添付文書 - Boston Scientific
Contents
1.2. 45 XX
3. dO
4. 1
5. Q2 lt 2 7 lt gt 6 1 2 3 4 5 7 8 X
6. 1 5cm X RO 0 5cm
7. dO
8. 2 Boston Scientifc Corporation
9. 1 EMC 0 d 5
10. X 2 3 4 Q
11. 7 Q 4 5 90998815 01A TPBS Atlantis SR Pro2 SC 107 7 10mL
12. 9 2 Se 3 5mm 3 Q
13. 13 00 9 d 5
14. Q lt 90998815 01A TPBS Atlantis SR Pro2 SC 107
15. 3mL 10mL 10mL 3mL 1 3mL 2
16. Y 4 23cm
17. 90998815 01A TPBS Atlantis SR Pro2 SC 107 gt 1 1 1 1
18. 5 7 m 8 1 19
19. d6 1 X 9 9
20. TIA 3 1 2 1 4 10 2 03 6853 1000 BOSTON SCIENTIFIC CORP
21. 105cm 2 6 a 90998815 01A TPBS Atlantis SR Pro2 9 gt E
22. 2 3 2 A E
23. CABG CABG PTCA PTCA i 1
24. FDA ALARA 1 30 in situ 30 in situ FDA FDA Information for Manufacturers Seeking Market Clearance of
25. Y 1 5 X 3cm
26. MI IEC IEC 60601 2 37 2007 Medical equlpment Part2 37 Particular requlrements for the basic safety and electrical essential performance of ultrasonic medical diagnostic and monitoring equipment 2 37 MI TT IVUS 6 7 IEC 60601 2 37 2007 LpaMPa li21 P mW 0083 Pes 1 2 Z 2 3 la EE RS EE I 00 0 1 A xcm o o8O em 1 o
27. i 5 0 36mm 0 014inch 1 63mm 0 064inch G 0
28. we 9 2 2 A em B
29. 6 X 7 1 90998815 01A TPBS Atlantis SR Pro2 SC 107
30. 1 1 0120 177 779 045 444 2844 90998815 01A TPBS Atlantis SR Pro2 SC 107
31. 1 0 GO 3
32. 0 6mm 1 ER 4 2 CE
33. 2 15cm lt 4 7 GE 6 7 7 6 Q
34. ijLab MDU5 TF FDA Information for Manufacturers Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers 2008 9 9 90998815 01A TPBS Atlantis SR Pro2 9 LTA3 Tcppa 3 mW cm W cm PL MPe 2 UN LWotmW 0 033 0 033 za em oos 00 xuem oo ye ooms DG oo58 looss RE zemo 1zeso BDS agem os55 LBew em oos9 28 7 23 4 17 9 16 0 6 7 3 7
35. B ISO10555 1 3 7 20800BZY00037000 ClearView Ultra bab 219ABBZX00239000 lilD 219ABBZX00238000 a lt Y 190 0 I i 1 63mm 0 064inch 0 36mm 0 014inch 3mL 10m
36. UD 1 1 7 d
37. 9 2 DAR 3 9 15cm 40MHz
38. MI P f Pg MHz Cm Z Z xy 6dB ClearView Ultra GalaxyM Galaxy iLab MD4 ClearView Ultraw MD5 MDU5 Galaxy Galaxy MDU5 iLab IEC 60601 2 37 2007 Boston Scientific Corporation IEC 60601 2 37 2007
39. C 2 7 Q 08 NA
40. 209228815 01 2014 11 7 11 21200BZY00484000 2013 6 17 10 51 70289004 70333009 13929001 35375001 Atlantis SR Pro Q Atlantis SR Pro CABG
41. Diagnostic Ultrasound Systems and Transducers September 9 2008 2008 9 9 MD TD IVUS in situ in situ Laexp 0 069fz 1 in situ MHz z 0 073cm in situ in situ 1 Atlantis SR Pro2 40 MHz a
42. L 21200BZY00484000 15 24cm 6inch 1 Q a RUNE 2
43. o 2 DS0G0 OO EE SS EE cm EE Wm 6 2 1 2 RE 1 28 7 23 4 17 9 16 0 6 7 3 7 n a n a MPa MHz mW n a cm cm Ms Hz MPa MI PraFawf 2 Cu IMPaMHz ea LMPa MHz mw na cm 12dB 6 tnteK cm Ms Hz LMPa Z MI 1
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