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Fukuda Sangyo ST-95 Spiroanalyzer

1. 16 CHAP EER DJ luj a 17 0 12 A SDA E 17 G7 WEI Fedo a E n 18 633 OTHER ABBRE V CATION TUS BD eee edem ob Tet o epus 19 CHAPTER 72 SI TIN GS 20 TO OR A D C 20 S OPERATION PTT TTTTRTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTT 21 MIO ERN NR NOR REM MC 21 SPON 0 0 1011 22 21 o oa i t un daneado 21 8 5 LOADING HER VEA eua tae eee 22 54 ENTRTOFPATIENES INFORMATION wee akm cede ti iris tud ect seite i oo e kav ices 22 8 5 CORRECTION OF PATIENT INFORMATION ENTRY 23 8 6 CANCELLING OF PATIENT S INFORMATION ENTRY 2 4 000 000000000000 24 SERA VC MEASUREMENT 2 5212 24 SO MEASUREMENT 25 so MVNV MBEASURENIEN rk ko 26 POS TEBRONCG HO DIMA 5 27 Sl L BRONCHIAL
2. 25 1 5 25 70 2 605 0 026 1 336 0 721 0 54 0 78 6 F 25 70 1 050 0 025 1 107 0 512 0 58 0 69 6 MVV 1 5 5 17 1 276 99 507 Polger M 18 1 34xH 1 26xA 21 4 Kory F 5 17 1 276xH 99 507 Polger 18 0 807xH 0 57x A 5 5 Lindall FRC 1 M 7 7 0 58 27 1 2 4 5 25 70 2 348 0 009 1 093 0 443 0 51 0 60 6 7 17 0 56xH27 1 2 4 5 F 25 70 2 245xH 0 001xA 1 003 0 285 0 59 0 50 6 Continued Page 56 of 66 Version 1 2 Parameter Sex RV 1 M M F F TLC 1 M M F F RV TLC M F BSA m Symbol Definition A Age H Height H MVV Height W Weight Age 7 17 25 70 7 17 25 70 7 17 25 70 7 17 25 70 25 70 25 70 all Unit years m cm kg Predicted Equation 0 25 27 1 310 0 022 41 232 0 24xH 7 1 812xH 0 016x A 2 003 1 23 2 7 7 992 7 081 1 17xH2 7 6 602xH 5 791 0 387xA 13 96 0 335xA 18 96 W0 425xH0 725x71 84x10 4 RSDm 0 308 0 196 0 480 0 221 3 87 3 62 Predicted values between 18 and 24 years are calculated as 25 years except MVV Reference 1 A 6 PREDICTED EQUATIONS R 0 73 0 77 0 87 0 94 0 80 0 80 Cotes J E Lung Function 39 Edition Blackwell Oxford 1975 George Polgar M D and Varuni Promadhat M D Pulmonary Function Testing in Children W B Sauders Co Philadelphia 1971 RSD2 0 41 0 35 0 70 0 60 5 46 5 83 Remarks
3. Page 50 of 66 Version 1 2 PREDICTED EQUATIONS 11 2 Knudson Parameter Sex Age Predicted Equation 95 CI Reference VC l all Pred VC Pred FVC FVC 1 6 11 0 0409 43 3756 96 413 K2 12 24 0 0590 0 0739 6 8865 98 100 K2 25 0 0844 0 0298 8 7818 94 653 K2 6 10 0 0430xH 3 7486 95 539 K2 F 11 19 0 0416xH 0 0699x A 4 4470 96 885 K2 20 69 0 0444 0 0169 3 1947 96 493 K2 70 0 0313 0 0296 0 1889 96 614 K2 FEV 5 1 6 24 0 030 0 043 3 054 K1 M 25 0 037 0 017 2 746 K1 6 19 0 019 0 061 41 738 K1 20 0 019xH 0 014x A 0 406 K1 FEV1 1 6 11 0 0348 2 8142 96 997 2 12 24 0 0519 0 0636 6 1181 97 970 K2 25 0 0665 0 0292 6 5147 95 551 K2 6 10 0 0336xH 2 7578 96 300 K2 F 11 19 0 0351 0 0694 3 7622 97 073 K2 20 69 0 0332 0 0190 1 8210 96 944 K2 70 0 0143 0 0397 2 6539 97 048 K2 FEV3 1 M 6 4 0 052xH 0 066xA 5 531 K1 M 25 0 063 0 031 5 245 K1 F 6 19 0 033 0 086 3 417 K1 20 0 035 0 023 1 633 K1 FEV1 G 6 24 0 0813 100 4389 99 035 K2 M 25 0 1050xA 86 6862 98 348 K2 F 6 19 0 1909 0 6655 109 9739 98 687 K2 20 0 1852xH 0 1896x A 121 6777 98 742 K2 1 6 M 6 11 0 0338xH 2 3197 94 410 K2 M 12 24 0 0539xH 0 0749x A 6 1990 95 975 K2 M 25 0 0579xH 0 0363x A 4 5175 92 804 K2 6 10 0 0220 0 8119 92 630 K2 11 19 0
4. ee eee eee ee Respiration Rate Resp min Tidalvotume Parameters bracketed by can be switched according to the utility setting Parameters marked by V are printed on the standard print format Page 17 of 66 Version 1 2 6 2 LCD SCREEN 1 ID screen Jun 12 95 22 X 1234567890 DU VES eld di WHITE 2 Comparison data screen 3 4 DISPLAY Auto calendar Temperature 0 to 50 C ID number maximum 10 digits Age 1 to 99 years Height 90 to 220cm Weight 10 to 220Kg Sex MALE or FEMALE Race WHITE BLACK or OTHERS Measurement Measurement number and Data Best data Second data Last measurement data Predicted value Measurement number Data and Predicted value Measurement number Data and percentage improvement Page 18 of 66 Version 1 2 DISPLAY 6 3 ABBREVIATION USED Abbreviation Meaning Percentage Measured Value divided by the Baseline Value Percentage Measured Value divided by Predicted Value BSA Body Surface Area NF Emterkey 000000000 pi Expiration 0000000 Identification Identification number is mas p 2 Parameter Yers 000000000000 Page 19 of 66 Version 1 2 SETTINGS Chapter 7 SETTINGS 71 CONFIGURATION Prediction equations and interpretation algorithms are user selectable and set as follows Item Description Predicted Equation ITS
5. 5 17 18 5 17 5 17 6 24 25 6 19 20 6 11 12 24 25 6 10 11 19 20 69 70 6 11 12 24 25 6 10 11 19 20 69 70 Predicted Equation Pred VC Pred FVC 4 4 103 67 1000 0 058xH 0 025x A 4 241 3 3x103xH272 1000 0 045 0 024 2 852 0 030 0 043 3 054 0 037 0 017 2 746 0 019 0 061 1 738 0 019 0 014 4 406 2 1 10 3 80 1000 0 036xH 0 032x A 1 260 2 1 103 80 1000 0 035xH 0 025x A 1 932 0 123xH 0 2422x 107 12 0 027xH 0 1815x A 88 70 0 043xH 0 047x A 2 010 0 057xH 0 036x A 2 532 2 621 xH 207 70 60 0 019 0 045 2 513 2621 207 70 60 0 024 0 030 0 551 5 2428 lt 425 5714 60 5 2428 lt 425 5714 60 0 070 0 147 7 054 0 088 0 035 5 618 0 044xH 0 144x A 3 365 0 043xH 0 025xA 0 132 0 0378 2 5454 0 0543 0 1150 6 3851 0 0684 0 0366 5 5409 0 1846xA 0 7362 0 0288xH 0 1111x A 2 3040 0 0321 xH 0 0240x A 0 4371 0 0118 0 0755 6 2402 0 0171xH 1 0149 0 0397xH 0 0057v 4 2421 0 0310xH 0 0230x A 2 4827 0 0109xH 0 1657 0 0243xH 0 2923x A 4 401 0 0075x 0 0174xH 0 0254x A 0 1822 0 0172xA 1 8894 95 CI 94 789 96 052 92 734 93 286 95 109 95 065 95 144 22 905 94 591 90 674 90 705 94 465 91 473 92 742 PREDICTED EQUATIONS Reference qe ce TUS SEBBRBKRBBRKRKRKKIAEAAA K2 Continued Page 54 of 66 Version 1 2
6. PREDICTED EQUATIONS Parameter Sex Age Predicted Equation 95 CI Reference MVV l min M 7 7 1 276xH 99 5 P M 18 1 34xH 1 26xA 21 4 Kory F 7 17 1 276xH 99 5 P F 18 0 807 0 57 5 50 Lindall FRC 1 M 7 17 0 75x103xH292 1000 P M 18 91 0 0472xH 0 0090x A 5 290 1146 F 7 17 1 78x10 3xH2 74 1000 P 18 84 0 0360 0 0031 3 182 1 06 Crapo RV l M 7 17 4 11 103 241 1000 M 15 91 0 0216 0 0207 2 840 0 76 7 17 4 11x10 xH 2 41 1000 P 18 84 0 0197 0 0201 2 421 0 78 TLC 1 747 5 6 103 267 1000 18 91 0 0795 0 0032 7 333 1 61 Crapo F 7 17 4 0 103 73 1000 P 18 84 0 0590xH 4 537 1 08 RV TLC M 15 91 0 3090xA 14 060 8 80 Crapo 17 84 0 4160 14 350 11 0 Crapo BSA m all W0 25x H0725x771 84x 1074 Symbol Definition Unit A Age years H Height cm W Weight kg Reference p George Polgar M D and Varuni Promadhat M D Pulmonary Function Testing In Children Techniques And Standard 1971 M James Morris Arthur Koski and Lavon C Johnson Spirometric Standards for Healthy Nonsmoking Adults AM REV RESPIR DIS 1971 103 57 67 1 Knudson R J et al The Maximal Expiratory Flow Volume Curve Normal Standards Variability and Effects of Age AM REV RESPIR DIS 1976 113 587 600 K2 Knudson J et al Changes in the Normal Maximal Expiratory Flow Volume Curve with Growth and Aging AM REV RESPIR
7. 0 2923 4 401 0 0075 2 94 465 K2 20 69 0 0174 0 0254 0 1822 91 473 K2 F Ur 0 0172xA 1 8894 92 742 K2 MVV l min M 7 18 Pred 1 40 2 19 134 1 26 21 4 56 8 1 Kory 7 18 Pred FEV1x40 2 198 0 807 0 57 5 50 21 0 4 Lindall FRC 1 15 91 0 0472xH 0 0090xA 5 290 146 1 17 84 0 0360xH 0 0031xA 3 182 1 06 1 capo RV 1 15 91 0 0216 0 0207 2 840 0 76 1 Crapo 17 84 0 0197xH 0 0201xA 2 421 0 78 1 crapo TLC 1 15 91 0 0795 0 0032 7 333 1 61 1 Crapo 17 84 0 0590xH 4 537 1 08 1 RV TLC 75 M 15 91 0 3090xA 14 060 8 80 1 17 84 0 4160xA 14 350 11 0 1 Crapo BSA m all W0425xH0 7255x71 84x104 Symbol Definition Unit Range A Age years 7 91 7 84 H Height cm M 7 8 111 190cm M 19 157 194cm F 7 18 111 180 F 19 146 178cm Weight kg Continued Page 49 of 66 Version 1 2 Reference 1 author K1 2 2 PREDICTED EQUATIONS Hsu Crapo Lindall and Kory CLINICAL PULMONARY FUNCTION TESTING 2nd Edition 1984 IntermountainThoracic Society Knudson R J etal The Maximal Expiratory Flow Volume Curve Normal Standards Variability and Effects of Age AM REV RESPIR DIS 1976 113 587 600 Knudson R J et al Changes in the Normal Maximal Expiratory Flow Volume Curve with Growth and Aging AM REV RESPIR DIS 1983 127 725 734 Anonymous Not Published
8. 1 2 4 6 1 2 4 6 1 2 4 6 1 2 4 6 6 6 Sorbini A Casucci G Todisco BULL PHYSIOPATH RESP 11 195P 1975 Zapletal A Motoyama K v d Woestijne K P Hunt R Bouhuys A J APPL PHYSIOL 26 308 1969 Taussig L M Harris T R Lebowitz AM REV RESPIR DIS 116 233 1977 Official Statement of the European Respiratory Society Standardized Lung Function Testing EUR RESPIR J 1983 6 Suppl 16 Page 57 of 66 Version 1 2 PREDICTED EQUATIONS 11 5 SPAIN Parameter Sex Age Predicted Equation SD SEE Remarks SVC 1 3 19 20 70 0 06103xH 0 028xA 4 654 0 56 ECCS 1 F 3 19 FVC 20 70 0 04664 0 024 3 284 0 42 ECCS 1 FVC 1 3 19 0 028 0 03451 0 05728 3 21 20 70 0 0678xH 0 0147xA 6 0548 0 768 0 59 1 3 19 0 03049xH 0 022xW 0 0355xA 3 04 20 70 0 045 0 0211 2 8253 0 608 0 403 1 FEV1 1 3 19 0 02483xH 0 02266xW 0 07148xA 2 91 20 70 0 0499 lt 0 0211 lt 3 837 0 665 0 44 1 3 19 0 02866xH 0 01713xW 0 02955x A 2 87 20 70 0 0317 0 025 1 2324 0 533 0 307 1 FEV3 1 3 19 0 022 0 0469 2 815 0 93 20 90 0 0678 0 0147 6 0548 0 93 3 19 0 022 0 0366 1 924 0 93 20 90 0 0454xH 0 0211xA 2 8253 x0 93 FEV1 T 0 16xA 85 62 0 24x A 91 02 FEV1 G 76 M 20 0 0 1902xA 85 58 5 85 5 36 1 20 70 0 224xA 0 1126xW 494 88 6 29 5 31 1 1 5 M
9. 50 pre test data or 25 pre post test data 1 channel for data transmission This instrument may only be connected to PC meeting EN60950 Standard Page 9 of 66 Version 1 2 3 3 OTHER SPECIFICATION 1 Power supply Voltage Frequency Power input Fuse Operating conditions lemperature Humidity Transport Stocking conditions lemperature Humidity Dimensions Size Weight Casing material PC connection via RS 232C SPECIFICATIONS 100 240 V 50 60Hz 25 VA max T 2Ax2 250V IEC 127 2 10 to 40 C Under 80 no condensation 25 to 70 C Under 95 no condensation 220mm D 230mm 86mm 1 3002 Main Unit 500g Flow Sensor ABS Formaldehyde free This instrument may only be connected to PC devices meeting EN60950 Standard Page 10 of 66 Version 1 2 Chapter 4 PARTS IDENTIFICATION 4 1 MAIN UNIT PARTS IDENTIFICATION SPIROAHALYZER ST 95 5 L BEE Number Description Serial Communication RS 232 Port Liquid Crystal Display Sensor Tube Couplers male Page 11 of 66 Version 1 2 PARTS IDENTIFICATION 4 2 INTERNAL STRUCTURE Description Keyboard Assembly Switching Power Supply Pressure Transducer Main Board ROM Read Only Memory Printer Page 12 of 66 Version 1 2 PARTS IDENTIFICATION 4 3 FLOW SENSOR Number Description Complete Sensor Tube e 4 4 ACCESSORIES Description Printer Paper
10. BSA m Symbol Definition H Height H BSA Height A Age Weight Age 3 19 7 14 254 7 14 25 7 14 25 7 14 251 7 14 25 7 14 25 25 25 7 14 25 7 14 20 25 25 7 14 25 7 14 25 25 258 All Unit m m yrs kg Predicted Equation Pred VC Pred FVC 1 00 27 7 40xH 0 029x A 6 68 0 95xH 7 5 22 0 021 4 10 0 84 H27 5 74 0 034 4 54 0 81 H 7 3 29 0 027 1 22 0 84 0 18 87 21 0 84 0 19xA 89 10 6 08xH 0 044xA 4 73 0 051xA 5 41 8 2xH 6 8 354xH 1 97xA 9 60 6 7xH 5 3 274xH 2 04xA 59 60 5 46 0 029 0 47 3 22 0 025 1 60 5 6 4 4 3 79 0 031 0 35 4 6xH 3 3 2 45xH 0 025xA 1 16 2 61xH 0 026xA 1 34 1 05xH 0 025xA 1 11 W0425x H0 725x 71 84x10 4 1 Equations of the predicted values as ECCS to be applied Predicted values between 15 and 24 years are calculated as 25 years PREDICTED EQUATIONS Remarks 124 12 4 12 4 1 2 4 1 274 ECCS 1 1 2 4 51 15 574 1 3 4 ECCS 1 ECCS 1 1 3 4 ECCS 1 1 3 4 ECCS 1 ECCS 1 ECCS 1 Continued Page 60 of 66 Version 1 2 PREDICTED EQUATIONS Reference 1 Cotes J E Lung Function 39 Edition Blackwell Oxford 1975 25 George Polgar M D and Varuni Promadhat M D Pulmonary Function Testing in Children W B Sauders Co Philadelphia 1971 3 Sorbini C A Casucci G Todisco BULL PHYSIOPATH RESP 11 195P 1975 4 Zapletal A Motoy
11. Oslo Norway me 21 02 Interpretation Algorithm ITS Expression of Expiratory Flow Display and print formats are executed according to the above settings Most recent settings are backed up by battery and kept in the memory until the next setting change Setting operation is described in 8 16 OTHER OPERATIONS ITS prediction equation will be automatically selected by the instrument in cases where ITS or ITS NIOSH OSHA interpretation 15 selected No other prediction equation may be selected with the ITS or ITS NIOSH OSHA interpretation setting Page 20 of 66 Version 1 2 OPERATION Chapter 8 OPERATION 6 1 PREPARATION 1 Insure the correct connection of the flow sensor to the main unit The WHITE and the BLACK tubes of the flow sensor secured to their matching color coded couplers in the main unit and the heater plug snugly connected to the heater jack Should the flow sensor tubes connection to the main unit be reversed inspiration and expiration flow data will be detected and shown in the opposite polarity m case a disposable flow sensor is used connect the flow sensor to the sensor handle insuring correct direction An engraved wart on the side of the handle shows where the patient s mouth should be directed We recommend using a paper mouthpiece 2 Slide the tapered rubber tube wide opening to the flow sensor front end where the rim is marked Then insert the cylindrical paper mouthpiece ins
12. Thermal type NOTE Disposable paper mouthpieces are not included as a standard accessory to this instrument Page 13 of 66 Version 1 2 PARTS IDENTIFICATION 4 5 OPERATIONAL KEYS UTILITY START e FLOW SENSOR HOLDER Description Type in keys for detail information entry ENT Delimiter for key entry confirmation Cancellation of key entry detail ety _ Launch VC measurement and display b ESTE Page 14 of 66 Version 1 2 CAUTIONS Chapter 5 CAUTIONS 5 1 GENERAL CARE 1 Read and understand the instruction manual before operating the instrument 2 Handle the instrument with care especially during transport 3 Do not alter or repair this instrument by yourself 4 user serviceable parts are included in this instrument Repairs must be done authorized FUKUDA SANGYO service personnel only 5 2 INSTALLATION 1 Locate the instrument atop a sturdy and level surface with a minimum 10cm clearing at both sides and rear 2 Locate the instrument in a stable environment where no abrupt temperature humidity or pressure change occurs 3 Locate the instrument in clean surroundings where no ambient dusts salts or ions are found 4 Do not operate the instrument where the ambient temperature is over 40 C or under 10 C 5 Do not immerse the instrument in water 6 Do not expose the instrument to direct sunlight or excessive vibration 5 3 ELECTROMAGNETIC COMPATI
13. 1000 0 05666 0 02403 0 22544 0 03594 0 01776 1 13160 0 03555 0 01987 2 72554 0 02707 0 01926 2 14653 0 02569xH 0 03049x A 2 40337 0 02449 0 02344 1 42640 0 01411xH 0 04142xA 1 98361 0 00919 0 03450 2 21596 108xBSA 60 86 5 0 522xA xBSA 77XBSA 24 713 0 474 5 0 005xA 1 67 xH 100 0 007xA 1 20 xH 100 0 010xA 0 55 xH 100 0 009xA 0 42 xH 100 3 40 100 2 51xH 100 0 330xA 0 140xW 23 4 0 280x A 0 270xH 28 0 W0425x H0 725x71 84x10 4 PREDICTED EQUATIONS Reference Ishida Kanagami Kanagami Baldwin Ishida Kanagami Kanagami Baldwin J Bjure Berglund J Bjure Berglund Berglund Berglund Dickman Schmidt Dickman Schmidt Cherniack Cherniack Cherniack Cherniack Cherniack Cherniack Cherniack Cherniack Needham Baldwin Needham Baldwin Nishida Nishida Nishida Nishida Nishida Nishida Grimby Grimby Continued Page 64 of 66 Version 1 2 PREDICTED EQUATIONS Symbol Definition Unit A Age years Height cm Weight ke Page 65 of 66 Version 1 2 ERROR MESSAGES Chapter 12 ERROR MESSAGES When any trouble occurs an error message is displayed ERROR MESSAGE TROUBLE SOLUTION BACK UP RAM NG The memory device of the Turn off then turn on the power instrument may be defective switch to reset If the same message is displayed contact your Fukuda Sangyo dealer Extrapolated Volume NG Vext Value exceeds the standard Depre
14. 3 19 0 088xH 0 14x A 4 33 M 20 70 0 0392xH 0 043xA 1 16 1 24 1 1 3 19 0 046xH 0 051xA 4 3 20 70 0 023 0 0456 1 1055 0 96 0 68 1 PEF 1 5 3 19 0 075xH 0 275xA 9 08 20 70 0 0945 0 0209 5 7732 1 67 1 47 1 F 3 19 0 73 0 134 7 57 20 70 0 0448 0 0304 0 3496 1 18 1 04 1 25 1 5 3 90 0 031xA 2 88xB 3 38 3 90 0 024x A 0 105xH 0 3 50 1 5 3 19 0 017 0 157 0 029 2 17 M 20 70 0 0517 0 0209 2 4 1 47 1 3 1 3 19 0 046xH 0 067xA 4 17 20 0 0 0242 0 0418 1 6151 1 11 0 925 1 FEF75 1 8 3 19 0 024 0 066 2 61 20 90 0 0190 0 0356 0 1405 3 19 0 027 0 032 2 68 20 90 0 02 0 031 0 0062 0 212 PIF 1 5 20 90 0 023xA 0 006xW 1 19x B 3 87 20 90 0 014xA71 15xB42 73 Continued Page 58 of 66 Version 1 2 Parameter Sex Age MVV 1 3 90 E 23519 20 90 FRC 1 M 7 17 25 70 7 17 25 70 1 7 17 25 70 7 17 25 70 TLC M 7 17 25 70 7 17 25 70 RV TLC 25 70 25 70 BSA m all Symbol Definition Unit A Age years B BSA m H Height cm H ECCS Height m W Weight kg Predicted Equation 1 276xH 99 5 1 276xH 99 5 0 807xH 0 57x A 5 5 0 58xH 7 2 348 0 009 41 093 0 56xH 7 2 245 0 001 41 003 0 25 27 1 310 0 022 1 232 0 24 27 1 812 0 016 2 003 1 23xH2 7 7 992 7 081 117 2
15. OPERATION i 1 SELECT Select option 1 SELECT from the DELETE 1 menu to display the ID numbers of data stored 0002 0000000003 in the memory Select the patient ID number P 0000000004 and key in the numerical tag number and 5 depress the ENT key Depress the or V arrow 0000006 0000006 keys to scroll through the list of ID numbers in SELECT the memory ii When the patient data to be deleted is selected SELECT a confirmation screen is displayed Depress 1 key and then ENT key to confirm deletion or ID 0000000001 depress 0 key and then the ENT key to cancel deletion Thereafter the screen returns to the ID screen SELECT 4 iii 2 ALL Select option 2 ALL from the DELETE menu to initiate total deletion Confirm action by depressing 1 and then the ENT key to effect total deletion or depress 0 and then the ENT key to cancel deletion action Thereafter the screen returns to the ID screen SELECT 4 d Printing of Saved Measurement Data PRINT Select option 4 PRINT from the MEMORY menu to enables the printing of all saved measurement data The printout format shall depend on the data set type i e Pre data Post data BASE data or DOSE data Auto calibration CALIBRATION Select option 2 CALIBRATION from the UTILITY menu by keying the numerical label 2 and the ENT key to conduct calibration Auto calibration is done with an optional three liter calibration syringe Where it is recom
16. done using a detergent water solution containing a maximum volume percentage of 20 of Cidex Citrosil or the like Push in the rubber tube into the front side of the flow sensor to ready 10 3 LAMINAR FLOW TUBE METAL To remove the laminar tube from the flowhead hold the flowhead rigidly with its front side towards you and grasp the laminar tube with the free hand Rotate the laminar tube about one Page 46 of 66 Version 1 2 CLEANING AND STERILIZING eight clockwise Turning the flowhead on its backside push out the laminar tube until clear of the flowhead Proceed to the cleaning of the bare laminar flow tube using the following methods 1 You may use Ethylene Oxide gas to sterilize the laminar flow tube 2 You may autoclave the laminar flow tube up to 132 C of temperature 2 bar 10 minutes 3 The sterilization procedure for the laminar tube can be done using a detergent water solution containing a maximum volume percentage of 20 of Cidex Citrosil or the like Make sure that the laminar flow tube is completely dry before reusing Remaining water drops even in small amounts may cause measurement errors Shake the laminar flow tube to remove water drops To re install the laminar tube into the flowhead position the laminar tube to the front side of the flowhead with the locking lug of the laminar tube located at your left and near side Push slide the laminar tube until the locking lug firmly sets into th
17. each time a complete key entry has been made Page 22 of 66 Version 1 2 OPERATION Date of measurement Date is automatically provided by the built in calendar IC Room temperature Accepted range is from 0 50 C 32 to 122 F for room temperature The keyed in temperature value will automatically be the basis for BTPS correction If a previous patient was tested the last temperature data is displayed ID number Accepted range is from 0 to 9999999999 maximum of 10 digits The last ID number is incremented by one should a patient data still remains in memory Age Accepted range is from 1 to 99 years old Height Accepted range is from 90 to 220cms 37 to 89ins Weight Accepted range is from 10 to 220kgs 23 to 488lbs Sex Depress A or keys to move the cursor to either the MALE or FEMALE selection Race Press the A or Y keys to move the cursor to either the WHITE BLACK or OTHERS selection 8 5 CORRECTION OF PATIENT INFORMATION ENTRY To make a correction on the patient information ID entry proceed in the following procedure 1 If the erroneous entry is still pop up window where the ENT key has not yet been depressed depress the CLR key to delete the error in the window You may then enter the correct value and depress the ENT key to confirm the correction If the erroneous entry is already displayed in the ID screen after an ENT key has been depressed depress the ENT key repeatedly
18. to the RACE window and the ENT key is depressed the last patient data will already be deleted Inadvertent depressing of the START key Whenever the START key is depressed the measurement screen is displayed To recover depress the CLR key to cancel the measurement and have the data comparison screen restored in the display 8 13 SELECTION AND DISPLAY OF DATA This instrument stores three 3 VC three 3 FVC and two 2 MVV data sets per patient in the memory Each data can be selected and displayed The best and second best data are automatically selected on each measurement under the following conditions Measurement Criteria Best VC data The largest VC value Best FVC data The largest value of FVC FEV1 Best MVV data The largest MVV value Data selection can be manually selected with the numerical keys 1 2 or 3 The selected data will be marked In the event a measurement is conducted more than three time 3X for both the VC and FVC tests and two times 2X for the MVV the data without the marks or O is overwritten in the display and marked with _ by the new measurement Page 32 of 66 Version 1 2 OPERATION 6 14 EXPANDED WAVEFORM SCALE Where an expanded graphical scale is required depress the ENT key to shift the graphical display to double scale 2X during measurement or display Selecting double scale on the display will also cause the waveform to be printed as such To return to normal scale depress t
19. 0 76 17 84 0 0197 0 0201 2 421 0 78 TLC 1 15 91 0 0795 0 0032 7 333 1 61 Crapo 17 84 0 0590xH 4 537 1 08 RV TLC 15 91 0 3090xA 14 060 8 80 17 84 0 4160 14 350 11 0 Crapo BSA m all W0425x H0 725x71 84x104 Symbol Definition Unit A Age years H Height cm Reference 1 Knudson J et al The Maximal Expiratory Flow Volume Curve Normal Standards Variability and Effects of Age AM REV RESPIR DIS 1976 113 587 600 Continued Page 52 of 66 Version 1 2 K2 Comp Crapo Anon PREDICTED EQUATIONS Knudson J et al Changes in the Normal Maximal Expiratory Flow Volume Curve with Growth and Aging AM REV RESPIR DIS 1983 127 725 734 Composite of Kory Cherniack and Armstrong studies Crapo H Morris Lung Volumes in Healthy Nonsmoking Adults BULL EUROP PHYSIOPATHOL RESPIR 1982 18 419 425 Anonymous Not Published Page 53 of 66 Version 1 2 11 3 MORRIS POLGAR Parameter VC FVC l 5 FEV1 0 1 FEV1 G MEER 1 5 1 5 PEF 1 5 FEF25 1 5 FEF50 1 5 75 1 5 kmj Em sao 12 9 8 126 5280 emp 48 EI sa Emi kb cec Deep dispo Age all 5 17 18 5 17 18 6 24 25 6 19 20 5 17 18 5 17 18 18 18 18 18 5 17 18
20. 0279 0 1275 2 8007 95 015 K2 20 69 0 0300 0 0309 0 4057 94 559 K2 70 0 0615xA 6 3706 93 714 K2 PEF 1 5 6 24 0 078 0 166 8 060 K1 M 25 0 094xH 0 035xA 5 993 K1 F 6 19 0 049 0 157 3 916 K1 20 0 049 0 025 0 735 K1 Continued Page 51 of 66 Version 1 2 PREDICTED EQUATIONS Parameter Sex Age Predicted Equation 95 CI Reference 25 1 5 6 24 0 070xH 0 147xA 7 054 K1 M 25 0 088xH 0 035xA 5 618 K1 6 19 0 044xH 0 144x A 3 365 K1 F 20 0 043xH 0 025xA 0 132 K1 FEF50 1 5 M 6 11 0 0378xH 2 5454 94 789 K2 M 12 24 0 0543 0 1150 6 3851 96 052 K2 M 25 0 0684 0 0366 5 5409 92 734 K2 610 0 1846xA 0 7362 93 286 K2 11 19 0 0288 0 1111 2 3040 95 109 K2 20 69 0 0321 0 0240 0 4371 95 065 2 70 0 0118 0 0755 6 2402 95 144 K2 FEF75 1 5 611 0 0171 1 0149 92 505 K2 12 24 0 0397xH 0 0057v A 4 2421 94 591 K2 M 254 0 0310 0 0230 2 4827 90 674 K2 610 0 0109 0 1657 90 705 K2 F 11 410 0 0243 0 2923 4 401 0 0075 2 94 465 K2 20 69 0 0174 0 0254 0 1822 91 473 K2 F 70 0 0172xA 1 8894 92 742 K2 MVV l min M 6 19 Pred FEV1x40 Anon M 20 1 15 1 27 14 619 Pred FEV1x40 Anon 207 0 55 0 72 50 FRC 1 15 91 0 0472 0 0090 5 290 1 46 17 84 0 0360xH 0 0031xA 3 182 1 06 Crapo RV 1 M 15 91 0 0216 0 0207 2 840
21. 112 09 4 6 1 194 0 0937 0 163 118 16 5 4 1 Crapo 1 5 7 18W 7 98 104 246 60 26 1 Hsu M 7188 3 61 104 2 60 60 36 1 Hsu 19 0 0204 0 0380 2 133 1 67 1 7 18W 35 79 105 216 60 28 1 Hsu 7188 1 45X10 xH2 54 60 30 1 Hsu F 19 0 0154 0 0460 2 683 1 36 1 PEF 1 5 7 18W 3 35 104 279 60 18 1 Hsu 7188 1 74x104xH2 92 60 22 Hsu 19 24 0 078 0 166 8 060 K1 M 25 0 094xH 0 035xA 5 993 K1 7 18 2 58 103 237 60 18 1 Hsu 7188 5 51 104 2 68 60 20 1 Hsu F 19 0 049 0 157 3 916 K1 20 0 049 0 025 0 735 K1 Continued Page 48 of 66 Version 1 2 PREDICTED EQUATIONS Parameter Sex Predicted Equation 95 Reference 25 1 5 7 24 0 070 0 147 7 054 K1 M 25 0 088xH 0 035xA 5 618 K1 F 7 19 0 044 0 144 3 365 K1 20 0 043 0 025 0 132 K1 FEF50 1 5 M 7 11 0 0378xH 2 5454 94 789 K2 M 1224 0 0543 0 1150 6 3851 96 052 K2 25 0 0684 0 0366 5 5409 92 734 K2 7 10 0 1846 0 7362 93 286 K2 11 19 0 0288xH 0 1111xA 2 3040 95 109 K2 20 69 0 0321 0 0240 0 4371 95 065 K2 70 0 0118 0 0755 6 2402 95 144 K2 FEF75 1 8 M 7 1 0 0171xH 1 0149 9250 K2 12 64 0 0397 0 0057 4 2421 94 591 K2 M 25 0 0310 0 0230 2 4827 90 674 K2 7 10 0 0109 0 1657 90 705 K2 11 19 0 0243
22. 6 1 643xIn H 0 3481xIn A 1 089xFi 1 561 1 177xIn H 0 0045xA 0 000140x A 2 2 e 1 576 1 166xH 0 0219xA 0 0021xW 1 314 0 898xIn H 0 0083xA 0 000026x A 2 2 e 0 722 2 002xIn H 0 3063xIn A 0 409xFi 1 372 0 938xIn H 0 0152xA 0 000036x A 2 2 1 388 0 77xH xVC 1 1340 0 0053xA xVC 1 388 0 77xH xVC 1 2413 0 0036xA xVC Range lt 17 1 09 1 96 m gt 18 1 44 2 00 lt 15 1 10 1 82 gt 16 1 40 1 90 m M F 5 90 Page 63 of 66 Version 1 2 11 9 JAPAN Parameter VC 0 FEV1 1 FEV1 G 1 5 PEF 1 5 75 1 5 MEF50 1 5 MEF25 1 5 MVV l min FRC 1 RV l TLC 1 RV TLC 96 BSA m2 oem ox 2 2 Eum kr mm Se 20820 6 12 13 14 17 18 6 12 13 14 17 18 7 17 18 7 17 18 18 18 5 17 18 5 17 18 15 15 15 15 15 15 15 15 11 15 16 11 15 16 18 18 18 18 18 18 18 18 all Predicted Equation 34 0 2487 1000 140 1 20 1000 048 17 18 1000 27 63 0 112 1000 34 3 2609 1000 1 70 6 70 1000 A 3 10 xH 1000 21 78 0 101 1000 0 782xH3x10 6 0 011 0 0344 0 033 1 00 0 683xH3x10 6 0 221 0 0267 0 027 0 54 91 79 0 373 92 11 0 261 37 01 2614 1000 20 08xH 46xA 2954 1000 34 25 2389 1000 16 93 37 2243
23. 7 6 602xH 5 791 0 387xA 13 76 0 335xA 18 96 W0425x H0725x71 84x10 4 1 Equations of the predicted values as ECCS to be applied Predicted values between 18 and 24 years are calculated as 25 years Reference PREDICTED EQUATIONS SD SEE Remarks ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS 1 ECCS ECCS 1 ECCS 1 J Roca J Sanchis A Agusti Vidal F Segarra D Nvajas R Rodriguez Roisin P Casan S Sans Spirometric Reference Values from a Mediterranean Population BULL EUROP PHYSIOPATHOL RESPIR 1986 22 217 224 Cotes J E Lung Function 39 Edition Blackwell Oxford 1975 George Polgar M D and Varuni Promadhat M D Pulmonary Function Testing in Children W B Sauders Co Philadelphia 1971 Sorbini C A Casucci G Todisco T BULL PHYSIOPATH RESP 11 195P 1975 Zapletal A Motoyama E K v d Woestijne K P Hunt V R Bouhuys A J APPL PHYSIOL 26 308 1969 Taussig L M Harris T R Lebowitz M D AM REV RESPIR DIS 116 233 1977 Testing EUR RESPIR J 1983 6 Suppl 16 Official Statement of the European Respiratory Society Standardized Lung Function Page 59 of 66 Version 1 2 11 6 05LO NORWAY Parameter Sex VC 1 All FVC 1 M M F F FEV1 1 M M F F FEV1 T M M F F 1 5 1 5 75 1 5 MEF50 1 5 25 1 5
24. BILITY This device has been proven to comply with EN60601 1 2 for Medical Electrical Equipment under the Collateral Standard for Electromagnetic Compatibility Requirement and Tests in the Harmonized Standards In order to further warrant a good level of electromagnetic immunity it is suggested that the instrument be kept away from devices generating electromagnetic fields or interference such as loudspeakers television sets cellular telephones other telephonic apparatus or any similar devices 5 4 FUSES REPLACEMENT To replace the power fuses perform the following procedures Turn the power switch of the Main Unit to OFF Disconnect the instrument from the ac mains On the rear side of the Main Unit unscrew the two fuse holders clockwise using a suitable tool Remove both fuses from their receptacles Page 15 of 66 Version 1 2 CAUTIONS 5 Substitute the blown fuse with a known good fuse of an identical characteristic with that of the replaced fuse 6 Restore the fuses into their receptacles and screw the fuse holder clockwise using a suitable tool 7 Connect the instrument to the ac mains 8 Turn the power switch to ON 5 5 THERMAL PAPER This instrument includes a printer device that uses thermal paper The proper handling of new and unused thermal paper are observe by the following actions 1 Keep away from direct sunlight or placed in a high temperature environment where the paper may discolor at abo
25. C FVC or MVV tests desired and select the best data from the measurements made The selected measurement shall serve as the pre bronchodilator data of the patient If so required the appropriate procedure for report printing or data transfer should be done now b Proceed in the administering of the medication to the patient The post bronchodilator test is typically conducted after a fifteen minute period c Depress the POST key to set the patient pre bronchodilator data into memory afterwhich the patient ID screen is displayed The post bronchodilator test is now ready Page 27 of 66 Version 1 2 4 5 OPERATION Perform the post bronchodilator test using the same VC FVC or MVV test procedure desired The pre bronchodilator and post bronchodilator measurement data as well as the response rate are thereupon displayed Post is indicated on the comparison data screen Enter a new patient ID to exit Post Bronchodilator Testing multiple patients testing Perform on the individual patient the VC FVC or MVV tests desired and select the best data from the measurements made The selected measurement shall serve as the pre bronchodilator data for each individual patient If so required the appropriate procedure for report printing or data transfer should be done now Therewith save the measurement data into memory using the procedures outlined in 8 17 OTHER FUNCTIONS Proceed in the administering of the medication to th
26. CERALLENGE ES LINO Sa a a o 29 8 12 DATA PROTECTION FROM OPERATIONAL 2 2 0 0 00000000000000000000000 32 8 13 29 DEC LION AIND DTS PAs YOR DA A sus Seca 32 B E E XPANDEDAVAV BEORMISCA BEE 33 B lo RECORDFILINGJIN NIBNIOBRBM 33 oko PRINTING 2512 211401 OT ta DAJ due MEUM 34 5 1 01 FONCTIONS i us tei ben nmi slum EL IM CU I I I 34 CHAPTER S SABE KEEPING va eei Eko va Pe Roue 45 SM BE PO WING RR 45 Page 5 of 66 Version 1 2 CONTENTS CHAPTER 10 CLEANING AND STERILIZING 46 10 1 CLEANING THE EXTERNAL THE 46 1 2 TAPERED RUBBER TUBE deut Re be do side dedu dde 46 I0 S LAMINAR PLOW UBE METE lva Pod aae 46 INOSEC LIP CIDE A fatu KONTA DL 47 CHAPTER 11 PREDIC FED EQUATIONS sss ipa ao E KA 48 TES INTERMOUN TAIN THORACIC SOCK VY 48 11 241 0201 TETTE eit oe 51 NORRIS uga e uedo Sao nka SER E 54 11 4 ECCS
27. DING THERMAL PAPER To load a roll of thermal paper jointly press and slide rearward at the area marked PUSH A OPEN of the printer cover The cover may then be lifted and swung open towards the back Take the end of the paper roll curled up and insert its end into the slit located at the bottom of the paper basin Depress the FEED key several times until the paper advances out from the top opening Grab the paper end and thread it through the paper cutter outlet of the printer cover To secure the paper roll in the basin close the printer cover then jointly press and slide forward at the area marked embossed PUSH A OPEN of the printer cover to lock Check that the printer paper has its print face in front when the printer cover is closed Refer to the following picture 8 4 OF PATIENT S INFORMATION With the patient information gathered and the ID screen displayed on the LCD depress ID key to enter DATE 44 28 95 the patient information TEMP AO 10 4 ile h ind fe cent d AGE yrs The TEMP window pops on the display ready to Ht accept a keyed in entry Depress ENT key upon TEMP completion of keyed in entry The ID screen always retains and displays the last measurement data made Only upon complete entry of the new patient information will the last measurement data be deleted Should the previous data be needed save the data before entering the next patient ID number Depress the ENT key
28. DIS 1983 127 725 734 Crapo Crapo and A H Morris Lung Volumes in Healthy Nonsmoking Adults BULL EUROP PHYSIOPATHOL RESPIR 1982 18 419 425 Page 55 of 66 Version 1 2 PREDICTED EQUATIONS 11 4 ECCS European Community for Coal and Steel Parameter Sex Age Predicted Equation RSDm R RSD2 Remarks VC 1 M 7 17 FVC 1 24 25 70 6 103xH 0 028xA 4 654 0 251 0 94 056 6 7 17 1 2 4 25 70 4 664 0 024 3 284 0 270 0 90 042 6 FVC 1 M 7 17 1 00 27 15254 25 70 5 757xH 0 026xA 4 345 0 304 0 92 0 61 6 F 7 17 0 95xH27 1 2 4 25 70 4 426 0 026 2 887 0 234 0 93 0 43 6 FEVI 1 7 17 0 84xH27 12 25 70 4 301xH 0 029xA 2 492 0 258 0 93 0 51 6 F 7 17 0 81 27 1 2 25 70 3 953xH 0 025x A 2 604 0 205 0 94 038 6 FEV1 T 76 M 7 7 0 84 12 4 25 70 0 179 87 21 3 85 0 53 7 17 6 7 17 0 84 1 2 4 25 0 0192 4891 3 73 0 59 6 51 6 1 5 25 70 1 944xH 0 043xA 2 699 0 683 0 66 1 04 6 25 70 1 252 0 034 2 924 0 437 0 73 0 85 6 PEF 1 5 M 7 17 8 2xH 6 8 1 3 4 25 70 6 146xH 0 043xA 0 154 0 787 0 74 1 21 6 7 17 6 7 5 3 13 4 25 70 5501 0 030 1 106 0 707 0 69 0 90 6 MEF75 1 5 25 70 5 459 0 029 0 470 0 534 0 80 1 71 6 25 70 3218 0 025 1 596 0 230 0 90 1 35 6 MEF50 1 5 7 7 5 6xH 4 4 1 3 4 25 70 3 794xH 0 031xA 0 352 0 934 0 54 1 32 6 7 17 4 6 3 3 1 3 4 25 70 2 450xH 0 025xA71 156 0 532 0 53 110 6
29. EUROPEAN COMMUNITY FOR COAL AND 56 IN C 58 m 60 TTET y 62 p E 63 JATA N noti reer ee ee ree te 64 CHAPTER 12 ERROR MESSAGES ava 66 Page 6 of 66 Version 1 2 INTRODUCTION Chapter 2 INTRODUCTION 2 1 OUTLINE The ST 95 SPIROANALYZER belonging to Fukuda Sangyo s family of Spirometer products is a pulmonary function testing instrument intended for performing patho physiological breathing tests to evaluate human respiratory functionality The instrument is used by general physicians respiratory practitioners or qualified personnel in medical hospitals medical centers clinics or near the patient during domiciliary visit The instrument carries out measurements of a patient s pulmonary Vital Capacity VC Forced Vital Capacity FVC and Maximum Voluntary Ventilation MVV by capturing instantaneous air flow data at discreet intervals of time while the patient does a prescribed breathing maneuver The flow data pattern being displayed graphically on a LCD screen display Its capability also extends to the storage and analysis per patient for three 3 series of VC and FVC data respectively and two 2 series of MVV data that maybe displayed in tabulated data form on the same LCD screen The acquired and analyzed data may then be com
30. ONDITION With a nose clip applied at the patient s nostril make the patient breath in and out in deep and rapid rhythmic manner into the flow sensor mouthpiece Depress the START key while urging the patient to keep the voluntary effort on a constant rhythm like one two one two Respiratory waveform should now be seen in the screen 41 MV Page 26 of 66 Version 1 2 OPERATION 4 If the measurement is not satisfactory due to respiratory disorder or improper maneuver depress the START key to re start the measurement from zero time and repeat from procedure 2 To abort measurement depress the CLR key 5 Duration for MVV measurement is 12 seconds the generally recommended test duration To abort measurement depress the STOP key The instrument however requires a measurement of more than five seconds for analysis 6 After measurement the data comparison screen is MVV DATA displayed The best data is automatically selected and marked O while the least well data is marked No MVV 901 16022524 7 Torepeat the MVV measurement repeat from procedure 1 8 Two 2 measurement data may be fully stored in memory sequenced as 1 gt 2 Subsequent measurement will overwrite the measurement data that is not marked O 8 10 POST BRONCHODILATOR TESTING This instrument is capable of performing post bronchodilator testing for each measurement 1 For single patient testing a Perform on the patient the V
31. Record 25 data sets A Pre Post data Record although assigned one tag number actually uses two record spaces when saved 8 16 PRINTING OF DATA Depress the PRINT key to print the current measurement result All the selected measurement data are printed on two print formats which can be user selected as standard or detail The procedure for selecting the print format can be referred to 8 17 OTHER FUNCTIONS To cancel printing depress the PRINT key 8 17 FUNCTIONS Depress the UTILITY key to display the menu screen MEMORY CALIBRATION TRANSMISSION BASE PRINT DATE MODE Select the desired function by keying the item number and depressing the ENT key to initiate operation Depress the STOP key to return to the ID screen 1 2 SE 4 5 6 8 Use the or keys to scroll through the screens 9 CONTRAST Page 34 of 66 Version 1 2 Memory File Function MEMORY MEMORY Select option 1 MEMORY from the UTILITY menu by keying the numerical label 1 and the ENT key 24 22 js LOAD to do memory filing functions saving loading DELETE deleting and printing of data Depress the STOP key to cancel and return to the ID screen Saving of Measurement Data SAVE Store or catalogue the current patient ID and measurement data into memory Select option 1 OK SAVE from the MEMORY menu to initiate TOTAL REST PRE Operation saves one data at a time
32. SPIROANALYZER ST 95 INSTRUCTION MANUAL FUKUDA SANGYO December 1999 Version 1 7 This Manual must be read carefully before using the PAGE REVISION LIST First Issue Page No Authorized By Geraldo S Sadian Re issued Geraldo S Sadian Re issued Geraldo S Sadian If you have any questions please call the local FUKUDA SANGYO products distributor or our office listed below Manufacturer FUKUDA SANGYO INC Address 2 L Kingsville Comm Arcade Marcos Highway Antipolo City PHILIPPINES Phone 632 645 8276 Fax 632 645 8276 Marketing Sales Coordinator FUKUDA SANGYO CO LTD Address 996 Nazukari Nagareyama City Chiba 270 0145 JAPAN Phone 81 471 46 9734 Fax 81 471 47 2193 Responsible for placing the devices on the EC Market under MDD 93 42 EEC FUKUDA SANGYO EUROPE s r l Address Via Germania 12 14 35127 Camin Padova ITALY Phone 39 49 870 3344 Fax 39 49 870 3388 Your local FUKUDA SANGYO product distributor please fill in your distributor details here Company Address EQUIPMENT SYMBOLS Reference EN 60 601 1 Appendix D Table DI IEC ISO 417 and Table D II IEC ISO 417 878 Direct Current DC Alternating Current AC Equipotential Ground OFF Power is disconnected from the mains ON Power is connected to the mains Type B applied part Page 4 of 66 Version 1 2 CONTENTS Chapter 1 CONTENTS CHAPTER I CONTEN ES ko
33. Successful REST POST data save operation is confirmed with the ID confirmation screen displayed Where the TYPE ENT KEY confirmation screen shows ID the ID number of the current measurement data saved OPERATION ID 1234567890 TOTAL the total number of data saved in the memory including the current data REST PRE the remaining memory capacity if only pre regular data are saved REST POST the remaining memory capacity if pre and post data are saved Reloading of Saved Measurement Data LOAD Reload a selected patient measurement data for 1 further operation Select option 2 LOAD from the Soe 0000000003 MEMORY menu to display the ID numbers of P 0000000004 data stored in the memory Select the patient ID 9 number and key in the prefixed item number and 0000006 depress the ENT key If there are seven data sets stored depress or arrow keys to scroll through the list of ID numbers stored in the memory Depress the STOP key to cancel and return to the ID screen Deletion of Measurement Data DELETE Deletes measurement data stored in the memory Select option 3 DELETE from the MEMORY 1 SELECT menu to initiate Select from two deletion options 2 ALL DELETE namely selective deletion or total deletion Selective deletes a specific data per operation While total deletes all data stored in the memory D 0000006 Page 35 of 66 Version 1 2
34. al keys and depress the ENT key to MONTH move the cursor to the successive item DAY HOUR MINUTE Depress the STOP key to end the DATE setting The screen returns ID screen This setting is backed up by battery until a new setting is made Setting of system mode MODE Select option 8 MODE from the UTILITY menu by keying the numerical label 8 and the ENT key to select desired prediction equations interpretation programs and measuring parameters Upon entering the current mode setting is ECCS displayed Depress the STOP key when DIAG change to the current setting is desired Else cm kg depress the ENT key to display the pop up e OC window screen When inside the pop up window So Ad screen use the A Or Y keys to move the cursor to ENGLISH the selected item requiring the change and Fleisch depress the ENT key to confirm selection Page 42 of 66 Version 1 2 ii iii iv OPERATION PRED specifies the predicted equation to apply Where applicable sets of prediction equations may be user selectable In cases ITS however that ITS or ITS NIOSH OSHA interpretation is selected only ITS prediction equation may be selected INTE specifies the interpretation algorithm to INTE use Where four 4 kinds of interpretation TTS may be user selectable NIOSH OSHA ELLIS SENSE gt Fleisch UNIT specifies the height and weight units that are used during pa
35. ama v d Woestijne K P Hunt R Bouhuys J APPL PHYSIOL 26 308 1969 5 Taussig L M Harris T R Lebowitz D AM REV RESPIR DIS 116 233 1977 ECCS Official Statement of the European Respiratory Society Standardized Lung Function Testing EUR RESPIR J 1983 6 Suppl 16 Page 61 of 66 Version 1 2 11 7 Parameter Sex VC 1 FVC 1 M M M F F F 1 1 M M M F F F FEV1 T 76 M M M 1 5 Symbol Definition H Height A Age Weight Age All 5 12 13 18 19 5 12 13 20 21 5 12 13 18 19 5 12 13 20 21 5 12 13 18 19 5 12 13 20 21 5 12 13 18 19 5 12 13 20 21 PREDICTED EQUATIONS Predicted Equation Remarks Pred VC Pred FVC 3 4300 0 429xH 8 8542 0 1572xA 0 668xH 8 3919 0 0143xA 0 0826xH 3 6955 0 442xH 6 6843 0 0672xA 0 0588xH 2 8821 0 0205xA 0 0465xH 2 6975 0 0353 8 4980 0 0927 0 0672 5 0391 0 0240 0 0594 3 2392 0 0391 5 4527 0 0332 0 0519 1 1219 0 0264 0 0327 103 6481 0 1147xH 71 077 0 8651xA 0 1821xH 74 564 0 2614xA 0 0996xH 96 073 0 0451xH 103 892 0 6766xA 0 023xH 114 015 0 2895xA 0 1306xH 2 7763 0 0388 10 6613 0 0927 0 1980 0 0496 0 0347 4 3043 0 0514 4 2533 0 0525 5 1952 0 0517 Page 62 of 66 Version 1 2 11 8 AUSTRIAN Param
36. ave procedure in 8 17 OTHER FUNCTIONS To redo the Bronchodilator measurement repeat the above measurement procedures 5 a through 5 d Bronchial Challenge print data Only previously catalogued measurement data during Bronchial Challenge testing mode may be printed The printout shall consist of base line measurement data each measurement data for Saline Inhalation and Dose Inhalation catalogued concentration value ratio of performance against the baseline data time duration from measurement of baseline data and graphed FEV1 changes To enable the foregoing printout depress the PRINT key or use the printing function of 8 17 OTHER FUNCTIONS Page 31 of 66 Version 1 2 OPERATION Cancellation of Bronchial Challenge Mode Cancellation of Bronchial Challenge test mode may be done through either of the following i Entering of a new patient ID using the ID key function After the entry of the full patient information the Bronchial Challenge Mode is automatically canceled ii Reloading of a patient data using the memory load function of 8 17 OTHER FUNCTIONS 8 12 DATA PROTECTION FROM OPERATIONAL ERROR Recovery from operational errors may be circumvented by the following 1 Inadvertent depressing of the ID key Whenever the ID key is depressed the ID screen readies for the next patient entry Depress the VC FVC or MVV key to return display of the last patient data However if the new patient data have been entered up
37. d User selectable between single copy and multiple copy 2 4 sheets printing FORM specifies the report format selection User selectable between STANDARD and EXTRA STANDARD prints in summary report form while EXTRA prints detail report form 1 STANDARD OnE ON 1 STANDARD FORM 1 PRED specifies whether inclusion of the predicted curve in the FVC print report is desired Standard setting is OFF If ON is selected the predicted curve is printed with the actual F V curve on the FVC graphical scale Page 41 of 66 Version 1 2 iv b 7 8 OPERATION INTER specifies whether inclusion of the interpretation summary in the print report is desired Standard setting is ON where the interpretation summary is inclusive in the print report If OFF 18 selected the interpretation summary will not be printed When the print setting is completed the setting screen is displayed Check the setting Depress the STOP key to end the print setting The screen returns to the ID screen Setting is backed up by battery until new setting is changed Setting of date and time DATE Select option 7 DATE from the UTILITY menu by keying the numerical label 7 and the ENT key to change date and time settings Upon entering the currently set date and time are DAT displayed A change may be made at the item Pete where the cursor is positioned Enter the change YEAR with the numer
38. e testing This test mode is kept until a new patient ID is selected Measurement with Saline Inhalation Omit this procedure and proceed to procedure 4 if the Saline measurement is not required Make the patient inhale Saline with a nebulizer as per prescribed dose Perform an FVC measurement similar to procedure 2 a to obtain a Saline control data If Saline Inhalation performance data is required catalogue the patient measurement data into memory by using the memory save procedure in 8 17 OTHER FUNCTIONS Measurement with Dose Inhalation Make the patient inhale Methacholine or the like with a nebulizer as per prescribed dose Note the administered dose in milligrams Depress the UTILITY key and select item 5 DOSE from the utility menu Enter the administered dose noted from procedure 4 a into the dose concentration screen using the numeral keys Depress the ENT key to confirm entry or use the CLR key to re enter The new concentration value is hence updated and the ID screen is displayed ready for re test A NO DATA message is momentarily displayed on screen if the Saline Inhalation Measurement was omitted The concentration entry is validated for values between the range The concentration value entered should always be higher than the currently registered value For instance if the current value was 0 08 the next acceptable value should be 0 09 Perform an FVC test then select and store the best data into the me
39. e flowhead slit With the flowhead rigidly with its front side towards you grasp the laminar tube with the free hand and rotate one eight clockwise to lock 10 4 NOSECLIP CLEANING The nose clip must be cleaned before each patient use with alcohol or a detergent solution Page 47 of 66 Version 1 2 Chapter 11 PREDICTED EQUATIONS 11 1 1 5 Intermountain Thoracic Society PREDICTED EQUATIONS Parameter Sex Age Predicted Equation 95 CI Reference VC Pred VC Pred FVC FVC 1 7 18W 3 58x10 4xH9 18 1000 13 1 Hsu 7 18B 0 1 07 103 298 1000 17 1 Hsu 19 0 0600xH 0 0214x A 4 650 1 12 1 7 18W 257 103 22 1000 14 1 Hsu 7 18 8 354 104 2 98 1000 15 1 Hsu 19 0 0491 0 0216 3 590 0 68 1 FEV 5 1 M 19 0 0327 0 0152 1 914 0 71 1 19 0 0238 0 0185 0 809 0 51 1 FEV1 1 7 18W 7 74 104 3 00 1000 13 1 Hsu 7 18B 1 03 103 222 1000 17 1 Hsu M 19 0 0414xH 0 0244xA 2 190 0 84 1 Crapo 718W 3 79 105 2 68 1000 14 1 Hsu 7 18 1 14x103xH289 1000 15 1 Hsu 19 0 0342 0 0255 1 578 0 56 1 Crapo FEV3 1 M 19 0 0535 0 0271 3 512 1 02 1 19 0 0442 0 0257 2 745 0 62 1 Crapo FEV1 G 19 0 1300xH 0 152xA 110 49 8 3 1 19 0 2020 0 252 126 58 9 1 1 FEV3 G M 19 0 0627 0 145
40. e patient Perform procedures 2 a through 2 b in acquiring measurements data saving and administration of medication to the other patients in repeated order To move on to post bronchodilator testing read out from memory the concerned patient measurement data using the procedures outlined in 8 17 OTHER FUNCTIONS Depress the POST key to set the patient pre bronchodilator data into memory afterwhich the patient ID screen is displayed The post bronchodilator test is now ready for the concerned patient Perform post bronchodilator test on the concerned patient using the same VC FVC or MVV test procedure desired The pre bronchodilator and post bronchodilator measurement data as well as the response rate are thereupon displayed Post is indicated on the comparison data screen In saving the pre and the post measurement data into the memory there will be two data sets consisting of pre data and post data for the same patient If the pre data is not necessary delete the pre data Repeat the same procedure of 2 d through 2 f to the other patients Enter a new patient ID to exit Post Bronchodilator Testing Page 28 of 66 Version 1 2 OPERATION 8 11 BRONCHIAL CHALLENGE TESTING This instrument is capable of performing Bronchial Challenge test Warning Prior to subjecting a patient to Bronchial Challenge Test check the condition of the patient the kind and dosage interval of the medicine allowable for the patient A
41. er or an improper maneuver depress the START key to re start the measurement from time zero and repeat from procedure 2 To abort measurement depress the CLR key Duration for VC measurement is fifty 50 seconds Depress the STOP key anytime you wish to terminate before the time limit Page 24 of 66 Version 1 2 OPERATION 7 After measurement the data comparison screen is VC DATA displayed The best data is automatically selected and marked If multiple measurements are No WO performed the second best data is marked O while 1 4 90 the least well data is marked _ 8 To repeat the VC measurement repeat from procedure 1 9 Three 3 measurement data may be fully stored in memory sequenced as 1 gt 2 3 Subsequent measurement will overwrite the measurement data that is not marked with or 8 8 FVC MEASUREMENT 1 Depress the FVC key to display the FVC comparison PVC DATA screen N EVE 2 Do not breathe into or move flow sensor while the instrument sets its zero level referencing at a NO FLOW CONDITION 4 16 3 Witha nose clip applied at the patient s nostril make UE the patient breath in and out in a normal rhythmic 1 8 manner into the flow sensor mouthpiece Depress the START key while urging the patient to continue normal breathing Respiratory waveform should now be seen in the screen 81 4 After normal cyc
42. eter VC FVC l FEV1 1 FEV1 G 96 PEF 1 8 75 1 5 MEF50 1 5 MEF25 1 5 TLC 1 kp Smp 2202 Symbol Definition H Height A Age W Weight Fi H W 3 Age All lt 17 218 lt 15 216 lt 17 218 lt 15 216 lt 17 218 lt 15 216 lt 17 218 lt 15 216 lt 17 218 lt 15 216 lt 17 218 lt 15 216 lt 17 218 lt 15 216 lt 17 218 lt 15 216 Unit PREDICTED EQUATIONS Predicted Equation Remarks Pred VC Pred FVC e 1 142 1 259xH 0 004070xAx W 4 11 606 8 172xH 0 0339xAxH 1 2869xIn A e 3 84244 1632x H 12 40 1485x A 2 1 322xFi 10 815 6 640xH 0 0408xAxH 1 7293xIn A e 1 178 1 221xH 0 003841xAx W 1 8 125 6 212xH 0 0300xAxH 0 9770xIn A 3 877 3 9809 5 0 1485 52 1 322 1 6 995 5 174xH 0 0314xAxH 1 0251x1n A 101 99 1 191x H 2 3 962xIn A 101 99 1 191x H 2 3 962xIn A 92 33 118 993 3 0320x H 2 6 9053xIn A e 0 214 0 921xH 0 0467xA 0 0020xW 1 798 2 311xIn H 0 0159xA 0 000248x A 2 2 e 0 411 1 793xIn H 0 4251xIn A 0 910xFi 1 832 1 838xIn H 0 0078xA 0 000172x A 2 2 e 0 077 0 770xH 0 0373xA 0 0025xW 1 581 1 854xIn H 0 0213xA 0 000283x A 2 2 e 0 455 1 616xIn H 0 3738xIn A 0 861xFi 1 779 1 421xIn H 0 0096xA 0 000179x A 2 2 e 0 522 0 843xH 0 0300xA 0 0035xW 1 490 1 290xIn H 0 0125xA 0 000218x A 2 2 e 0 25
43. he ENT key to toggle back 6 15 RECORD FILING IN MEMORY Patient data and measurement records are filed in memory using the memory save function under 8 17 OTHER FUNCTIONS 1 Recorded data consisting of a patient and i measurement data is automatically catalogued by a 0002 unique tag number and classified according to 0000000003 usage as shown where each row consists of a record 0000000004 entry The three columns showing the unique tag i 0000006 number record type and associated patient ID D 0000006 number respectively To view all records in storage SELECT use the Y or A keys to scroll over 2 Data records are chronologically stored and are classified in the following types Record Record space Description Type used 1 Pre Data Record P 2 Pre Post Data Record B 1 Baseline Data Record D 1 Dose Data Record 3 Where a Pre data record is created when saving the typical patient VC FVC MVV measurement data b Pre Post data record is created when saving a Post Bronchodilator measurement result Baseline data record is reclassified Pre data record that was utilized as baseline data for Bronchial Challenge Testing and d Dose data record is created whenever a dose test measurement result is saved Page 33 of 66 Version 1 2 OPERATION The maximum memory capacity of the instrument is as follows Record Type Maximum Memory Capacity Only Pre Data Record 50 data sets Pre Post Data
44. hree measurements are displayed The correction factor is then registered with the software Depress the ENT key to terminate the auto calibration routine OPERATION CALIBRATION Meas Exp 2470 Insp SOME Target 3 00 L TYPE ENT KEY The auto calibration acceptable tolerance is 1 liter from 3 0 liters Taken by averaging the three autocalibration measurements for both expiration and inspiration cycles reckoned from 3 0 liters If the average value is out of the acceptable tolerance an error message IMCOMPLETE will be displayed In this case depress the ENT key to return to ID menu screen and check the connection of the calibration syringe and the flow sensor Repeat the auto calibration routine In the event that the auto calibration procedure consistently results in an INCOMPLETE NG message submit your equipment for check up to your Fukuda Sangyo dealer Data transmission TRANSMISSION Select option 3 TRANSMISSION from the UTILITY menu by keying the numerical label 3 and the ENT key to conduct data transfer operation All the data stored in this instrument can be transferred to a PC using optional software FS PC 95 Contact your dealer about the detail specification for data transmission Before beginning data transmission check the connection of the PC and the status of data acceptance Depress 1 key 1 TX and then the ENT key to transfer data only Depress 2 key 2 WTX and
45. ide the tapered rubber tube smaller opening about 2cm deep A clean mouthpiece should be provided for each patient for proper infection control 3 After the instrument has warmed up the flow sensor s temperature is kept stable at approximately 37 C Hand check the flowhead temperature before passing the flow sensor to the patient 4 It is extremely important to explain if possible to demonstrate the correct measurement maneuver the patient has to undergo in order to obtain the best test result 5 Any time a VC FVC or MVV test routine is initiated the instrument performs zero level referencing at a NO FLOW CONDITION For a few moments during this time DO NOT breathe into or move the flow sensor to prevent the instrument from erroneously capturing zero reference at an offset Drifting of the waveform is generally caused by this improper action 6 2 POWERING ON The power switch of the instrument is located at the right side of the main unit Toggle the power switch towards the front marked Upon powering of the main unit the instrument boots up following the execution of a self test routine After a successful boot up an ID screen is displayed on the LCD If an error is detected however during self test the device halts and the error is displayed on the LCD Use the instrument only after a thirty minutes warm up time had elapsed for full electronic stabilization Page 21 of 66 Version 1 2 OPERATION 8 3 LOA
46. interpreted as a two decimal place number Key entry of the number is on a first in last out sequence where the DOSE 32 09 entered digit is positioned to where the underline is To enter a dose value of 1 32 mg enter 1 3 2 in sequence and depress the ENT key ENT KEY If you enter the wrong value depress the CLR key and enter the correct value The screen returns to the ID screen If you wish to cancel the DOSE entry depress the STOP key to return to the ID screen The last entered value is retained The entry values acceptable are listed in the following Type Description Accepted range Saline Measurement with inhalation of Saline 0 00 Dose Measurement with inhalation of Dose 0 01 to 999 98 Recovery Measurement with inhalation of bronchodilator 999 99 Page 40 of 66 Version 1 2 6 ii iii Setting of the Printout Format PRINT OPERATION Select option 6 PRINT from the UTILITY menu by keying the numerical label 6 and the ENT key to alter printing format of reports Upon initiation the current print format setting is displayed Depress the STOP key when no change to the current setting is desired Else depress the ENT key to display the pop up window screen When inside the pop up window screen use the A keys to move the cursor to the selected item requiring the change and depress the ENT key to confirm selection COPY specifies the number of report copies to be printe
47. lical breath immediately make 12 the patient breathe in to the fullest and then breathe out completely with force Direct the patient to continually breathe out all the air past five seconds Thereupon to breathe in again to the fullest at full force for Forced Inspiratory Vital Capacity measurement and then return to normal breathing Depress the STOP key to end the test Page 25 of 66 Version 1 2 OPERATION If the measurement is not satisfactory due to respiratory disorder or improper maneuver depress the START key to re start the measurement from zero time and repeat from procedure 2 To abort measurement depress the CLR key Duration for FVC measurement is twenty five 25 seconds Should you wish to terminate before the time limit press STOP key After measurement the data comparison screen is displayed The best data is automatically selected and marked If multiple measurements were performed the second best data is marked O while the least well data is marked _ To repeat the FVC measurement repeat from procedure 1 Three 3 measurement data may be fully stored in memory sequenced as 1 gt 2 3 Subsequent measurement will overwrite the measurement data that is not marked or O 8 9 MVV MEASUREMENT 1 Depress the MVV key to display the MVV comparison screen Do not breathe into or move the flow sensor while the instrument sets its zero level referencing at a NO FLOW C
48. lways have the bronchodilator ready during the test 1 Flow of measurement Measurement and registration of base line data Setting of baseline date BASE Saline Inhalation measurement and registration Control Dose Inhalation concentration values entry measurement and registration DOSE repeating up to certain concentration as may be required Bronchodilator Inhalation concentration value entry measurement and registration RECOVERY Printout of measurement result 2 Measurement and setting up of the patient baseline data a Measurement Perform FVC measurement on the patient to obtain a baseline data commonly the best data realized from the test VC and MVV tests may still be conducted however measurement results will not be printed on the Bronchial Challenge test report If required the appropriate procedures for report printing or data transfer should be done now Catalogue the patient Page 29 of 66 Version 1 2 OPERATION measurement data into memory by using the memory save procedure in 8 16 OTHER FUNCTIONS Setting up of the baseline data To start baseline data set up depress the UTILITY key and select item 5 BASE Select by using the numeral keys with the patient ID number earlier catalogued in procedure 2 a from the list of displayed ID numbers Depress the ENT key to now set the patient baseline data and upon display of the ID menu the instrument is now prepared for Bronchial Challeng
49. mended that calibration constancy be checked before and after each measurement session Prior to calibration remove the heater jack of the flow sensor from the main unit Page 36 of 66 Version 1 2 a OPERATION Connect the three liter calibration syringe to the flow sensor in a level line Pull back the shaft of the calibration syringe to its end and leave as is The zero level reference is detected at this time Do not move the shaft of the calibration syringe The calibration scale is displayed when ready 0 81 Depress the START key Push the shaft of the syringe smoothly to its end 12 to empty all three liters of air into the flow sensor d The flow volume curve is displayed on the scale 0 81 Then pull the shaft of the syringe smoothly to its end to take in three liters of air through the flow i sensor In auto calibration only the upper scale is shown on the display The inspired and expired flow curves are thus shown superimposed on the scale After a cycle the two flow curves disappear and the computer beeps 0 81 Repeat procedures 2 c through 2 d three times using varying speeds of emptying the calibration syringe to include flow linearity consistency If you wish to cancel auto calibration depress the STOP key The screen returns to the ID screen Page 37 of 66 Version 1 2 When the three calibration cycles are done the inspiratory and expiratory average values and correction factors of the t
50. menu by keying the numerical label 9 and the ENT Key to adjust the LCD display contrast a Upon entering the contrast display line is shown CONTRAST b Depress the key to darken or the key to lighten the display An mark will move right or left according to the contrast adjustment Depress the ENT key to end the contrast adjustment The screen returns to the ID menu screen Page 44 of 66 Version 1 2 SAFEKEEPING Chapter 9 SAFEKEEPING 9 1 Stowing For prolonged storage of the instrument the following prior action should be conducted 1 Insure that the instrument power switch is set to off Disconnect the power cord from a wall socket 2 Ifthe instrument is soiled wipe clean using a mild detergent dampen cloth Then wipe off with a dry cloth until no detergent remains 3 Do immerse the instrument in water expose to direct sunlight or subject to excessive vibration at any time 4 For best storage protection store the instrument in its original packaging and seal 5 Do not store the instrument on places where a large temperature humidity or pressure change occurs or where ambient dusts salts or ions are found 6 Check all the accessories and keep with the main unit Warning If the main unit or flow sensor is dropped it is mandatory that a thorough check of the system be performed by an authorized Fukuda Sangyo service personnel Further use of the i
51. mory For each concentration value where Dose Inhalation performance data is required catalogue the patient measurement data into memory by using the memory save procedure in 8 17 OTHER FUNCTIONS Page 30 of 66 Version 1 2 5 OPERATION Increase the dose as prescribed and repeat the above measurement of procedure 4 a through 4 e When the present FEV1 value should decrease less than 80 of the base line FEV1 data the following message is displayed FEV1 BL xx lt 80 Depress the ENT key to display the data screen Use the or keys to scroll through the measured values In any event that the FEV1 decreases abruptly discontinue further dose and proceed to Bronchodilator Inhalation Measurement with Bronchodilator Inhalation Omit this procedure if the Bronchodilator Inhalation is not required However administer Bronchodilator Inhalation to the patient for recovery Make the patient inhale Bronchodilator using a nebulizer as per required dose Depress the UTILITY key and select 5 DOSE Dose concentration screen is displayed and the last concentration value is displayed Enter the concentration value 99999 and depress the ENT key 999 99mg BRONCHODILATOR MEASUREMENT When the ID screen is displayed perform FVC measurement then select and store the best data into the memory If Bronchodilator Inhalation performance data is required catalogue the patient measurement data into memory by using the memory s
52. nsfer between the instrument and the patient is required to effect measurement Only differential pressure in the airflow path is used to capture the needed flow data 2 3 MEASUREMENT PRINCIPLE Tracking the patient s breathing effort the differential pressure generated in the flow sensor is transposed into an electrical signal by a piezo electric resistance type transducer The resulting analog waveform is then digitally traced by an Analog Digital Converter ADC and therewith recorded by the instrument s onboard microprocessor The microprocessor processes the digital data and memorizes the measurement data into the instrument s memory The requisite respiratory parametric readings are collated from the aforesaid digital measurement data and next displayed on the LCD printed on the built in printer or be transferred into a PC All the foregoing operations controlled by the essential switches on the Page 7 of 66 Version 1 2 INTRODUCTION front panel A heater is fitted in the flow sensor to avoid water condensation and to keep the respiration flow at simulated body temperature 2 4 BLOCK DIAGRAM KEY BOARD A D Converter CPU 16bit ROM 256KB LCD RAM 384KB SERIAL COMM PRINTER RS 232 Warning The compliance to the standards may be nullified by the following actions e Improper use of components not approved by the manufacturer Modifications or patches not expressly authorized by the manufacturer Interconnection t
53. nstrument should only be done after a satisfactory inspection Page 45 of 66 Version 1 2 CLEANING AND STERILIZING Chapter 10 CLEANING AND STERILIZING Before using the instrument and for each patient perform the following e Replace the paper mouthpiece disposable accessory Sterilize the laminar flow tube and the tapered rubber tube The laminar flow tube metal can be easily slipped out the flow head 10 1 CLEANING THE EXTERNAL OF THE INSTRUMENT arning Always unplug the instrument before cleaning Do not use any scrubbing agents or solvents alcohol acetone to clean the instrument or its accessories Generally any cleaning procedure that heats the materials above 45 C may affect the life of the material 1 You may clean the external surfaces of the instrument with a damp cloth or sponge safeguarding however that no drips flows along the surface of the instrument 2 Insure that the instrument is completely dry following a cleaning procedure 10 2 TAPERED RUBBER TUBE Pull out the rubber tube from the flow sensor to free 1 Do not use Ethylene Oxide gas to sterilize the tapered rubber tube The gas may cause incursion into the material where toxicity may remain 2 Do not use alcohol or alcohol based solutions to clean the tapered rubber tube These solutions may cause hardening of the material thus reduce the life of the material 3 The sterilization procedure for the tapered rubber tube can be
54. o outside equipment not explicitly sanctioned by the manufacturer The manufacturer is not responsible for any accident or damage occurring as a consequence of non observance of this warning Page 8 of 66 Version 1 2 Chapter 3 SPECIFICATIONS 3 1 CLASSIFICATION N e gt C2 3 2 MEASUREMENT SPECIFICATION 1 Type of protection against electric shock Degree of protection against electric shock Degree of protection against water penetration SPECIFICATIONS Class I equipment Type B applied part Ordinary equipment Degree of safety of application in the presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide Mode of operation Measurement Method Flow detection Volume detection Measurement range Flow range Volume range Measurement accuracy Flow Volume Measurements duration and times Vital Capacity Forced Vital Capacity Max Voluntary Ventilation Display LCD Printer Data memory Output RS 232C devices Not suitable equipment Continuous operation Pneumotach Flow Sensor Flow Integration 0 to 14 liters second 1 5 0 to 8 liters 1 5 indication or 0 2 1 5 whichever is greater 3 indication or 50 ml whichever is greater three 3 sets of 50 sec test three 3 sets of 25 sec test two 2 sets of 12 sec test 15 characters x 8 lines text 120 x 64 pixels graphics 32 characters line 46 characters second 58mm width
55. pared against various spirometric indices as determined from user selectable predicted equations The instrument has likewise the ability to do comparative analysis required in Pre post Medication and Bronchial Challenge Testing Regimens and a summary generation of hard copy reports for all the tests in a manner useful for clinical analysis The device has multiple patient data storage of up to fifty 50 patients that can be selectively stored into its built in memory With selected measurement results data and their corresponding waveforms may be electronically uploaded via the RS 232 port to a waiting Personal Computer PC Data Management Software FS PC 95 for the PC is available at an option Conventional fleish type pneumotach flow sensor is provided as a standard accessory and an optional disposal flow sensor may be used at your requisite Contraindication in the use of this instrument lies solely in the skill of the clinical technician to exact and be able to recognize a good patient effort and cooperation for optimal measurement results The multiple testing function of the instrument thus insures that a maximum training effect is achieved by the patient for measurement accuracy 2 2 INTENDED MEASURING METHOD Under room condition the patient is made to breathe air through the tubular portion of the flow sensor following a prearranged breathing maneuver Because the flow sensor is a low resistance free flow tube no real energy tra
56. ra vabo a a kabo aea de o aa bo dano 5 CHAPTER 2 INTRODUCTION 7 SR GUERRE D cep 2 2 INTENDED MEASURING METHOD id eh ro babe dE 7 23 MBASURBNMIENT PRINGIPLIRE he eta cad x 7 22 5 12 222 2 51 1 1 2 a a o DRE Mp 9 CHAPTERS SPECIFICATIONS 9 ATOS tee 9 3 2 MEASUREMENT SPECIFICATION o 9 5 CA 10 CHAPTER 4 PARTS IDENTIEICA 11 Zl MEATINSDIN ES N 11 SIRE seo o a o o 12 AS BOW SENS OR a aa ene A o 13 SOBIE Sipon 13 3 OPERAFONAE KE S o A a a Tal 14 CHAPTER 5 CAUTION S TTA A TRTRTTTTT oRobe a 15 GENE T TES 15 LO RU 15 53 BBBECTROMAGNELHIC CONIPATIBIDELY 15 543 BUSES N mo tese et Ce te ntu ma ed i tese e Mats e ELE 15 rinde us Lu keo mu 16 SO PAPER ss
57. ss the ENT key to display value of 10 under FVC or 0 1 the actual measurement result liter whichever is greater Coach the patient to exhale forcefully as soon the maximum inspired level is reached NO DATA No data is stored in the Depress the ENT key to return memory to the ID screen DATA OUTPUT NG Error in transmission of Depress the ENT key to return measurement data encountered ID screen Check interconnection with the host computer and retry data transmission 3 ID DATA FULL The memory capacity is full and Depress the ENT key to return unable to further store data to the ID screen Delete unnecessary data and retry the data storage procedure Page 66 of 66 Version 1 2
58. then the ENT key to transfer data and waveforms When either transmission is selected data transfer is started with following display Where the screen shows the total number of data stored and the number of data sets already transferred If you wish to cancel data transmission depress the STOP key to return to the ID screen TRANSMISSION Es ITX 2 WTX SELECT 3f WTX DATA OUTPUT WAIT XX Page 38 of 66 Version 1 2 If any problem is encountered during data transmission the following error message is displayed Depress the ENT key to return to the ID screen Fix the problem and repeat the data transmission procedure Entry of FRC value FRC Select option 4 FRC from the UTILITY menu by keying the numerical label 4 and the ENT key FRC value as measured by other Pulmonary Function Testing regimen may be entered Where RV value and associated parameters are computed from the entered FRC value and the VC data Enter the FRC value with the numeral keys On complete entry the FRC value is interpreted as a two decimal place number Key entry of the OPERATION WTX Communication NG KEK number is on first in last out sequence where the digit is positioned to where the underline is To enter an FRC value of 3 02 liters enter the 3 2 in sequence and depress the ENT key If an erroneous value is entered depress the CLR ke
59. tient ID entry Where selection may be Metric cm kg or English ins Ibs ENGLISH Fleisch TEMP specifies the temperature unit that is used during patient ID entry Where selection TEMP may be Centigrade C or Fahrenheit F e LANG ENGLISH SENSE Fleisch FEVx specifies which expression of FEV1 T FEV1 VC FEV3 T FEV3 VC or FEV1 G FEV1 FVC FEV3 G FEV3 FVC during FVC measurement to use Where FEVx T FEVx G may be selected ENGLISH Fleisch Page 43 of 66 Version 1 2 OPERATION PARA specifies which expression of Maximum Forced Flow on FVC PARA measurement to use Where MEFx or FEFx ME Fx may be selected FEFX PARA MEPS LANG ENGLISH SENSE gt Fleisch Vii LANG specifies the language to be use Where four 4 languages may be selected LANG ENGLISH GERMAN FRENCH SPANISH Fleisch vii SENS specifies the kind of sensor to be used Where FLEISCH or DISPO may be selected depending on the type of flowhead the patient intends to use MEFXx ENGLISH Fleisch b On completion of the mode setting the setting screen is displayed Check each setting Depress the STOP key to end the mode setting The screen returns to the ID screen The current setting is backed up by battery until a new setting is changed 9 Contrast Adjustment CONTRAST Select option 9 CONTRAST from the UTILITY
60. until you have cycled through the ID menu then to the pop up window you wish to correct Depress the CLR key and enter the correct value Then depress the ENT key repeatedly until you reach the end of the ID screen Page 23 of 66 Version 1 2 OPERATION 8 6 CANCELLING OF PATIENT S INFORMATION ENTRY 8 7 VC 1 This cancellation method of currently entered patient information is only possible when done before the RACE entry information is entered To cancel the patient information being entered depress any of the VC FVC or MVV keys The patient information is wholly canceled and the last patient data is displayed instead MEASUREMENT Depress the VC key to display the VC comparison a screen No VC Do not breathe into or move the flow sensor while the instrument sets zero level referencing at a NO FLOW CONDITION With a nose clip applied at the patient s nostril 31 make the patient breath in and out in a normal rhythmic manner into the flow sensor mouthpiece Depress the START key while urging the patient to continue normal breathing Respiratory waveform should now be seen in the screen The instrument then beeps after detecting three 3 81 normal cyclical breaths Immediately make the patient breathe in to the fullest then breathe out completely without force and thereupon return to normal breathing Depress the STOP key to end the test If the measurement is not satisfactory due to respiratory disord
61. ut 70 2 Keep away from prolonged exposure to fluorescent lighting 3 Not to be press stored alongside a PVC film 4 Contamination may occur on prolonged contact with a used thermal paper 5 Used thermal paper sheets should not be carelessly thrown away in the environment but should be subjected to disposal compliance of the present normative 5 6 PAPER MOUTHPIECE The rubber mouthpiece of this instrument will fit any commercially available paper mouthpiece used for this purpose Preference however may be limited to the following conditions 92 Not less than 23 6 mm in outer diameter Not less than 72 mm in length Not less than 1 6 mm paper thickness Steady and long term availability Page 16 of 66 Version 1 2 DISPLAY Chapter 6 DISPLAY 6 1 DEFINITION of Parameter Unit Printer Standard e e e 1 mw perv Tidal Volume Fonciona mc _ m o ulula o nc Ratio of RV divided by TLC RV TLC RV TLC ee uo Ratio of FEV3 divided FVC ww eme eme 20 e ve 2 0 1 Rati of divided tyFVC Rai of FIVI divided by FIVE Mid Forced Expiratory Flow at 25 75 MEF25 FEF75
62. y and enter correct value If you wish to cancel the FRC entry depress the STOP key to return to the ID screen Setting up Bronchial Challenge Testing BASE Entry of Concentration during Bronchial Challenge Testing DOSE Select option 5 BASE or DOSE from the UTILITY menu by keying the numerical label 5 and the ENT key to do Bronchial Challenge Testing After a baseline measurement data is loaded the instrument automatically changes into Bronchial Challenge testing mode Once this operation is entered the mode is kept until a new patient ID is entered Printing of Bronchial Challenge performance data may be done only after saving the data set as a DOSE set data Page 39 of 66 Version 1 2 OPERATION When in BASE option the ID numbers of earlier measured and saved patient data are displayed Enter the patient ID number using the prefix numerical tag number depress the ENT key When the ID screen is displayed the selected data is now loaded as the baseline data Bronchial Challenge Testing is now ready After administering the drug to the patient select option 1 DOSE from the UTILITY menu by keying the numerical label 5 and the ENT key The DOSE initial setting as displayed for a patient is pre set to 0 00 while subsequent settings displays the last entered value TX EE END REY Enter the concentration value administered to the patient with the numeral keys On complete entry the dose value is

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