"取扱説明書"
Contents
1. 17 8 10 DEA 0310008 MIS T 14971 JIS T 0601 1 6 8 Cals 1 4 2 3 42 4 5 2 92. 6 16 169 af JIS T 14971 ITS T 14971 Calls 1 4 1
3. and Cnn _ o T 14971 1 4 2 3 4 2 4 v
4. MTS T 14971 JIS T 0601 1 1 6 1 5 17 3 10 0310008 L 16
5. GMP QI IMS 1 0330001 7 3 30 4 4 16 169 10 JAA OS HS REAR 1 5 1 4
6. 2 JIST0601 1 1 JIS T 0601 1 2 1 2 JIST0993 1 1 JIS C 1602 JIS B 7505 JISB8241 JIS B 8246 ASTM F882 84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 1SO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 3 JIS T 0601 1 JIS T 0601 1 2 JIS T 0993 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1
7. 5 30 ok 2
8. SB sin eT CRT SOLAR 16 169 GMP Q MS 0330001 17 3 3 4 4 a VERE 8 BN 1 5 1 5 3 GMP Q MS _ 0330001 17 8
9. 2 3 g _ CSA 0
10. 19 6MPa 30 421 2 JIS T 0993 1 1 4 2 1 3
11. 2 3 OE
12. 6 2 TEV 7 16 169
13. A HIS T 14971 IS T 0601 1 1 21 23 24 25 PBRAQIC PHP RE ZR ORD b On A
14. 38 SR 2 OR i Fl ei BIA 1 4 2 IS T 0601 1 1 10 2 2 49 IS T 0601 1 2 1 2 86 202 BK 1 4 2 5 4 2 5 1 4 2 5 2 UIS T 0601 1 1 56 11 d
15. 3 4 RHR 16 169 JIS T 0601 1 1
16. 2 2 2 GI 1 4 2 7 4 2 8 4 2 9 16 169 1 4 2 2 4 2 5 a
17. Ex 0 TERE Pac RAT O hte prone 1 4 2 7 4 2 8 4 2 9 2 3 siento aie ie 3 He HE acon RON R
18. BER B 16 169 IIS T 0601 1 44 7 8 16 eS eels
19. JIS T 0601 1 6 1 2 3 4 5 Hz V 6 A VA W 7 8 JIS T 0601 1 6 1 5 1 2 1 JIS T 0601 1 6 1 6 7 Le Ie 5 13 aaa eae IS T 0601 1 6 6
20. 3 2 33 3 4 3 5 3 6 4 4 1 JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specifi
21. IKEL HH WP 0 _ 2 JIS T 0601 1
22. RE ASTM F882 84 6 2 5 AC ASTM F882 84 6 2 6 JIST 0601 1 A1 6 ASTM F882 84 6 2 7 ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 QD
23. 16 169 4 amp 16 eee B 169 IS T 14971 5
24. 60 3 SC 4 2 8 ASTM F882 84 13 Test IMethod for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 8 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 3
25. SEE 86 201 6 JIS T 0601 1 2 1 2 86 202 oa ES Ls AO 2 HEC 19 20
26. 4 lar 5 UIS T 14971 GBIM 1 4 2 5 4 2 5 1 4 2 5 2
27. JISB 8246 42 5 ASTM F882 84 7 3 1 Cryogen Exhaust i 4 2 5 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 425 2 42 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentrati
28. ASTM F882 84 6 2 11 2 Si Le ee ee B 16 169 RAS On 1
29. 0331032 17 3 31 2 1 2 2 3
30. 2 mires ie cats oe 3 BEAR ah ORR IZOVYC 1 4 9 6 2 1 4 1 1 9 2 1 0 oe 1 7 2 1 6 0216002 4
31. 1 2 ARES BEATE OBS 4 2 1 2 4 2 IST 0601 1 1 43 1 MDIS T 14971 a MUBICRo CI 27 Beal x on 1 4 2 5 1 4 2 5 2 4 2 5
32. CELL 4 2 5 1 1
33. 10 56 3 a 57 58 BILE 1 4 2 3 4 2 4 MIS T 14971 5 0 NN ee 1 42 BU 1 4 2 2 EET 14
34. 2 1 7 3 3 1 0331012 BIL 2 5 7 16 298 1 955 19 3 2 1 2 1 3
35. ASTM F882 84 9 Test Method for Mechanical Integrity 3 5 5 JIS T 0601 1 25 43 1 44 4 45 4 2 1 1 2 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical Integrity ii 39 JIS B 8241 1
36. JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 4 2 2 ASTM F882 84 7 4 Thermal Insulation 42 3 ASTM F882 84 5 4 1 2 4 2 4
37. JIS GO eA Ne UA OR BIA 1 4 2 son STARA AEC A PATS ATL BERR 9 27 4 CE APS i 2 3
38. SC 4 5 ee 4 2 8 2 i RE Se 42 9 JIS B 7505 4 2 10 4 2 11 2S gg ISO10993 7 5 S 1 S 1 1
39. 1 PR 25 42 43 52 56 57 59 BIG 1 5 2 es 3 Spiel FA BIN HIST 1497T PERRET A 1 4 2 5
40. 3 TECNICA ORR Vs 4 4 BR Lav iB 5 6 BRE IRNT 2 RE BBCI LORI AICAES Y JR S HOBO BAIA 22 3 VW
41. 4 2 8 8 ne ee H 2 RN edn ag 3 4 AR a 5 NN JIS T 0601 1 2 1 ST DT WHATS DRI tS BREF IEO IT Z EBS 2
42. MIS T 14971 HIS T 14971 UIS T 0601 1 2 1 FR 2 SRD SEMA IV CVS KPA ORR 86 202 HIS T 14971 ERA A 2 7 UTS T 0601 1
43. 7 8 ei A PRI SX PRE CC AOR 12 IS T 14971 PS 5 a 1
44. 6 IS T 0601 1 1 44 4 56 11 d HIS T 14971 GIA 1 4 2 5 4 2 5 1 4 2 5 2 8
45. 0302012 amp 1 9 3 2 BR 3 5 1 4 5 1 4 1 19 2 1 1 4 9 1 9 2 5 I VD 1 1 7 2 1 6 0216002
46. 4 2 IS T 0601 1 7 bie JIS T 14971 ERE 0213001 15 2 13 A ARO aY i wel
47. EE 4 3 ep IS T 14971 pera nom oi IS T 0601 1 1 6 3 bs _
48. IS T 14971 IS T 0601 1 1 le 1 1 a 0 BA PERO HAO BE 2 Bett Re LE Oy FAPEDS BON RO AR Iz EK i GNA
49. 1 JIS T 0601 1 36 3 a 2 5 14 1 2 3 5 1 5 52 1 2 17 3 10 0310003 6 GB
50. 60 12 ASTM 12 2Sppm 42 6 60C 4 2 7 60 C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Rep
51. BG PED 7 iin ae ODM se ee 4 FERRRBRIC MAGA Etc ck Se _ aE 5
52. 8 4 4 BIA 1 4 2 10 8 Pe HS Zeit rite Zev ER SH i i oe lt oe ee oe 169 5 BORA LAST OR g BK 1 5 2 5 9 JAAR RRRR OSE RRS B nea ea MO 16 169
53. 169 ore 1 44 4 44 7 16 169 i T 0601 1 1 44 4 2 YY ae nee 3 ERPRRRRICM AGA ENECIEE BPS cr BY IA 9 f
54. 58 RiP SR 13 BRB GA Fede TIS T 0601 1 1 21 23 24 45 1 BI 4 2 IS T 14971 2
55. 4 5 47 6 1 495 0 ASTM F882 84 6 2 1 20 ASTM F882 84 6 2 3 ASTM F882 84 6 2 4
56. cation for Cryosurgical Medical Instruments 1 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 3 1 1 closed cryotip 5 4 Monitoring Devices 6 Disclosure Labeling and Documentation Requirements 7 2 Mechanical Integrity 7 3 1 Cryogen Exhaust 7 3 2 Ambient Concentrations of Nitrous Oxide 7 4 Thermal Insulation 9 Test Method for Mechanical Integrity 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 13 Test Method for Determining the NY of Temperature Monitors Cryotip and Tissue 42 42 1 JIS T0601 1 21 4 2 1 1 ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1
57. ire tag 4 2 5 2 1 5 3 718 T 0601 1 AB 6 15
58. on of Nitrous Oxide BRAM 1 1 28 32 2 13 42 17 0 3Oan REA 9Ocm 90cm 3 2
59. roducibility 3 1 1000mL 1000mL BIS 30 C 2C AB ww 4 2 3 4 S 6 7 3
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