Vigilance II - Edwards Lifesciences
Contents
1. P 12. IEC EN 60601 1 1 IEC EN 60950 IEC EN 60601 1 IEC EN 60601 1 1 IEC EN 60950 1 5
3. CCO CCI Edwards Lifesciences 7 4 1 CCO 1 2 7 7
4. ICO Edwards Lifesciences 8 6 1 ICO 1 2 8 13 Il
5. 1 2 2 1 d
6. EO gt BP P II Edwards Lifesciences 2 3 2 1 2 2 ee 5 Edwards Lifesciences a _ nn ik Vigilance I 2 1 i CF F
7. CCO ICO CEDV RVEF SV SVR 1 4 OEdwards Lifesciences Visilance amp N Y 1I O 2 CCO ECG X3 a I 1 1 1 1
8. A 4 4 Edwards Lifesciences 4 8 4 8 1 POST POST POST 4 8 2 100 240V AC 1
9. 2 Edwards Lifesciences 5 4 OEdwards Lifesciences Vigilance
10. 1 2 3 1 4
11. 1 2 3 4
12. gt BP BP SVR VQI O02EI MAP CVP Sa02 MAP CVP SaO2 SVR VQI OsEI MAP CVP SaOz
13. Edwards Lifesciences 1 1 5 _ 1 2 1 3
14. D Edwards Lifesciences
15. 1 2 8 16 8 17 ICO 1 2 Edwards Lifesciences 8 17 CO
16. a STAT 2 5 8 Edwards Lifesciences 5 3 2 ICO CCO ICO ICO 5 5 CCO ICO COavg Clavg ei 15 46 45 24 8 2005 5 5 ICO 5 5 5 4
17. 14 8 2 CCO 4 ew ICO i 3 ES z a gt gt 8 2 CCO 1 CCO Edwards 2 CCO i 8 3
18. Edwards Lifesciences iii Edwards Lifesciences 1 2 3 2 8082816X8 818283SISDSISG82826 71836287948 HSISUSPS5SPSC5828PSK8z8Y s8 87SISkSiei828PSii 0 0 OY 1 1 1 1 RE SE RR I SRE a Ea EN EERE SE nta 1 2 1 1 1 CCO ee 1 2 1 1 2 ICO ee 1 2 1 1 3 CEDV 88 38280aeSNSCet8a2eignaeiena 1 2 1 1 4 SvO gt ScvO2 TR RE RE EE 1 2 1 1 5 1 3 12 8 1 3 1 3 SRE RE EGE EE EE 1 3 1 4 OT OE nO 1 3 1 5 EE EE EE 1 4 1 6 0 ER 02007 70RD 1 5 RE RRR RR RR RE RR CR ER ERR CR CR RCRA 2 1 2 1 SI SERED EE SEES SEE CES I EE 2 2 2 2 tete 2 2 1 Se SR a RS EG Gn SS SE 2 2 2 2 2 RSS ER GE SE ER ERR RE SE 2 5 2 3
19. CCO CO CCO SvO2 Edwards CCO CCO 14 Edwards CCO CCO
20. 1 RE RN RD 1 3 4 SVR DO2 ESV ESV SVRI VO2 ESVI ESVI MAP Sa02 Sa02 CVP CVP MIAP 2 Edwards Lifesciences 5 10 5 11 ap 2 RVEF PVR DO ESV PVRI VO2 ESVI LVSWI VO4 ESV HRavg SV RVSWI OE SV PVR SVI Sa02 OZER MAP Sa02 SVR Ca02 VQl CVP SVRI CvO2 HRavg Ca vO2 CVDP DO2
21. STAT STAT 2 RS 232 USB
22. 1 2 Edwards Lifesciences iC ES2A 3 CCO 3 4
23. Al CCO gt BP BP BP BP Edwards Lifesciences
24. 8 16 1 CO 1 25 gt 1 5 mL 10mL 8 17 2
25. CO 1 2 2 e e 3 4 8 3 3 1 2 3 e3 mL e5mL e10 mL 3
26. Edwards Lifesciences 8 7 8 4 8 4 1 ICO 1 6 CCO CCO ICO 1 CCO ICO ICO 8 6
27. COavg CO CIavg 4 SQI IL SvyO2 ScvO2 CCO 1 COavg 3 CO CI 6 5 11
28. 8 6 3 1 2 CO ez ps g 8B 18 8 18 Edwards Lifesciences ICO 8 6 4
29. CCO 1 25 1 5 mL CCO 2 7 10 CCO Edwards Lifesciences CCO 7 4 3 1 2 7 11 CCO Es EY 7 11
30. Sv0 11 5 gidL 35 OM HGB 3 2 Edwards Lifesciences 3 3 10 1 12 HGB Hct HGB
31. a RE ER TRCN ER RRR 5 3 5 3 5 2 1 teeter 5 3 5 2 2 5 5 5 7 5 3 1 CCO PP TD ssdiais 5 7 5 3 2 ICO DE I 2 ISSN 5 9 EG RE EE NNE CE STS 5 11 CCO 5 11 5 5 1 5 13 5 5 1 1 RE I RE RS Ee 5 13 5 5 1 2 DE EE EE CE 5 13 5 5 1 3 ee 5 14 5 5 1 4 P07 P00 5 14 ICO RE EI EI RS SE REC RR side1e78 ae 5 15 BT 5 16 IT ICO i RT RS TE i 5 16 E DIN TD SS GS 5 16 5 9 1
32. CO CI CO CT CO CT 8 5 CCO 1 CCO ICO CCO NN CCO CCO CCO
33. 7 3 CCO CCO CCO e e e 7 3 1 CCO CO CCO CCO
34. Ac LED AC AC CO ICO CCO CCO ICO CCO ICO 2 1
35. CCO 5 20 Edwards Lifesciences 5 12 CCO STAT BOX e e a
36. Edwards Lifesciences ECG ECG CO 14 15 16 17 CEDV ECG 1 4 ECG BCG CO CCO CEDV ECG CEDV CCO BSA STAT
37. 7 CIC3 6 6 Edwards Lifesciences 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 5 11 5 12 5 13 5 14 5 15
38. 5 3 1 CCO CCO 5 3 5 3 5 3 CCO CCO 5 3 5 4 1 4 5 4 CCO Edwards Lifesciences 5 7
39. PA CO CI 3 CO 3 a 5 4 4
40. 4 9 30 06 25 8 2005 9 37 20 25 8 2005 i 1 1 6 11 5 6 16 Edwards Lifesciences 7 2 7 3 7 4 7 1 7 2 7 3 7 4 7 5 7 6 7 7 7 8 7 9 7 10 7 11 CCO 7 CCO SE SE SS EERE SR SE 7 2 DSR SEES nai en Sa Ea ST SR ai a Sn a ai 7 3 CCO etre 7 4 7 3 1 a EE 7 4 7 3 2 CCO ee 7 5 7 3 3 CCO STAT BOX 7 6 7 3 4 CCO i RE EE R
41. CO 1 1 2 ICO CO PA Stewart Hamilton
42. 7 4 4 2 7 4 5 ICO CCO ICO CCO ICO ICO CCOICO 8 ICO NN 7 4 6 _ CCO CCO
43. 6 8 Edwards Lifesciences 6 5 6 2 6 2 a e
44. t 24 3 4 Edwards Lifesciences 6 7 6 4 4 1 2 24 25 08 2005 3
45. 5 6 AN 7 CCO CCO CCO STAT CCO 8 ICO ICO
46. 4 8 6 Edwards Lifesciences ICO 8 3 4 1 2 5 5 5F e 6F s 7F 7 5F e 8F 3 4
47. CCO CEDV SVR CO 8 13 3 CO 4 CO CO CCO CEDY SVR 8 14 CO CO Edwards Lifesciences ICO 8 14 ICO
48. 6 6 5 6 7 6 7 6 7 1 MAP CVP SaO2 HRavg Edwards Lifescie
49. Edwards Lifesciences Edwards Vigilance ll 3 1 3 4 5 SvO2 20 6 7 SvO2 ScvO2 8
50. xx xx 20 1 1 OK xx CCO 13 CCO CCO
51. 72 4 4 CCO 1 CCO EDV RVEF Edwards Lifesciences 6 3 6 3 5 E Vigilance ll 6 3
52. CCO 1 0Limin CCOICO CCO 7 9 CCO 2 Edwards Lifesciences 7 9 7 4 2 CCO 1 1 2
53. CCO CEDV SVR CO 7 7 3 CCO 4 CCO 7 gt HA 8 CCO CEDV SVR CO 7 8 CCO CCO Edwards Lifesciences CCO 7 8 CCO
54. ee 7 11 Edwards Lifesciences 7 1 CCO CCO 1 CCO 60 STAT BOX STAT CCO CCO 2 4 CCO 5 cco 10 24 10 29 1034 1039 1044 10 49 10 54 STAT BOX 0 35 634 5 38 4 42 3 45 2 49 1
55. 7 10 I Eg 7 10 CCO 2 CCO
56. CO CI 1 6 0 30 2 6 0 3 0 8 1 ICO SvO2 ScvO2 CCO 1 8 2 ICO Edwards 8 2 1 CCO Ez 8 2 Edwards Lifesciences ICO CCO CCO
57. 4 3 4 1 CCO TTTTTTTTTTTTITTTTT 6 0 NN I O X 2 ECG CCO X 3 i em mm mm mi EEOEEiEifK OO a I a d 4 1 4 4 4 2 Edwards Lifesciences 4 5 4 6 4 1 RVEF SVR lco O O Edwards Edwards CCO ECG
58. 2 2 Edwards Lifesciences 1 5 1 6 Edwards Lifesciences 2 1 2 2 2 3 2 4 2 5 2 1 2 2 L 2 88088 8 2 2 2 2 2 2 1 ee 2 2 2922 WS SSR RIGO CNS CIEE EEN SSR CRASS ISIS NN NOG RRR N S a 2 5 Occeeteteseteseseeeesereatereeeraeere 2 8 0 EE RSG 2 10 i eR RE EE DI RI SI EIR ENE A OS TIE RRA 2 11 SS aa 2 8 Si 2 9 Edwards Lifesciences 2 1 2 2
59. ICO Edwards Lifesciences 9 10 11 12 13 14 A B C D E F G H 1 CEDV RVEF CEDV RVEF ECG STAT CEDV RVEF SvO2 ScvO2 OM
60. 2 ER 1 3 4 SVR ESV SVRI ESVI MAP Sa02 Sa02 CvP CVD NL MAP 3 4 AE JUN 3 RVEF PVR DO ESV PVRI VO2 ESVI LVSWI VO SV RVSWI OH SVI Sa02 OZER SVR Ca02 val SVRI CuO02 HRavg Ca vO2 CVP DO2 MAE Edwards Lifesciences 5 17 5
61. MPAP 9 30 06 25 8 2005 CCO 5 5 Hmin PWR 71 dn sicms ccl 2 5 Lirminirms PYRI 15 dh s mcms 9 32 25 MAP 3 mmHa LV8Wl 41 grmimsb 2 RW 4 9 mirmh 25 8 2005 Sy 77 mLUh SMl 3B mLli bims PD REF 3 0 182 cm EDy 197 mL 1 kg ED 3 mlirmz BA 2 13 mz ESY 120 mL SWR 1354 dh sicms ES 55 mlims SVRI 26B5 dn s micms 6 8 4 1
62. Pa CO CI 8 5 Edwards Lifesciences 8 11 1 CCO ICO CCOICO tl CCO 2 CCO 3 CCO CCO B ICO ICO CO
63. 11 4 10 95 RH A ck 2 BRSc 2 10 Edwards Lifesciences 2 5
64. SvO2 CCO CO SaO2 CCI CI PvO2 SvO2 ScvO2 PaO2 HGB FiO2 PvOz Pa0z FiOz FA 6 7 4
65. 5 9 1 8 1 1 5 12 5 16 Edwards Lifesciences EE i 1 RVEF PVR DO4 ESV PVRI VO2 ESVI LVSWMI VO4 SVR MAP SV RVSWI OEI ESV Sa02 SVI Sa02 OzER SVRI CVP SVR Ca02 val ESVI SVRI CyvO HRavg Ca vO02 CVP DO2 5 12 1
66. IL 0 tt 4 HRavg EDV EDVI ESV ESVI RVEF 4 Edwards Lifesciences 6 7 3
67. 8 2 4 Cs AC AC LED A a 7 o 3 3 10 SO gt CCO ICO min e B gt 2 5 SVO2 My ED 2 gt 7 CCO 14 40 2 2 8 Edwards Lifesciences
68. CCO 11 STAT 5 15 6 2 1 5 5 1 2 Edwards Lifesciences 5 23 5 24 Edwards Lifesciences 6 1 6 2 6
69. 4 2 3 5 14 Edwards Lifesciences 5 6 v ICO ICO 1 2 COavg 5 10
70. ICO 1 1 3 CEDV CCO RVEF ECG CEDV 1 4 SvO2 ScvO2 LED Sv02 Scv02
71. PA CO CI
72. 10 5 ee 10 6 er 10 6 ooo 10 8 mee 10 9 10 9 ee 10 10 oe 10 10 10 11 HGB oooeeerrnrnrrert 10 12 NE OC 10 16 ee 10 16 2 1 ee 10 17 2 2 ee 10 17 SQI 4 ee 10 18 NRy 11 3 11 4
73. ee 5 17 5 19 CS RIS ST DS NR Ee 6 2 eiseeseeeeeeeeteeereeeeee 6 3 erosreererreeeeeeeeeeeteeeeeseeeeeeeeeeeeeee 6 4 BSA 6 5 ee 6 6 ere 6 11 ieee 6 12 6 13 6 14 ee 6 14 Da NE DNS EG 6 16 CCO te 7 2 CCO 7 3 Edwards Lifesciences Xi Xii 7 3 7 4 7 5 7 6 7 7 7 8 7 9 7 10 7 11 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 8 9 8 10 8 11 8 12
74. 67 170cm 170 6 4 Edwards Lifesciences 5 67 170cm _ kg 6 183 lbs 83kg BSA 7 8 Edwards Vigilance Il 152 cm BSA 1 65 mi 6 4
75. CO CI 8 5 8 4 2 ICO CCO 1 CCO ICO ICO 2 CcOICO RN 3 4 CO
76. e e e CCO 7 4 7 2 e e eSV 7 4 7 3 e CCI CCO e Vigilance II MAP CVP e SVRI SVR 7 12 Edwards Lifesciences 8 1 8 2 8 3 8 4 8 5 8 6 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 8 9 8 10 8 11 8 12 8 13 8 14 8 15 8 16 8 17 8 18 ICO IR SS CE RE RA 8 2 8 2 1 _ CCO 8 2 8 2 2 8 4 EIR RR RR NE RI RR 8 4 8 3 1 ttre 8 5 8 3 2 YY EER CD EI CT So ES 8 6 8
77. 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 5 11 5 12 5 13 5 1 5 2 5 3 5 4 5 5 5 6 ete 5 3 5 5 CCO ee 5 7 CCO ee 7 ICO ee 5 9 ee 5 11 SvyO2 5 12 5 13 ICO 1 2 nene 5 15 ICO 3 5 16 5 17 es AEROaereeeak 5 19 5 4 5 6 COO ee 5 8 ICO
78. 6 7 8 6 8 5 9 2 1 4
79. 45dB A 85dB A 3 CCO 1 2
80. 8 2 IT 8 3 D
81. 5 3 5 3 CCO CCO io BSA BT FF NR a
82. BSA Dubois Dubois BSA BSA BSA BSA Edwards Lifesciences 6 5 6 3 2 BSA 1 7 BSA 1 2 BSA 1 95m
83. e e e 1 6 9 9 30 06 25 8 20
84. AC 9 amp oY 2 3 4 4 2 2 Edwards Vigilance Il VG000000 Copyright 2004 Edwards Lifesciences LLC 10 4 4 4 POST 5 F Edwards Lifesciences 4 5 Edwards Vigilance Il Italiano Nederlands English UK Espanol Portugues Francais a 41 Deutsch ans Cestina 4 5 6 i i 4 5
85. 8 3 SvO2 Edwards Lifesciences 8 3 3 Edwards 8 2 2 CCO 8 2 e CO Set e CCO
86. 8 4 Edwards Lifesciences ICO ICO 2 ICO 8 4 St i r COavg 10mL 8F 8B 4 8 3 1 COavg CIavg 2
87. ng ES Sr Svo2 2 ScvO2 2 CCO L min 60 CCI L min m 60 CO L min CI L min m mL mL m Clavg dynes sec cm kPa secL dynes sec mcm 2 kPa sec m2L 1 mL beat 1 mL beat m 60 60 SVI 5 12 Edwards Lifesciences 2
88. 6 7 9 30 06 25 8 2005 CCO 5 5 Hmin FwR 71 dn sicms CCI 2 6 mih PWRI 150 dm s Im2Ems 9 31 15 MAP 3 ImmHg LSW 41 ImJFm2h PAP 14 mmHq RY SA 4 9g mimsib 25 8 2005 CvP 5 mmHg SV 77 mLh PAWWP mmHa SVl 36 mL HRawd 73 bpm RWEF 3 182 cm EDy 197 mL 1 kd EDMI 3 mm SA 2 13 me ESY 120 mL SVR 1254 dn sicms EBI 5 mlirmz SVRI 2B65 HI S Im Em5 6 7 2 CCO CO PAWP CCI CI HRavg MAP MPAP CVP BSA BSA MPAP PAWP Il Edwards Lifesciences 3
89. 5 6 1 2 7 9 CCO 1 2 CCO lt 31 C gt 41 C CCO
90. Se2828He09EiSSrSIS8iR28 eS28RSSaie 6 11 oo 6 12 6 13 6 14 NS SS SEE SE CE 6 14 ee 6 16 ee 6 3 te 6 9 Edwards Lifesciences 6 1 6 2 6 6 2 1 POST 6 1 OE Edwards Vigilance Il VG0000
91. 5 16 5 9 2 5 18 2707207 2 7 5 19 00 0 5 19 RA RS RE RD SE SR ED REESE CR 5 21 5 12 1 etre 5 21 5122 STAT BOX oo 5 21 5 12 3 RE SRS CS ES EER RI RIRS RNR SS 5 21 5 12 4 5 21 5 12 5 mm 5 21 5 22 5 13 1 5 22 5 13 2 STAT 5 22 5 13 3 ICO RR 338 5 22 5 22 CPPFPPPPPFFPFPTF Fr PF 5 23 5 15 1 5 23 5 15 2 CO a a eR GR SE A SS SIS NE ES 5 23 5 15 3 CCO ICO TES EE NE GNC 5 23 5 15 4 2 700 2 7 5 23 5 15 5 5 23 5 15 6 eters 5 23 Edwards Lifesciences
92. A 4 2
93. B ICO ICO CO CO CT 8 5 Edwards Lifesciences 8 5 8 6 ICO CO CI 8 12 2 CO CI 38 8 2005 65 32 15 11 28 25 8 2005 5 H 3 H 8B 12 0
94. 5 6 8 15 ICO 8 6 2 ICO 1 2 CO 8 15 ICO ICO
95. Edwards Lifesciences 1 3 1 5 1 1 1 1 AAMI ICU AC IEC ANSI I O BSA ISTA BT IT ABT LED Ca vO2 CaOz CvOz LVSWI 1 CaO2 MAP CCO MPAP CCI Oz2ER CI OzEI Clavg OM CO PA COavg PaO2 CVC PAO2 CvOz PAWP CVP POST DC
96. CO CCO CCO CCO 7 4 Edwards Lifesciences 7 5 7 4 CCO CCO _ SvOs EDV__RVEF 12 0 1 200 1oo SvO2 4 62 65 5o 100 so 1 45 1 01 0 o Lo BT 36 9 1 50p 135p 200p 205p 210p 215p 220p SVR 1214 ESV 73 PPARDOEIE 10 54 14 25 8 2005 0 7 5 7 3 3 CCO STAT BOX CCO CCO CCI STAT
97. 6 1 6 1 e e e e e e e e 72 72
98. 7 11 7 4 7 CCO CCI SE EE SR 7 12 7 4 7 1 7 12 7 4 7 2 POP TP 7 7 12 7 4 7 3 eee 7 12 Edwards Lifesciences Vii Viii 8 9 ICO I 0 OR CIR OR eI eR RN RR Re 8 1 8 1 RE SR ETE ER RE ES RR EE 8 2 8 2 iene sittin 8 2 8 2 1 CCO SS 8 2 8 2 2 SS 8 4 8 3 RE ST I I I RG SS ER 8 4 8 3 1 eS SE EE RSE EE EE 8 5 8 3 2 CE SEER RR SR RS 8 6 8 3 3 SS 8 6 8 3 4 SS 8 7 8 3 5 ns Sas ERS GS GET RE RE 8 7 8 4 RR RN ER 8 8 8 4 1 ICO eR ei eR EE i 8 8 8 4 2 ICO SS EE 8 12 8 5 ge 8XW 18 Zacas28 Se 1 2 8 15 8 6 ICO OO 8 15 8 6 1 ICO ee 8
99. CCO CCO CCO ICO CCO
100. 7 2 CCO 4 a FT TH 1 rms 2 CCO 7 2 CCO 1 CCO Edwards CCO 2 CCO mn 7 3 7 3 SvO2 Edwards Lifesciences 7 3 3 Edwards CCO
101. 1 IPX1 5 W USB oe 16 j ETL a GD ve 3 EU 9 ECIREP 18 1 8 COM 1 9 gt 2 2 19 CE EC Directive 20 CC No 93 422 EEC a 2002 96 EC Annex I I Edwards Lifesciences 2 9 2 4
102. 5 5 1 5 5 5 9 EDW 300 80 4 300 80 5 9 5 5 1 1 1
103. CCO CCO ICO 5 9 13
104. ee 10 15 10 11 2 DR RS SE SE RE 10 16 10 11 3 Vi EE SEE EE 10 17 10 11 4 ISSN ahaseSSSAESES1Yai8aPatSissiSie2ia 10 18 10 11 5 Sa 10 18 10 11 5 1 10 18 10 11 5 2 Sea RR 10 18 10 11 5 3 SSiaeiSK88e28ig2S 9SaiateiSieiaieig ais 10 18 10 11 5 4 emrmrn mi 10 18 11 STAT 11 1 11 1 RE CR SCR SR p 11 2 11 2 SARE RR EEE SRR 11 2 11 3 PPP 11 4 11 3 1 a ER SE ES 11 4 11 3 2 EE SE RE RE EEE SES 11 4 11 3 3 PC COP 11 5 11 3 4 NS RR RS RR RR RS 11 6 11 4 STAT 11 7 11 5 SE SE EE ER ER RS 11 8 11 5 1 11 8 11 5 2 Ha0858 Sie Sta1Saiieaie 358g82S5878H8
105. 7 3 4 CCO e CCO CCO 2 SNR SN CCO SNR 60 e CCO STAT CCI STAT e ST e SNR CCO SN SNR 10 20 dB 7 4 CCO CCI CCO CCI e
106. 8 5 CO CI 1 60 30 8P 1 2 2 e COavg e Clavg Edwards Lifesciences 8 5 3 4 8 3 2 ICO 2
107. 14 Edwards Lifesciences 7 11 7 4 7 CCO CCI CCO CCI 14 7 4 7 1 e 31C gt 41 e e e CCO e e e e e e 1 0 L min e CCO CO e
108. 5 7 5 3 1 CCO SS EE SE 5 7 5 3 2 ICO RA SR 5 9 5 4 WB GREER SS OR EE SRO RA ST GRE 5 11 5 5 CCO RS RR SIS 5 11 5 5 1 er 5 13 5 5 1 1 NE OE CC SE RE 5 13 5 5 1 2 DE 5 13 5 5 1 3 5 14 5 5 1 4 DR aR EN RR ER a ed 5 14 5 6 ICO ER RES 5 15 5 7 BT 5 16 5 8 IT ICO RN ORR RE ER RR EE RIS SG GGG RE 5 16 5 9 oe 5 16 5 9 1 1 5 9 2 ee 5 18 5 10 RR RE RR RRR RE 5 19 5 11 teetereeeeeeeeeree ee 5 19 5 12 5 21 5 12 1 ee 5 21 5122 STAT BOX emo 5 21 5 12 3 EE RR
109. CCO ICO b CO CI 2 3 8 5 CO 6 CO CI
110. 4 3 4 2 Edwards Lifesciences 4 3 TTF 4 3 4 7
111. si 8 10 6 ES NERS RI ER ER 8 10 2 inouetntteeenieeweis 8 11 3 T7207 7 0 8 13 2 8 13 EE RR EE EE ER ET 8 15 ET OL EI SE 8 16 CO SEER TC EES 8 16 ICO ea EE NR RS SIE SES 8 17 1 ti 8 18 2 SR RR ERR RRS TDR ER SS SEER 8 18 8 Eee2513SS72eeiSiSESRTe3828805SiS18De 23 ae 8 18 EDV omment 9 2 CCO 9 3 SvO 2 SS 9 4 ECG ee 9 4 a RR CS 9 7
112. teeter 2 8 2 4 Dain RE ER GI EES GRR ERT RR REE i EA 2 10 2 5 RE ER SE ER TEE ES 2 11 SEER GR IO RE RR RR RR RR NR RRR 3 1 3 1 RANE TEE EE SE CRD RES CEE 3 2 3 2 ER a VE RRR GE RR GR GIGI GG a GRE ERIE SSS GI ER SI TE a EE 3 2 3 3 P00047 PPT 0 TPT 70 3 2 4 1 4 1 STE EEE SE ENCE ER EEE ER 4 2 4 2 SS NE EE ER ER EES 4 2 4 3 SR ER EE RR EE EE i Ea ai 4 2 4 4 RE ES EEE SR ENS CEE ERE EE SEER 4 2 4 5 4 3 4 6 Da ER ER SE RE Ei EERE aa 4 3 4 7 SR EE RNC RR 4 4 4 8 EEE EE EC EE RE SS ES 4 5 4 8 1 RIE EE EE RE EE 4 5 4 8 2 RR RRR ETRE EERSTE ER RE REESE ERE 4 5 Edwards Lifesciences VI 5 5 1 5 1 WEES REE ERE RSE EE REE SR 5 3 5 2 5 3 5 2 1 5 3 5 2 2 5 5 5 3
113. 3 CO CI 5 10 ICO 1 2 Edwards Lifesciences CO 1 6 0 6 1 6 2 6 3 6 4 6 5 5 11 ICO 3 5 7 BT BT BT BT BT 1 1 5 8 IT ICO IT
114. 9 8 Edwards Lifesciences 9 7 9 8 9 9 9 10 9 11 9 12 10 1 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 10 11 10 12 10 13 10 14 10 15 10 16 10 17 10 18 10 19 11 1 11 2 11 3 11 4 11 5 11 6 11 7 11 8 STAT BOX CPPPPPPPFT 9 8 ET 9 9 CEDV ee 9 10 CEDV eee 9 10 CEDV SS 9 11 i ili 9 12 errr 10 2 10 3 10 4 10 4
115. STAT CCO CCI 60 1 STAT STAT BOX STAT STAT BOX STAT CCO CCI FY 19 lt 11 09 40 25 8 2005 7 6 STAT BOX 7 6 Edwards Lifesciences CCO CCO CCI STAT STAT STAT BOX CO
116. IEC EN 60601 1 1 2 1 OR AC CCO 2 POST POST BSA
117. 6 3 BSA 6 3 1 6 3 2 BSA 1 8 1 cm a 2 3 4
118. 1 32 32 BSA CI ICO ICO e ICO e
119. 5 13 3 ICO ICO ICO 8 ICO 5 14 1 2 14 5 22 Edwards Lifesciences 5 15 5 151 5 15 2 CO CO
120. 2 5 5 1 2 1 2 3 Edwards Lifesciences 5 13 e
121. 5 12 3 CCO 2 7 CCO 5 12 4 1 11 STAT 5 12 5 CO CI 8 ICO Edwards Lifesciences 5 21 5 13 CCO
122. RN RE RE SE 9 11 5 7 STAT ONAN 11 7 ee 11 9 NN RS RIE 11 9 11 10 Edwards Lifesciences Xili 11 9 11 10 11 11 11 12 11 13 12 1 13 1 14 1 14 2 1 1 4 1 5 1 5 2 5 3 5 4 5 5 5 6 6 1 6 2 11 1 11 2 11 3 12 1 12 2 12 3 13 1 XIV ere 11 12 ects 11 13 ee 1t 13 ee 11 14 11 15 12 2 13 2 CCO
123. ee 5 10 ee 5 12 YI A ER 5 20 Edwards Lifesciences 5 1 5 2 5 2 1 Edwar Lifesciences 6 mm 3 Na 2 5 1 5 1 5 1 Edwards Lifesciences 5 3 5 1
124. 3 6 a 6 CO CTI 8 11 3 6 CO CI CO CI 1 6 3 3 0 2 6 3 3 0 4 6 3 3 0 5 6 3 3 0 8 11 2 Edwards Lifesciences
125. BSA 1 20 cm __ kg 1 20 m BSA 1 20m2 6 4 6 4 1 6 5 24 6 5 Edwards Lifesciences 6 4 2
126. CO 5 12 1 6 5 12 2 STAT BOX STAT BOX CCO 8 STAT CCO CCI EDV EDVI RVEF STAT BOX 7 CCO 9 CEDV
127. ee 14 11 CCO 14 12 See Si 1 4 4 3 ee 5 4 5 6 CCO A S66 Ri de 5 8 CO 5 10 eee 5 12 VEITI NA ee 5 20 ee 6 3 6 6 9 ee 11 2 mem 11 11 mio 12 5 12 8 ECG oo 12 12 IFM Oo 13 3 Edwards Lifesciences 11 1 2 1 3 1 4 1 5 1 6 1 1 1 1 1 RS SD 1 2 4 11 CCO eesti doe 1 2 1 1 2 ICO enceseeessereseeretesessteseeeeeeertteterearee 1 2 1 1 3 CEDV P
128. 4 SQI 5 8 o gt e e M 6 1 5 5 7 Edwards Lifesciences 5 1 1 5 8 SvO2 5 5 5 5
129. meteerereeeeereeeeeeeeeeeeeeeeeeeeeeeeeee 14 1 14 1 14 2 14 2 14 2 14 2 1 OOO 0UIO 0 0 ee ev 14 2 14 2 2 SVR SVRI em 14 5 14 2 3 14 6 14 2 4 CEDV ee 14 8 14 2 5 _ ICO mmm 14 9 14 3 ee 14 11 14 4 CCO 14 11 Edwards Lifesciences 1 1 2 1 2 2 3 1 3 2 4 1 4 2 4 3 4 4 4 5 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 5 11 5 12 5 13 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 6 9 6 10 6 11 7 1 7 2 1 3 oe 2 8 ee 2 9 3 3
130. 4 24 08 2005 5 6 7 12 8 9
131. CO CT 2 3 8 5 c 6 CO CI 8 d CO CI
132. Vigilance Vigilance il dvards Lifesciences IN EE i Edwards Lifesciences 1 5 146 414 5 305 760 5 553 622 5 634 470 5 701 908 5 755 670 5 588 438 5 687 733 5 720 293 6 045 512 6 371 923 Edwards Lifesciences E Co set Edwards Vigilancell Edwards Li
133. 5 13 Edwards Lifesciences 5 6 ERATE CCO 6 12 13 CCO CEDV CO 5 O 1 CCO
134. 8 1 CO PA Stewart Hamilton L min BSA L min m 8 1 1 6 COavg 1 ICO
135. CCO CCO 6 CCO CCO CCO CCO 14 CCO 20 CCO CCO CCO CO
136. e e e e 8 6 6 3 e CCO CO Edwards Lifesciences 8 19 8 20 Edwards Lifesciences
137. Da RE Rs 6 6 642 O RN Snortisiisisdasindisiriiiosiaentian 6 7 6 4 3 SE EE 6 7 6 4 4 SSS SR RN RR 6 8 6 5 RR EE SCENE SE ES ENE 6 9 6 6 Su ER RR REE SR RE ER SI a 6 10 6 7 ee 6 11 6 7 1 Sa aE SEE SR Ei RE GE ES Sai 6 11 6 7 2 etter 6 12 6 7 3 6 14 6 7 4 SEER RE RR EE RE RRR ER 6 15 CCO ERE EE ER EE CE a a i tai 7 1 7 1 RR EE RRR ERE EE 7 2 7 2 SE RS TEE EE EE SR ES 7 3 7 3 CCO a ee 7 4 7 3 1 ss 7 4 7 3 2 CCO ee 7 5 7 3 3 CCO STAT BOX To 7 6 7 3 4 CCO a Si 7 7 7 4 _ CCO CCIF ee 7 7 7 4 1 CCO rrr 7 8 7 4 2 FPP 7 10 7 4 3 Sa 7 11 7 4 4 Sa dei RR RE RE RR RE ER 7 11 7 4 5 ICO RR RE TEER 7 11 7 46 CCO
138. Edwards Lifesciences 6 9 6 6 65 dB 3 3 4 EE C 65 dB al 5 6 7 3 6
139. SER EE EE 9 11 9 4 4 RS RR SRR 9 12 9 4 5 CCO 8 9 12 9 4 6 CEDV ENO ES RE RC EE TT RE 9 12 9 4 6 1 RR NE ER EE 9 12 9 4 6 2 RRS RR RR 9 12 Edwards Lifesciences 10 ER 8G RE RG RRR RR RR RR RR RR RR RE ini 10 1 10 1 Ei ERR EE RE SE a i a a 10 2 10 2 RRR EE RE ERE RE i Ri 10 2 10 2 1 ttre 10 2 10 3 SE RE REE RR EER REE 10 3 10 3 1 DS SER TE IE 10 3 10 3 2 a SE a ES 10 6 10 3 3 10 7 10 4 CR RE RS EN 10 7 10 5 OM RR RR 10 11 10 6 HGB Sa 10 12 10 7 ete 10 13 10 8 10 14 10 9 ER 10 14 10 10 SQI ee 10 14 10 11 10 15 10 11 1
140. e e e 2
141. A b A e X 6 1 3 3 lt XX 6 1 5 5 1 3
142. Edwards Lifesciences 6 15 STAT BOX 1 2 3
143. ICO CCO CCO CCO CCO CCO 7 CCO 8 ICO 5 15 3 CCO ICO CCO ICO ICO CCO CCO CCO 5 15 4 5 15 5
144. Edwards Lifesciences Edwards Lifesciences gt CCO CCO
145. 14 Edwards Lifesciences 5 2 2 52 Edwards Lifesciences 0 UN SN VG000000 5 REF VIG2 P N 692515 001 Vigilance Monitor Moniteur Vig jace Vigilance Monitor Monitor Vigilance Monitor Vigilance Il Wm Vigilance monitor Vigllance monitor Vigilance monitor Monitor Vigilance Vigilance 1 a ER T1AL 250V Vigilance Rx only Edwards Lifesciences LLC Irvine CA 92614 5686 USA Made in USA Bkomende palenten ziin eveneens aangevraagd og 6 US Patent No Brevet US N USA PalenNr Patents EEUULN Bceveti USA n VS patentnummer USA patent nt USApatent nr Patente dos EUA No 3 4507 974 4 651 741 5 146 414 5 305 760 5 553 622 5 588 438 5 634 470 5 687 733 5 701 908 5 720 293 5 755 670 6 045 512 and COrresponding foreign patents Uikewise a0dional palenls pendin
146. CO 0 6 0 0 0 15 30 45 ICO CO 8 7 2 3 2 3 Edwards Lifesciences coavg Clavg 13 25 32 25 8 2005 Esw 8 7 ICO 6 3
147. 2 e e STAT ICO e ICO e 5 13 1 4 11 STAT 5 13 2 STAT STAT STAT BOX 60 CCO CCI STAT EDV EDVI STAT RVEF STAT STAT 11 STAT
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184. fesciences Corporation Edwards Lifesciences Flexport PCMS SpaceLabs Inc 2006 Edwards Lifesciences LLC All rights reserved IEC REP Edwards Lifesciences Service GmbH Edisonstrasse 6 85716 Unterschleissheim Germany 2006 6 2 21700BZY00257 21 JMDN 10615010 2 Edwards Lifesciences i 14 9 Na et 1
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