5ラベリング 5-ー 添付文書く案) 川添付文書(案)を添付する。
Contents
1. 20 CW 980nm 30nmm 45D 21 JIS C 68022. JIS C 6802 4
3. 1 1 1 gt 1 Oh CK Jung DS Jang HS et al Endovenous Laser Surgery of the Incompetent Greater Saphenous Vein With a 980 nm Diode Laser Dermatol Surg 2003 29 1135 1140 2 Theivacumar N S et al Influence of Warfrin on the Success of Endovenous Laser Ablation EVLA of the Great Saphenous Vein GSV Eur J Vasc Endovasc Surg 2009 doi 10 1016 j ajvs 2009 05 022 3 Gerard JL Desgranges P etal Feasibility of ambulatory endovenous laser for the treatment of greater saphenous varicose veins one month outcome in a series of 20 outpatients J Mal Vasc 2002 27 222 225 4 Pannier F et al Mid term results following endovenous laser ablation EVLA of s
4. 3
5. 3 7 3 4 5 3 2 1 2 ELVeS 000000000000000 3 1cm
6. ABPI 0 9 1 Li 6 GaAs 980nm 30nm 635nmm 10nm 5mW 1W15W 0 1W
7. PARESTHESIA MAY OCCUR FROM THERMAL DAMAGE TO ADJACENT SENSORY NERVES WARNING TSSUE NOT TARGETED FOR TREATMENT MUST BE PROTECTED FROM INJURY BY DIRECT AND REFLECTED LASER ENERGY WITH APPROPRIATE EYE AND PROTECTVE WEAR FOR BOTH PATENT AND OPERATING PERSONNEL WARNING DO NOT REUSE THE FIBERS OR RE STERILIZE THE FIBERS PRECAUTION PRIOR TO AND DURING USE AVOID DAMAGING THE LASER FIBER BY STRIKNG STRESSING OR EXCESSIVE BENDING OF THE FIBER DO NOT COIL THE FIBER TIGHTER THAN A DIAMETER OF 20 CM CLINCIAL SAFETY AND EFFECTIVENESS DATAIS NOT AVAILABLE FOR OTHER FIBER TP D
8. 3 ELVeS 00000000000000 10 50 C 10 lt 909 700 1060hPa 1 gt 2 Theivacumar N S et al Influence of Warfrin on the Success of Endovenous Laser Ablation EVLA of the Great Saphenous Vein GSV Eur J Vasc Endovasc Surg 2009 dor10 1016 j ejvs 2009 05 022 3 Gerard JL Desgranges P etal Feasibility of ambulatory endovenous laser for the treatment of greater saphenous varicose veins one month outcome in a series of 20 outpatients
9. 4 7 5 Treatment Energy Treatment Time 2 Standby 3 4
10. ENERGY WITH APPROPRIATE PROTECTIVE WEAR FOR BOTH PATIENT AND OPERATING PERSONNEL 2 WARNING
11. 1 4 7 5 1
12. 5 5 7 8 9 TLA 10 TLA 11
13. 2 1 ELVeS INT01 01 2 1 1
14. 1 2 3 ABPI 0 9
15. TLA TLA 10mm TLA TLA 2 cm
16. 2cm 2cm lt 1cm 3 Enable 3 4
17. 2 3 20 20 20 3 8 9 ELVeS INT01 01 357 4
18. 2 ELVeS 000000000000000 3 1cm 4 5 6 7 8
19. 872 5 2 1 63 1 17 11 BN ELVeS 1 17 11 BN ELVeS LOT EOG 1 1 17 11 BN ELVeS
20. LOT EOG 1 AC100V 50 60Hz 110VA B 373
21. 1 2 3 ABPI 09 12
22. 13 45 10 5 1 10096 6 CEAP C2 C4a C4 C6 Evidence Summary C6 C6 1 81 59 100
23. 12 7 ELVeS INTO1 02 360 13 14 15 16 17
24. 10 50 C 10 lt 909 700 1060hPa 5 1 1
25. 2 3 ABPI 0 9 ELVeS 00000000000000
26. 6 7 8 TLA 9 TLA 10 11 7 12 13
27. 14 15 16 17 ES 18 19 20 CW 98
28. TLA TLA 02 368 TLA TLA 10mm TLA TLA
29. 1 2 AC100V 50 60Hz 110VA 3 4 1 B IPXO IPX8 1 4 260W x 380D x 220H mm 2 7 5kg 5 3
30. 6 1 1 2
31. 20mm 4 1 2 3 2 1 3 3 300 600 m 3 40 70
32. 13 14 15 16 1 18 amp s 19
33. PC 4mm ELVeS INT01 01 20mm 59 1096 1 1
34. 3 lt 7 ELVeS INT01 01 356 3 4 5 3 2 1 2 1cm 3 4 5
35. 62 55 88 7 120 35 56 5 24 37 1 12 19 4 7 11 3 6 9 7 CRP 5 8 1 3 4 8 2 3 2 2 3 2 1 1 6 1 1 6 1
36. 10 50 C 10 90 700 1060hPa 1 gt 2 Theivacumar N S et al Influence of Warfrin on the Success of Endovenous Laser Ablation EVLA of the Great Saphenous Vein QSV Eur J Vasc Endovasc Surg 2009 doi 10 1016 j ejvs 2009 05 022 3 Gerard JL Desgranges P et al Feasibility of ambulatory endovenous laser for the treatment of greater saphenous varicose veins one month outcome in a series of 20 outpatients J Mal Vasc 2002 27 222 225 4 Pannier F et al Mid term results following endovenous laser ablation EVLA of saphenous veins with a 980 nm diode laser Int Angiol 2008 Dec 27 6 475 81 5 AGUS GB et al The first 1000 cases of Italian Endovenous laser Working Group IEWG Rationale and long term outcomes for the 1999 2003 period International Angiology Vol 25 No 2 P 209 215 June 2006 1 17 11 BN
37. 2 I 3 7 3 2 1
38. 3 The Procedure 17 The Laser Fiber tip should be 17 7 1 centimeter below the Sapheno Femoral Juncton 1cm 1cm 365 2 2
39. 16 1 189 19 20 21 CW 980mm 30mm 4 5D 22
40. 2 3 2 1 2 3 3 1 300 600 4 m 4 40 70 cm cm
41. WARNING TREATMENT OF A VEIN LOCATED CLOSE TO THE SKIN SURFACE MAY RESULT IN SKIN BURN WARNING PARESTHESIA MAY OCCUR FROM THERMAL DAMAGE TO ADJACENT SENSORY NERVES WARNINGI TISSUE NOT TARGETED FOR TREATMENT MUST BE PROTECTED FROM INJURY BY DIRECT AND REFLEOCTED LASER 1 JIS C 6802 4
42. DO NOT REUSE OR RE STERILIZE THE FIBERS PRECAUTION PRIOR TO AND DURING USE AVOID DAMAGING THE LASER FIBER BY STRIKING STRESSING OR EXOESSIVE BENDING OF THE FIBER DO NOT COIL THE HBER TGHTER THAN A DIAMETEROF 20cm 20cm PRECAUTION APPROPRIATE PROTECTIVE
43. 3 S CIVIQ2 72 1 4 12 24 41 S 1 62 S 30 I 1 3 0 3 S 2 7 1 4 p 0 0000 5 1 62 100 96 896 95 296 6 I 1 9 S 2 5 8S S S 1 2 20 6 S 38 796 62 S 30
44. AILBK 1 iol sl sliooliol isgl isol iol is 2 5 ssl 4 ssl so ss eo esl al 7 3 333 233 26 aol 333 36 6 4 433 468 50 4 25175 2 225 25 zr5 3lszl 35 37s 1 mm 1cm A 4 1 0 035i 0 89mm 19G 2 TLA TLA 0 2
45. 3 370 1 1
46. ELVeS 00000000000000 700mm 1000mm 2 2 4mm 20mm ELVeS 000000000000000 ELVeS 000000000000000 1
47. 2 1cm 3 4 5 6 7 8 TLA Es 9 I TLA
48. PRECAUTION PRIOR TO AND DURING USE AVOID BENDING THE INTRODUCER SHEATH AS THIS CAN CAUSE KINKS AND DAMAGE PRECAUTION 1 ALL PERSONNEL IN THE TREATMENT ROOM MUST BE WEARING PROTECTIVE GLASSES WITH THE PROPER RATNG FOR THE WAVELENGTH 2 CW BEING USED 980nm 30nm 45D
49. EYEWEAR MUST BE WORN BY THE PATIENT PHYSICIAN AND 366 ANYONE IN THE TREATMENT ROOM CW 980nm 30nm 45D 367 3
50. 4 3 4 1cm 1 23 EN60825 4 4 1
51. 10 871 11 7 12
52. 1 2 3 7 3 4 5 3 2 1
53. Tel 03 3353 2630 Fax 03 3353 2672 Web http wwwr integralto CeramOptec GmbH ELVeS INT01 02 861 2010 5 28 13 000000000000 31 ELVeS JMDN 36546000 1 2 ELVeS 000000000000000 3 1cm 1
54. 3000mm 1 1mm 12 20mm ELVeS 000000000000000 ELVeS 000000000000000 1 1 2
55. INT01 01 359 2010 5 28 13 000000000000 31 ELVeS JMDN 36546000 1 2 ELVeS 000000000000000 3 1cm 1 1
56. 187 19 20 21 CW 980nm 30nmm 4 5D 22 3 ELVeS 00000000000000
57. 9 TLA 10 TLA 11 12 7 ELVeS INTO1 03 362 13 14 15
58. 2 596 CRP 5 6 1 2 7 1
59. 5 3x107 W nf 8596 NA 0 37 0 01 9 99 0 01 PN 980nmm
60. Treatment Energy Treatment Time 2 Standby 3 4 6 1 2 369 5 2 JIS C 6802
61. 319 1 62 S 30 1 S CIVIQ2 72 1 4 12 24 AUG S QOL Ts 1 60 S 30 I Y 7 16 S 6 97 p 0 4142 CIVIQ2 The Second version of the Chronic Venous Insufficiency Questionnaire QOL 21 S VFI S 4 62 S 30 4 5668 1815 6207 VFI Venous Filling Index
62. Leg ulcer treatment J Vasc Surg Mar 2009 804 808 13 Kontothanassis D et al Endovenous laser treatment of the small saphenous vein J Vasc Surg April 2008 973 979 14 Viarengo LMA et al Endovenous Laser Treatment for Varicose Veins in Patients with Active Ulcers Measurement of Intravenous and Perivenous Temperatures during the Procedure Dermatol surg 2007 1234 1241 15 Launois R et al Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency OIVIQ Qual Life Res 1996 5 539 554 16 45 4 Jpn Coll Angiol 2005 45 323 328 17 5 2002 22 29 lt gt 1 17 11 BN Tel 03 3353 2630 Fax 03 3353 2672 http www integralto 1 17 11 BN Tel 03 3353 2630 Fax 03 3353 2672 Web http www integralto CeramOptec GmbH ELVeS
63. J Mal Vasc 2002 27 222 225 4 Pannier F et al Mid term results following endovenous laser ablation EVLA of saphenous veins with a 980 nm diode laser Int Angiol 2008 Dec 27 6 475 81 5 AGUS GB et al The first 1000 cases of Italian Endovenous laser Working Group IEWG Rationale and long term outcomes for the 1999 2003 period International Angiology Vol 25 No 2 P 209 215 June 2006 1 17 11 BN Tel 03 3353 2630 Fax 03 3353 2672 Web http www integral to CeramOptec GmbH ELVeS INT01 03 363 2 2 1 WARNING TREATMENT OF A VEIN LOCATED CLOSE TO THE SKIN SURFACE MAY RESULT IN SKIN BURN WARNING
64. cm 1 mo ngi 2 5 35 4Q 45 50 69 6 7 5 3 333 233 266 333 366 4Q 433 466 50 4 25 ins ol225 25 275 so 325 3 1375 A 1 mm BB 1cm 4 1 0035i 089mm 19G 2
65. 2cm 1cm 3 Enable 3 4 1
66. 0nm 30nm 4 5D 21 3 ELVeS s 4 1
67. 5 5 1 1 2010 5 28 23 00000000000 31 ELVeS JMDN 36546000 1 2 JIS C 6802 4 3 4 1cm
68. ESIGNS AND 20 ELVeS 864
69. aphenous veins with a 980 nm diode laser Int Angiol 2008 Dec 27 6 475 81 5 AGUS GB et al The first 1000 cases of talian Endovenous laser Working Group IEWG Rationale and long term outcomes for the 1999 2003 period International Angiology Vol 25 No 2 P 209 215 June 2006 6 Mozes G Gloviczki P et al Extention of saphenous thrombus into the femoral vein A potential complication of new endovenous ablation techniques J Vasc Surg 2005 130 135 7 Proebstle TM et al Reduced recanalization rates of the great saphenous vein after endovenous laser treatment with increased energy dosing Definition of a threshold for the endovenous fluence equivalent J Vasc Surg Oct 2006 834 839 8 Desmyttere J et al Endovenous 980nm laser treatment of saphenous veins in a series of 500 patients J Vasc Surg Dec 2007 9 Min RJ Khilnani N Zimmet SE Endovenous Laser Treatment of Incompetent Great Saphenous Vein J Vasc Interv Radiol 2001 12 1167 1171 10 Rasmussen LH et al Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins Short term results J Vasc Surg Aug 2007 11 Theivacumar NS et al Endovenous laser ablation Does standard above knee greatsaphenaus vein ablation provide optimum results in patients with hoth above and below knee reflux A randomized controlled trial J Vasc Surg 2008 48 173 8 12 Coleridge Smith P D
Download Pdf Manuals
Related Search