（参考資料その1）（PDF:856KB）
Contents
1. OO2. ERROR 13
3. 1 ea
4. es CC ERROR XXX REF XXX ERROR
5. eo a ne TEL 03 3506 9486 6 3 58 EAX 03 3506 9543 http wwwinfo pmda gojp 3 3 21000BZY00722000 HIT 2009 9 28 7 2006 7 10 6 29 70655000 Z0 C0ZJ1MW Mitek VAPR
6. So ia MM
7. 2 http www jamdi org anzen index html 2 58 2 3 PMDA No 16 2010 4 http wwwjinfopmda_go jp 3
8. PMDA No 16 2010 4 http wwwjinfopmda_go jp 2 2 1 WW
9. 1 2 PMDA No 1 6 16 9 24 0924006 0924004 http www info pmda gojp gt gt gt PMDA
10. MTK202 07 3 7 8 9 10 11 12 13 14 A
11. 1 Et MTK202 07 37 38 39 40
12. 13 FAULT 14 14 2 500g
13. 3 58 10 1
14. 10 30 1 20
15. 1 2 4 58 1 4 1 6 1 DiN i 2 3 5mm mE 3 3 5mm 90 4 28mm
16. 2 3mm 3 5mm It 90 5 298mm a 6 2 3mm 45 3
17. MTK202 07 LDS ee 4 2 1 3 45 120 mL 3 5mm V2 90 60 130 90 90 3 5mm BV2 120 90 180 120 23mm V2 60 45 90 60 VAPR 3 VAPR 1 Mitek VAPR 3 221ADBZX00086000 Mitek VAPR 21000BZY00721000 2 1 2
18. 101 0065 3 5 2 03 4411 7911 101 0065 3 5 2 03 4411 7911 DePuy Mitek Gyrus Medical Ltd Gyrus ACMI Inc 4 4 7 58 OJ amp IJKK MTK202 07
19. 300 16 300 20 400 10 400 11 400 1292 400 18 6 58 3 4 FAULT Ref 400 14 400 15 400 16 LO00 1 400 18 400 19 400 20 OO 8 15 16 17 18 19 20 21 22 23 24 25 26 27 G8 29 30 GD G2 G3 G4 35 36 A FAULT
20. 0 1 2 INSERT ELECTRODE 3 OE 5 W
21. 2 1 3 4 6 1 2 3 4 1
22. CONNECT CABLE FAULT XXX REF XXX FAULT FEAULT 1 FAULT i a FAULT FAULT Ref 100 10 100 12 100 14 300 10 300 12 300 18 300 14
23. 2 MRI P1 lt 3 P4 7 P8 11 P12 14 P15 16 P17 24 P25 28 P29 32 P33 58 PMDA No 16 2010 4 http wwwjinfopmda_go jp HHHHH PMDA I 1 AM Sh ds
24. CONNECT CABLE INSERT ELECTRODEJ 8 INSERT ELECTRODE 6 RR I NA
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