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添付文書：90925547-01A

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3. AIR2 Alair AIR2 CS 8 LABA Alair
4. 1 2 1
5. NAO 4 10 2 03 6853 1000 90925547 01A TPBS Alair BT RF Controller ME 191
6. 4 Danek CJ et al 2004 Brown RH et al 2005 8 18
7. 1O UU 901 d
8. 188 A OFF ON EMC Alair RF ATS 200 RA AS ESD IEC 61000 4 2 SN IEC 61000 4 4 IEC 61000 4 5 IEC 60601
9. Dr 6 8
10. 1 1 3 1 1 3
11. ITT Alair 0 48 0 70 95 CI Alair 0 031 0 520 Alair 26 40 95 CI Alair 2 1 25 1 1 8 2 se SN iiil 0 0 H K Alair 1
12. 14 NSAIDs NN
13. 2 NN 90925547 01A TPBS Alair BT RF Controller ME 191 1 1 Danek CJ Lombard CM Dungworth DL Cox PG Miller JD Biggs MJ Keast Loomas BE Wizeman WJ Hogg JC Leff AR Reduction in airway hyperresponsiveness to methacholine by the application of RF energy in dogs J Appl Physiol 2004 97 5 1946 53 Brown RH Wizeman W Danek C Mitzner W Bffect of bronchial thermoplasty on airway distensibility Eur Respir J 2005 Aug 26 2 277 82 2
14. AIR2 Alair Alair 5 0 mL Alair 7 1 3 2 2 3 2 2 1 31 150 mL 5 2 0 133 12 Alair 0 230 12 Alair 0 086 12 0 028 12
15. d G5 6 1 ICD
16. ON OFF 2 90925547 01A TPBS Alair BT RF Controller ME 191 EMC A D RAM NC 188
17. 4 10 2 03 6853 0940 4 10 2 03 6853 1000 ISTBLLARTEBCH RESEARCH CORP Alarr ATS200 Alair
18. OFF ON 9 Q
19. Le NT 5 a 4 1
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21. m 150 MHz 80 MHz 800 MHz 80 MHz 800 MHz 2 5 GHz Ww d 3 5 V1 d 3 5 d 7 EL J P V1ly P y P io0 d m P W 0 1 80 MHz 800 MHz 2 3 V1 3 Vrms 4 E1 3 V m
22. 5 ON 16
23. 1 EN 60601 1 2006 EN 60601 1 2 2007 EN 60601 2 2 2009 1 ON 1 0 0
24. 3 6 12 46 ITT Alair 1 3 9 6 12 4 8 46 95 CI Alair 0 425 6 397
25. UEMC EMC dD 3 8 2 6 1 3
26. 2 400Bzxoo3se000 BSC 22400BZX00022000 1 10 15 cm
27. Alair 2 1 ICS 1 000 ug LABA 100 ug 7 Alair 3 3 6 12 6 9 12 3 90925547 01A TPBS Alair BT RF Controller ME 191 5 50 mg
28. Intent to Treat ITT Per Protocol PP ITT 1 PP ITT ye E 6 9 12 1 1 AIR2 Alair
29. 30 4 eS EMC 7 8 IEC 61000 4 1 1 lt 5 U gt 95 U 40 U 60 U 9 70 30 U 25 lt 5 U 295 Us 5 lt 5 Us gt 95 U 0 5 0 5 40 Us 60 U 70 Uz 30 U 25 lt 5 U gt 95 Us 5 na UT
30. M H UE EMC RF CISPR 11 RE A CISPR 11 i IEC 61000 3 3 RF IEC RF RF RF
31. 50 60 Hz IEC 61000 4 8 RF IEC 61000 4 6 RF IEC 61000 4 3 3 A m 3 Vrms 150 kHz 80 MHz 3 V m 80 MHz 2 5 GHz 3 A m 3 Vrms 3 V m RF ka d LATEP MHz 800 MHz d UI7IMTE MHz 800 MHz d R38 P MHz 2 5 GHz SS RNN W d m RF a 90925547 01A TPBS Alair BT RF Controller ME 191 7 1 80 MHz 800 MHz
32. 90925547 01A TPBS Alair BT RF Controller ME 191 1 6 2 3 8 _ So 0 5 10 RS232 lt gt 31 2 cm W x 39 1 cm D x 13 5 cm H 5 6 kg 0 2 100 200 VAC 50 60 Hz 1 0 A 1 CF SE IPX0 IP 6 2 8
33. i 6 0 95 CI Alair 0 01 0 001 95 CI Alair 0 11 0 83 95 CI Alair 0 025 0 172 2 Alair 95 CI Alair 4 0 27 3 Alair 3 7 15 3 95 CI Alar 4 6 19 7 Alair KN 2 UTT
34. Alair 0 062 12 0 075 12 AIR2 Alair 36 Aai 1 40 70 C 18 40 30 75 gt 800 hPa 1 1 Me
35. 2 a AM FM TV RE RF b 150 kHz 80 MHz 3 V m
36. AQLQ 6 9 12 AQLQ QOL AQLQ Alair 0 210 95 CI Alair 0 025 0 445 96 4 ITT 96 0 PP 97 9 PP NE QOL ITT PP AQLQ 1 AQLQ AQLQ 95 CI 0 210 ITT Alair N 190 N 98 PP Alair N 173 N 95 0 025 0 445 0 244 0 009 0 478 AIR2 Alar 6 Alair
37. 5 90925547 01A TPBS Alair BT RF Controller ME 191 1 2 1 OFF 2
38. 90925547 01A TPBS Alair BT RE Controller ME 191 6 6 12 288 Alair 3 2 2 Alair 3 Sa a 84 i aa Fs 1 1 esT15s 3 2 4 8 rm CE a 4 EE 52 39 27 4 15 14 18 3 1 i2 1 5 5 9 0 2 11 8 2 3 6 7 9 3 4 _ 5 0 0 4 2 7 5 J II 5 6 3 5 6 6
39. 12 Alair 1 3 Alair 1 3 5 8
40. 2920925547 01 2014 10 28 1 22600BZX00386000 51 44775003 Alair Alair

添付文書：90925547-01A

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