanic 10076 Other 100 If a race adjustment setting other than the factory default has been entered the spirometer retains the new setting in memory Ensure the race adjustment setting is correct for each new patient NOTE When Caucasian race is selected adjustment settings other than 10096 are ignored in predicted value and LLN calculations 8 10 Continue entering the patient s weight and smoking history years smoked cigarettes per day and year quit if applicable The allowable weight range is 30 440 Ib 15 200 kg See the section Lung Age Inter pretation on page 47 for information regarding the applicability of smok ing history Press the NEXT soft key to enter comments and physician technician medication and dosage information If you need to change any informa tion on the previous screen press the BACK soft key When all desired information is entered press the DO NE soft key to save the data and return to the M AIN screen P 495220 00 Rev D 26 Pre Med Testing Procedures Pre Med Testing Procedures FVC Forced Vital Capacity Test Procedure Patient fainting or falling due to dizziness may occur as a result of this test Advise the patient to sit or stand comfortably near a chair during
89. or by wiping with a damp cloth CAUTION AN Do not spray liquids on the Renaissance II System Follow the cleaning instructions outlined in this section If the need for a more thorough cleaning arises the spirometer base station and tubing can be wiped down with a solution of 7096 Isopropyl Alcohol or 1096 bleach Use the established procedures at your facility for the use and disposal of these disinfecting agents The pressure tube should be replaced at least once every year or if it becomes discolored or cracked To remove the tube grasp the thumb grip where it connects to the spirometer and pull gently until disconnected The spirometer s bar code reader may be cleaned by wrapping a flow sensor s bar coded tab with an alcohol wipe and sliding it through the bar code reader slot CAUTION Do not use the Renaissance Il Spirometry System in areas of high humidity and dust or in extreme environments Chemicals from a broken LCD display panel are toxic when ingested A Use caution when handling a Renaissance II spirometer with a broken display panel Battery Installation The Renaissance II battery should be replaced at least once per year Refer to the battery label to determine battery age When there is a low battery condition fewer than 20 patient tests can be performed the Renaissance II spirometer beeps every 30 seconds and displays a low battery icon NOTE Before replacing the battery print the current co
90. page 54 for more information Intended Use The intended use of the Renaissance II Spirometry System is as a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient s lungs The Renaissance II spirometer obtains the spirometric data by direct measurement of flow via the FSII sensor and pressure tube The flow is then electronically integrated to obtain volume This testing can be used for the detection assessment and monitoring of certain lung diseases The system is intended for use with pediatric 4 to 17 years and adult patients 18 to 99 in hospitals physicians offices laboratories and occupational health testing environments P 495220 00 Rev D 8 Introduction to the Renaissance Il Spirometry System Basic Spirometry B t t System and Accessories a E The Renaissance II Spirometry System is available in a variety of configurations The basic spirometry system consists of the spirometer base station pressure tube AC adapter FSII flow sensors syringe adapter battery pack nose clips and associated documentation See Table 1 Upon receipt of your system verify that all required parts are present and undamaged If any parts are missing or damaged please contact Puritan Bennett Technical Support Department at 1 800 255 6774 Figure 2 Renaissance Il Spirometry System Table 1 Basic Spirometry System and Accessories
91. plunger in over a period of approxi mately 3 seconds for the 1 L sec verification Press the YES soft key to proceed with the 0 5L sec verification P 495220 00 Rev D Pre Test Procedures SSD CAL SWIPE SENSOR OR ENTER CODE Sensor Code ze Temperature 72F Baro Pressure 760mmHg DS DONE CANCEL SSS 01JAH2000 12 00PM Figure 11 Swipe the sensor 10 Follow the directions on the screen and push the 3 Liter syringe plunger in over a period of approximately 6 seconds for the last SSD verifica tion 11 The final SSD CAL screen Figure 13 will display the volume of the calibration syringe the corrected measured volume and associated percentage error for each of the three flow rates indicated on the illustra tion Press DONE to save the calibration results DISCARD to delete or PRINT to print out a record of the results See Printing Results on page 38 for more information on printing 12 NOTE When performing either the CAL check or SSD CAL maneuver if the measured flow or volume is not within allowable range the screen will indicate Unsuccessful CAL Try Again Refer to the Calibration Error section of the Troubleshooting Guide on page 52 to resolve the problem P 495220 00 Rev D SSD CAL 01JAN2000 12 00PM JANE DOE F 40yrs 65 00 FASTER 0 5 L S CAL Flow gt Target Range D Time CANCEL Figure 12 SSD CAL SSD CAL 01JAN2000 12 00PM
92. r operation Accessory equipment connected to the data interface must be certified according to IEC Standard 950 for data processing equipment or IEC Standard 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of IEC Standard 601 1 1 and the electromagnetic compatibility requirements of IEC Standard 601 1 2 P 495220 00 Rev D 54 Troubleshooting Guide During interference the spirometer may not seem to operate correctly Measurements may seem inappropriate or there may be erratic readings cessation of operation or other incorrect functioning If erratic performance occurs survey the location of the Renaissance II system to determine the source of the disruption and take appropriate action as listed below Turn other equipment in the vicinity off and on to isolate the problem e Reorient or relocate the offending device Increase the separation between the interfering equipment and the spirometer If assistance is required contact Puritan Bennett s Technical Support Department or your local Puritan Bennett representative CAUTION The Renaissance II system may be susceptible to radio frequency interference Warranty Information
93. r registers flow when no test is being performed 1 Disconnect pressure tube and re initiate a test procedure If the unit does not auto sense replace the pressure tube 2 Ifthe unit auto senses with nothing connected to it contact Puritan Ben nett Technical Support NOTE Replace the pressure tube every year P 495220 00 Rev D 52 Troubleshooting Guide Patient test values displayed by the Renaissance II do not meet values expected by the physician If the values are unusually high 1 Check for damage to the flow sensor 2 Verify that the flow sensor is not contaminated with sputum or secretions 3 Verify that the patient data height birth date gender ethnic origin being used for the test is accurate for the patient 4 Iftest is FVL verify that proper room temperature and elevation or baro metric pressure have been entered See Table 14 on page 87 in this User s Manual NOTES e Overestimation of the room temperature will cause lung volume to be underestimated by 596 conversely if temperature is underestimated lung volume will be overestimated e Verify that the displayed barometric pressure is correct If not correct there will be an error in the inspired volume FIVC during an FVL maneuver of approximately 1 3 for every 1 000 feet above sea level Refer to the System Configuration section starting on page 78 for more information The barometric pressure displayed is based on the initial elevat
94. r up on AC or battery power 1 Verify wall outlet or power strip is on and functioning properly If not try another outlet 2 Verify power LEDs on spirometer and AC adapter illuminate 3 Contact Puritan Bennett Technical Support if results are unsuccessful Unit powers up but will not perform a test 1 Ifthe spirometer failed the self test record the error message cycle power and try again 2 Ifdisplay does not illuminate press several keys and note if unit beeps in response to key presses 3 Ifthe unit responds to key presses the display contrast may have been adjusted incorrectly From the M AIN screen adjust contrast darker by pressing and holding the DARKER soft key 3rd key from left until the display appears 4 Contact Puritan Bennett Technical Support if results are unsuccessful Error Reading Sensor is displayed in the message window 1 Barcode strip is damaged or sensor swiped incorrectly Swipe the sensor again or manually enter the six digit sensor calibration code 2 Repeat the procedure with a new sensor 3 Clean the spirometer s bar code reader by wrapping a flow sensor s bar coded tab with an alcohol wipe and sliding it through the bar code reader slot 4 Contact Puritan Bennett Technical Support if results are unsuccessful 51 P 495220 00 Rev D Troubleshooting Guide Calibration error is more than 3 1 Verify that the correct temperature is entered 2 Verify that the correct baro
95. ration check will display as part of the spirometer s initialization sequence if a calibration check has not been performed in the current calendar day The American Thoracic Society ATS recommends performing a three speed calibration check on a daily basis e Puritan Bennett recommends that the 3 liter calibration syringe be recertified on an annual basis Verify that the temperature of the room is the same as the temperature noted for the calibration test For every degree discrepancy there will be a corresponding 0 15 error in the test results e Overestimation of the room temperature will cause lung volume to be underestimated by 5 conversely if temperature is underestimated lung volume will be overestimated Test Method Notes The Val best value method is recommended by the American Thoracic Society and mandated by NIOSH OSHA standards and should be used for all industrial and disability testing If the patient test will be submitted for Social Security Disability SSD determinations enter patient information prior to performing the SSD calibration verification Clinicians performing PFT studies should consider attending NIOSH training seminars and refresher courses to further their skills in spirometry testing and to stay current with industry standards Spirometer Use Notes e Demonstrating the test using your FSII sensor is strongly recommended for patients that have never performed a spirometry test before
96. re 72F screen will appear on the display Baro Pressure t66mmHg 3 Press the Y ES soft key to perform the calibration check or NO to proceed with a test When prompted swipe the sensor or enter the numeric code printed on the sensor Figure 14 Figure 14 Enter code or swipe sensor NOTE You may also perform a Cal Check by pressing 5 on the keypad at the MAIN screen or scrolling to CAL CHECK with the cursor key and pressing ENTER 21 P 495220 00 Rev D Continue to follow the screen s directions when prompted Figure 15 When the display prompts push the plunger in smoothly and com pletely over approximately one to two seconds Press the DONE soft key if com plete or pull the plunger out to complete an INSPIRATORY CAL check Figure 16 If the calibration check was suc cessful the syringe volume measured volume and error per centage will be displayed on the final screen Figure 17 To assure accurate patient testing the calibration check volume error is required to be 3 or less If the error is greater than 3 refer to the Calibration Error section of the Troubleshooting Guide on page 52 of this User s Manual Press DONE to save the Cal Check DISCARD to delete or PRINT to print out a record of the Cal Check results See Printing Results on page 38 for more information on print ing Pre Test Procedures CAL CHECK 01JAH2000 12 00PM ATTACH SENSOR TO SYRINGE PULL PLUNGE
97. rmal Equations and References Patients measured values are compared to their predicted values as one way of judging the degree of abnormality of their lung function See references 1 10 16 on page 91 of this User s Manual for tbe journal articles that describe the studies on which these equations are based e Predicted values will be extrapolated for patients with age or A height outside the age and or height limits supported by the selected author s normal equations Results from spirometry testing should not be the sole source for determining a patient s diagnosis and treatment Other clinical data such as patient symptoms and respiratory history should always be considered NOTES e The patient s height birth date and gender must be entered or no interpretation will be displayed e Physiological variant is interpreted as Undetermined in the Renaissance II if FVC and FEV1 are greater than 100 and FEV1 is less than 100 Equation Variables Hi Height in inches Hc Height in centimeters Age in years LLN lower limit of normal P 495220 00 Rev D 60 Technical References Morris MALE Limits age 18 90 years height 58 80 inches FVC FVC LLN FEV1 FEV1 LLN FEV1 FEV1 LLN FEV3 4 241 0 025A 0 148Hi FVC 1 645 0 74 1 260 0 032A 0 092Hi FEVI 1 645 0 55 107 12 0 2422A 0 3118Hi FEV1 1 645 7 79 FVC 95 FEF25 75 2 513 0 045A 0 047Hi FIVC 4
98. rns to the PRE M ED TEST screen Repeat the test up to 8 times if necessary 29 P 495220 00 Rev D Pre Med Testing Procedures FVL Flow Volume Loop Test Procedure WARNING Patient fainting or falling due to dizziness may occur as a result of this test Advise the patient to sit or stand comfortably near a chair during test 1 From the M AIN screen press 2 on the keypad or scroll to TEST using the cursor key and press ENTER 2 From the PRE MED TEST screen press 4 on the keypad or use the cur sor key to scroll to FVL and press ENTER 3 When prompted swipe the sensor or type the numeric code and press ENTER 4 Enter the room temperature and barometric pressure if necessary and press the DONE soft key The sensor will zero and the spirometer will dis play the FVL T EST screen and START TEST prompt NOTES e Verify that the temperature of the room is the same as the temperature noted for the calibration test For every degree discrepancy there will be a corresponding 0 1596 error in the test results e Verify that the displayed barometric pressure is correct If not correct there will be an error in the inspired volume FIVC of approximately 1 3 for every 1 000 feet above sea level Refer to the System Configuration section starting on page 78 for more information The barometric pressure displayed is based on the initial elevation setting of the spirometer However the barometric pressure may
99. s Units When non metric units are selected the patient s height is reported in inches in the patient s weight is reported in pounds lbs the elevation is reported in feet ft and the ambient temperature is reported in degrees Fahrenheit F When metric is selected the units used are centimeters cm kilograms kg meters m and degrees Celsius C PEF Units This configuration determines which units will be used when displaying peak expiratory flow The options are liters second L S and liters minute L M Clock This setting determines how the time is entered and reported The time format options are twelve hour a m p m or twenty four hour Audio If this option is enabled an audible beep will sound when any key is pressed Audio Incentive This setting allows you to activate or suppress the audio incentive that is heard during the patient s effort The audio incentive feature can help the patient and technician achieve better test results O ffset Curves This setting allows you to choose how curves will be positioned on the grid If you disable the offset curves option all of the curves will be superimposed on one another and will begin at the zero point of the grid If you enable the offset option all of the curves will be offset from one another The flow volume curves will be offset by one liter and the volume time curves will be offset by one second This selection will affect the graph sizes Pre post
100. s are used for printer interfacing via standard IEEE 1284 printer cable Table 11 Pin Function Descriptions 1 To Printer Data Strobe 2 To Printer Printer Data Bit 0 3 To Printer Printer Data Bit 1 4 To Printer Printer Data Bit 2 5 To Printer Printer Data Bit 3 6 To Printer Printer Data Bit 4 7 To Printer Printer Data Bit 5 8 To Printer Printer Data Bit 6 9 To Printer Printer Data Bit 7 10 To Base Printer ACK 11 To Base Printer Busy 12 To Base RS232 Clear To Send 13 To Base RS232 Receive Data P 495220 00 Rev D 76 Technical References Table 11 Pin Function Descriptions cont 14 To PC RS232 Request To Send 15 To Base Printer Error 16 To PC RS 232 Transmit Data 17 To Printer Printer Select 18 19 Ground 20 Ground 21 Ground 22 Ground 23 24 25 Ground In order for the computer system to communicate successfully with the Renaissance II Spirometry System an application program must first be written on the computer system This program must do more than act as a terminal because the Renaissance II system requires responses from the computer for setting up the proper handshaking Using the Renaissance II with a PC and Dataflow Software Patient data can be stored and managed on a PC that has optional DataFlow Data Management Software installed DataFlow software enables data transfer to an
101. such a way that a tight seal is formed Coach the patient enthusiastically Take a good deep breath Pull pull itall in Now breathe out and in deeply and quickly Keep going that s good Keep going G ood job 5 The spirometer will display an incentive message and the elapsed time of the test while the real time curve is drawn To display an incentive bar graph instead of the real time curve press the IN CENT soft key when the START TEST prompt appears 6 Upon completion of the test maneu MYY TEST 01JAH2000 12 00PM ver the spirometer will display the 2HE POE FEMALE 49 3RS 65 PRED PRED volume time curve measured pre UYE 1294 1350 9 dicted and of predicted values Fate BPN 52 and number of maneuvers per FRS formed Figure 24 7 Press the SAVE soft key if the maneuver is acceptable Press the DISCARD soft key if the maneuver is unacceptable The display returns SAVE DISCARD to the PRE MED TEST screen Figure 24 MVV Test Complete Repeat the test if necessary Volume 1 P 495220 00 Rev D 32 Pre Med Testing Procedures FEV6 Forced Expiratory Volume in 6 sec Test Procedure Patient fainting or falling due to dizziness may occur as a result of this A test Advise the patient to sit or stand comfortably near a chair during test 1 From the M AIN screen press 2 on the keypad or scroll to TEST using the cursor key and press ENTER 2 From the
102. t be used in conjunction with the interpretations especially when maneuver quality grades are low D or F in Table 6 or Table 7 A flow chart of the interpretation algorithm results is shown in Table 8 NOTE The patient s height birth date and gender must be entered or no interpretation will be displayed 45 P 495220 00 Rev D Interpretation of the Results Table 8 Interpretation Results pan LLN Lower Limit of Normal range Check Maneuver Quality FEV1 below LLN 70 go to Restriction below yes id gt 100 of predicted X8 gt may be a physiological variant no FEV1 gt 70 of predicted mild obstruction no FEV1 above 60 of predicted gt moderate obstruction jd above 50 of predicted 8 gt moderately severe obstruction no FEVT above 34 of predicted ME e severe obstruction no very severe obstruction FVC below LLN and low vital capacity cannot rule Restriction out superimposed restriction FVC below LLN 429 normal spirometry yes FVC above 70 of predicted 2 S ___ mild restriction no FVC above 60 of predicted X68 moderate restriction no FVC above 50 of predicted moderately severe restriction no FVC above 34 of predicted EE EE severe restriction no yes very severe restriction P
103. t off and not power up until the batteries are recharged changed or the AC adapter is connected NOTE If the battery is removed the unit will operate solely on AC power if connected to an electrical outlet via the AC adapter VAN CAUTION The NiCad battery pack or other batteries may discharge over time At least once per month check batteries for corrosion and verify batteries are fully charged Store spirometer in base station to keep unit ready for use Remove batteries if spirometer will not be used for at least two weeks NOTE Puritan Bennett recommends replacing the NiCad battery pack at least once per year Connecting the Pressure Tube The Renaissance II spirometer is shipped with a pressure tube that connects the FSII flow sensor to the spirometer Upon receipt inspect the pressure tube for damage If the tube is damaged contact Puritan Bennett Technical Support at 1 800 255 6774 Connect the pressure tube to the underside of the spirometer as shown in Figure 3 T ube Connect the other end of the pressure tube to the FSII flow sensor as shown in Figure 4 Figure 4 Connecting the Pressure tube to the FS II flow sensor 11 P 495220 00 Rev D Introduction to the Renaissance Il Spirometry System After the batteries have been installed and charged and the tube is connected the spirometer is ready for use The pressure tube does not need to be disconnected from the spirometer between
104. ter key is used to select an option or Enter action in the graphic display Press the up down left or right arrow key to move the cursor D Cursor Keys The four soft keys are used to select the functions displayed on the screen immediately above each key e we Soft Keys MA IN 01JAN2000 12 00PM JANE DOE FEMALE 40YRS 5 32 TEST VIEW cx5 S6 CAL CHECK PRIHT mn O O Keys Cursor Arrow Keys Figure 5 Keypad and Main Screen Green Power Indicator Light P 495220 00 Rev D Initial Configuration Version 1 0 0 301JAH2000 12 00PM INITIAL SETUP 01JAH2000 12 00PM Puritan Bennert Renaissance I Spirometry System Spirometer Ready For Use PROCEED Figure 6 Ready for Use Initial Configuration Date Time Elevation Printer lan 2000 12 00 PM OFT HP COLOR Figure 7 Initial Setup The Renaissance II spirometer has a number of user selectable configuration options which have been preset at the factory The first time the spirometer is powered on after leaving the factory the user is prompted to select the configuration options Refer to System Configuration on page 78 for a complete listing and description of the system configuration settings The Renaissance II Spirometry System is not intended for use in an A oxygen enriched atmosphere or in the presence of flammable anesthetics 1 Pr
105. the spirometer s configuration See System Configuration on page 78 and Print Options 3 on page 80 for information on configuring the printer 4 Check the cable connections When connecting the cable to the base station verify that the thumbscrews have been tightened equally to pro vide a flush connection with the base station connector 5 Verify that the spirometer was docked in the base station for the duration of printing 6 Turn off the printer and remove the spirometer from the base station Turn on the spirometer and place it in the base station Turn the printer on Attempt to print the test results 7 Contact Puritan Bennett Technical Support if results are unsuccessful Electromagnetic Interference The Renaissance II spirometer has been designed to provide reasonable protection against harmful interference in a typical medical environment Because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare environments however it is possible that high levels of interference in close proximity may occur which could disrupt the performance of this device The following is a list of possible types of radio frequency transmitting equipment and other sources of electrical noise sometimes present in healthcare environments e Flectrosurgical units e Cellular phones e Mobile two way radios When connecting the Renaissance II spirometer to any instrument verify A prope
106. tive pattern In addition to the FVC test the Renaissance II spirometer can perform Flow Volume Loop FVL Slow Vital Capacity SVC Maximal Voluntary Ventilation MVV and FEV6 tests These additional tests will sometimes provide more information that is helpful in the diagnosis of a patient s lung disorder 15 P 495220 00 Rev D Spirometry Testing Obtaining Good Test Results Unlike many other medical tests in which the patient is passive spirometry requires active cooperation and strenuous effort by the patient Obtaining the subject s full understanding and cooperation is essential The 10 steps to good spirometry results are listed below e Patient should refrain from taking bronchodilators 6 8 hours prior to testing unless instructed by a physician e Loosen any restrictive clothing Remove loose dentures candy gum etc e Ensure accurate input of ID height weight gender birth date and race e Patient may sit or stand but be consistent and record position Patient fainting or falling due to dizziness may occur as a result of this A test Advise the patient to sit or stand comfortably near a chair during test e The use of nose clips is optional but recommended e Explain procedure carefully and demonstrate how it is done e Coaching is critical Remind patient to BLAST out the air don t just blow Keep going as long as hard and as completely as possible at least 6 seconds e Watch the pat
107. trated by means of graphs showing flow rates and volumes during expiration and inspiration Two types of graphs are used Flow Volume FV and Volume Time VT A typical Flow Volume graph is shown in Figure 30 The Flow Volume graph allows the user to easily evaluate whether the maneuver was poor due to a cough slow start poor effort or early termination In addition obstructive or restrictive disorders can often be detected by examining the waveform Additional guidance can be obtained on this subject in the Introduction to Spirometry Testing section of this manual starting on page 15 The Volume Time Graph shown in Figure 31 is the traditional representation of the data The advantage of this representation is that the FEV1 value as well as most other timed parameters can be read directly from the plot Either graph type can be viewed on the graphical display In addition the spirometer can be configured to print either both or none of the graphs P 495220 00 Rev D Interpretation of the Results PEF Hu e Points o Expiration Figure 30 Flow Volume Graph Total Exhalation Time Figure 31 Volume Time Graph 48 Service and Maintenance Service and Maintenance Cleaning Because the Renaissance II Spirometry System uses disposable single patient use FSII flow sensors there is no need to clean or sterilize any part of the spirometer or pressure tube Remove dust or fingerprints from the exteri
108. ts Parameters Measured FVC FEV1 FEV3 FEV6 FEV1 FVC FEV1 FEF25 75 FEF25 FEF50 FEF75 PEF FET VC FVC Variability FEV1 Variability PEF Variability FIVC PIE FEF50 FIF50 MVV Time MVV Rate FVL SVC Memory Capacity Stores up to 1 000 patient tests Adult Predicted Normal Values Knudson 1983 Knudson 1976 Crapo Morris NHANES III Pediatric Predicted Normal Values Hsu Polgar Dockery NHANES III Interpretation Criteria American Thoracic Society 1991 Lung Function Testing Selection of Reference Values and Interpretative Strategies Am Rev Respir Dis 144 1202 1218 NHLEP Contact Puritan Bennett Technical Support at 1 800 255 6774 for information regarding validation testing 57 P 495220 00 Rev D Technical References Table 9 Product Specifications Renaissance Il Spirometer cont Battery Adapter charger Operating Temperature Operating Humidity 6V rechargeable 600mAh min capacity NiCad battery pack also supports 4 AA Alkaline batteries or NiCad batteries Charge life 10 12 hrs with unit turned ON approx 8 days with unit turned OFF NOTE Do not mix brands or types of batteries Only the custom battery pack can be recharged using the AC adapter Output 12VDC 400mA Adapter Input 120VAC 60 Hz 82mA 9 85VA IEC 601 1 Medical Grade compliant 17 to 40 C 15 to 95 non condensing Operating Altitude Up to
109. ube every year TheLCD panel will turn off after 5 minutes and the unit will power off after 30 minutes with no user input To bring back the display before the 30 minute limit press any key P 495220 00 Rev D 6 Indicators Symbols and Icons Indicators Symbols and Icons Renaissance II Spirometer AN Attention consult accompanying documents IPX1 Refers to degree of protection Drip Proof Type BF equipment Agency Certification O Class II equipment CAUTION Federal Law US restricts Rx ONLY this device to sale by or on the order of a physician SN Serial Number Base Station Connection for a printer port I O communications port T12V 12 volt DC adapter connection FSII Sensor Attention consult accompanying documents Do not reuse single patient use only BoOBp Direction of flow through the flow sensor CAL 233444 Bar coded calibration number ey Recyclable plastic The number 6 represents polystyrene Figure 1 Renaissance Il Spirometry System Indicators Symbols and Icons The Renaissance Il Spirometry System is not intended for use in an oxygen AN enriched atmosphere or in the presence of flammable anesthetics CAUTION Federal law restricts this device to sale by or on the order of a physician 7 P 495220 00 Rev D Introduction to the Renaissance Il Spirometry System Introduction to the Renaissance Il Spirometry System
110. wo best FVC values The differences between good tests and difference must be less than 200 ml those with high variability and instruct accordingly FEV1 There is a difference of at least 200 ml Observe patient performance for VARIABLE between the two best FEV1 values The differences between good tests and difference must be less than 200 ml those with high variability and instruct accordingly PEF There is a difference of at least 10 and Observe patient performance for VARIABLE 1 L sec between the last and best PEF differences between good tests and values those with high variability and instruct accordingly FVC FIVC lt 90 FVC Exhalation Instruct the patient to inhale GREATER significantly greater than inhalation completely at the end of the test THAN FIVC FIVC FVC 90 FIVC Inhalation significantly Instruct the patient to blow out more GREATER greater than exhalation completely THAN FVC GOOD TEST No problems detected N A 43 P 495220 00 Rev D Interpretation of the Results Grading Criteria Unlike many other medical tests in which the patient is passive spirometry requires active cooperation and strenuous effort by the patient The ability of clinicians to elicit this effort varies widely but can be improved with experience and feedback The Quality Grades which range from A to F are displayed on screen and printed on the Best and Best 3 reports for the FVC FEV1 and FEV6 FEV1 tests
111. xhaled volume These parameters are compared to values derived from Predicted Normal Equations based on the patient s age height gender and race These equations are listed starting on page 60 Depending on the results the healthcare professional will be able to determine whether the patient is normal or has an obstructive or a restrictive lung pattern Obstructive diseases are characterized by an increased resistance to air flow This resistance makes it more difficult to move air into and out of the lungs rapidly An obstructive pattern is characterized by a reduction in the volume that can be exhaled in the first second of the FVC test FEV1 and by a low FEV1 FVC ratio The most common obstructive diseases are asthma chronic bronchitis and emphysema Asthma constricts the bronchial tubes but can be controlled by drug therapy Bronchitis also constricts the bronchial tubes but may not respond to drug therapy Emphysema is the slow irreversible destruction of the alveoli leading to collapsed airways Restrictive diseases impair the movement of the lungs or the volume of air that can be expelled by the lungs They are characterized by a reduction in the total volume of air that can be exhaled The FEV1 FVC ratio remains normal or increases Gross obesity lung fibrosis neuromuscular diseases or paralysis can cause restrictive diseases Several occupational related diseases such as black lung and cotton dust lung also result in a restric
112. y and Accountability Act of 1996 LLN Lower Limit of Normal The point which is considered to be the lower limit of the normal patient population for a given parameter This point is defined in the various referenced studies M VV Maximal Voluntary Ventilation measured in liters min The volume of air that can be exhaled during twelve seconds of rapid deep breathing The actual volume is extrapolated to one minute NIOSH The National Institute for Occupational Safety and Health A government agency established by the Occupational Safety and Health Act of 1970 NIOSH is part of the Centers for Disease Control and Prevention CDC and is the only federal institute responsible for conducting research and making recommendations for the prevention of work related illnesses and injuries http www cdc gov niosh homepage html O bstructive Disease Obstructive diseases are characterized by reduced air flow rates making it more difficult to move air into and out of the lungs These diseases often result in a lowered FEV1 and FEV1 or FVC1 Three of the most common diseases include asthma chronic bronchitis and emphysema OSHA Occupational Safety and Health Administration government agency that enforces laws and regulations in the workplace in regard to occupational safety and health hazards PEF Peak Expiratory Flow Rate measured in liters sec or liters min Also called FEF max or PEFR PIF Peak Inspiratory Flow Rate

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