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Edwards Lifesciences ( 1 4,651,741 Edwards LifesciencesEdwards E VigileoFloTrac SAT-1 Edwards Lifesciences Corporation Edwards Lifesciences 2004-2005 Edwards Lifesciences LLC. All rights reserved. : ( ) :2005 8 1 :21700BZY00328000 : 2 : (JMDN :70050000) : Edwards Lifesciences ii

12 8 1 2 : 3 : 4 : 5 : 6 CO : 7 ( ) 8 : 9 : 10 : 11 : USB 12 : iii Edwards Lifesciences

A B C D E F G H Edwards Lifesciences iv

............................................................................... ii..................................................................... iii............................................................................. xi............................................................................ xiii 1 1.1...................................................... 1-2 1.2.......................................................... 1-2 1.2.1 APCO................................ 1-3 1.2.2 ScvO / SvO..................................... 1-3 1.3.................................... 1-4 1.4.................... 1-4 1.5.............................................. 1-5 1.6................................................ 1-5 2 2.1.......................................................... 2-2 2.2.......................................... 2-2 2.2.1................................................... 2-3 2.2.2............................................. 2-6 2.2.3................................................... 2-7 2.3............................. 2-10 2.3.1.................................. 2-11 2.3.2.................................. 2-12 2.4............................. 2-15 2.5................................... 2-16 2.6..................................................... 2-17 3 3.1.......................................................... 3-2 3.2.......................................................... 3-2 3.3.................................................... 3-2 3.3.1 BSA.................................. 3-3 3.4.................................. 3-4 3.5 CO............................................. 3-5 v Edwards Lifesciences

Vigileo Monitor Operator s Manual 3.5.1............................................ 3-7 4 4.1.......................................................... 4-2 4.2.......................................................... 4-2 4.3........................................................ 4-2 4.4................................................ 4-3 4.4.1.............................................. 4-3 4.5...................................... 4-4 4.6................................................ 4-4 4.7.......................... 4-5 4.8................................. 4-6 4.9...................................................... 4-7 4.9.1........................................ 4-7 4.10................................................... 4-9 5 5.1.......................................................... 5-3 5.2 5-3 5.2.1.............................. 5-4 5.2.2...................................... 5-5 5.3........................................ 5-6 5.4.............................................. 5-8 5.4.1.......................................... 5-8 5.4.2........................... 5-9 5.5 CO................................................. 5-10 5.6....................................... 5-11 5.7........................................... 5-11 5.8 /........................................... 5-12 5.8.1........................... 5-12 5.8.2................................. 5-13 5.8.3................................. 5-13 5.9............................................... 5-14 5.10.................................................... 5-15 5.10.1........................................ 5-15 5.10.2 /............................... 5-15 5.10.3.................. 5-16 5.10.4.................................. 5-17 Edwards Lifesciences vi

6 CO 6.1.......................................................... 6-2 6.2 CO................................................... 6-2 6.2.1 CO..................................... 6-3 6.3 CO................................................... 6-3 6.3.1 CO............................. 6-4 6.3.2............................................. 6-4 6.3.3............................................. 6-6 6.3.4 CO..................... 6-6 6.4........................................ 6-8 6.4.1.......................... 6-8 6.4.2............................................. 6-8 6.5..................................................... 6-10 7 7.1.......................................................... 7-3 7.2........................................ 7-3 7.3................ 7-3 7.3.1....................................... 7-4 7.3.2................... 7-4 7.4........................................ 7-5 7.4.1................... 7-5 7.5.................................................... 7-5 7.6........................................ 7-6 7.7........................................ 7-8 7.7.1............ 7-10 7.7.2.......................... 7-11 7.7.3................. 7-11 7.8....................................... 7-12 7.8.1 OM................................ 7-19 7.8.2 HGB................................. 7-21 7.8.3.................................. 7-24 7.8.4...................................... 7-25 7.9 (SQI)........................ 7-26 8 8.1.......................................................... 8-3 8.1.1.............................. 8-3 8.2............................................ 8-4 8.2.1............................................... 8-5 8.2.2..................................... 8-6 8.2.3..................... 8-8 vii Edwards Lifesciences

Vigileo Monitor Operator s Manual 8.2.4............................................ 8-8 8.2.5........................................ 8-9 8.2.6.......................................... 8-9 8.2.7............................... 8-10 8.2.8 /.................................... 8-10 8.2.9........................................... 8-10 8.2.10................ 8-12 8.2.11.................. 8-15 8.2.12.................. 8-19 8.2.13................ 8-20 8.2.14...................................... 8-21 8.2.15.......................... 8-22 9 9.1.......................................................... 9-2 9.1.1 [ ]........................... 9-2 9.2................................ 9-3 9.2.1.................................. 9-4 9.2.2.................................. 9-4 10 10.1........................................................ 10-2 10.2........................................ 10-2 10.3.............................................. 10-2 10.3.1.......................... 10-4 10.3.2.............................. 10-5 10.3.3............................ 10-6 10.4............................................ 10-8 10.5................................................ 10-9 10.5.1............................. 10-10 10.6................................................. 10-11 10.6.1............................... 10-12 10.6.2................................. 10-13 10.6.3......................... 10-14 11 11.1........................................................ 11-2 11.2 USB....................................... 11-2 11.3............................................. 11-2 Edwards Lifesciences viii

12 12.1........................................................ 12-2 12.2.............................................. 12-2 12.3 CO/CI.................... 12-3 12.4......... 12-5 12.5 SVR/SVRI.............. 12-8 A A.1......................................................... A-2 A.2....................................... A-2 A.3................................................... A-4 A.4....................................................... A-5 B B.1..........................................................B-2 C C.1.............................................C-2 C.2.................................................C-2 C.3....................................C-2 D D.1........................................... D-2 D.2............................................... D-2 D.3 mmhg kpa................................................. D-2 D.4 dn-s/cm kpa-s/l............................................ D-3 D.5 g/dl mmol/l................................................ D-3 E E.1..........................................................E-2 E.2................................................E-2 E.3........................................E-3 E.4 /..............................E-3 E.4.1..................................E-4 E.4.2....................E-4 E.5..................................E-4 E.6............................................E-4 E.7 Edwards Lifesciences....................................E-5 E.8................................................E-6 E.9..............................................E-6 ix Edwards Lifesciences

Vigileo Monitor Operator s Manual E.10......................................................... E-6 F F.1.................................................... F-2 F.2.................................................. F-2 G Edwards Lifesciences x

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

7-16 OM.............................. 7-20 7-17 OM.............................. 7-21 7-18 HGB............................... 7-22 7-19.............. 7-23 7-20.............. 7-24 7-21............ 7-25 8-1..... 8-3 8-2......................... 8-3 8-3................................... 8-4 8-4......................... 8-5 8-5................................... 8-6 8-6................... 8-8 8-7.................................. 8-11 8-8.................................. 8-13 8-9................ 8-16 8-10 -................................................... 8-17 8-11 -................................................... 8-18 8-12.................... 8-19 8-13........ 8-20 8-14.............................. 8-21 9-1 / 9-2 9-2 /.................................... 9-2 9-3................................... 9-3 10-1.......................................... 10-2 10-2............................ 10-3 10-3.......................... 10-4 10-4........................ 10-6 10-5................ 10-7 10-6................................ 10-8 10-7........................................ 10-9 10-8................................... 10-10 10-9............................... 10-11 10-10......................... 10-12 10-11................................. 10-13 E-1............................. E-5

1-1................................ 1-5 2-1.................................................. 2-3 2-2............................................ 2-6 2-3.................................................. 2-7 2-4................................. 2-11 2-5................................. 2-13 2-6..................... 2-15 2-7........................... 2-16 2-8............................................. 2-17 4-1.......................... 4-2 4-2.............................................. 4-3 5-1................................ 5-4 5-2.............................. 5-5 5-3.......................... 5-7 6-1.................................. 6-6 6-2...................... 6-7 7-1........ 7-7 7-2...................... 7-9 7-3.............. 7-17 7-4............... 7-26 8-1.......................... 8-5 8-2.......................... 8-7 8-3.............. 8-13 8-4................................. 8-16 10-1......................... 10-5 10-2......................................... 10-9 10-3............................ 10-13 10-4.................................. 10-14 12-1 CO/CI..................................... 12-3 12-2 CO/CI........................................... 12-4 12-3 CO/CI............... 12-4 12-4............................. 12-5 12-5................................... 12-6

12-6...... 12-7 12-7 SVR/SVRI....................................... 12-8 12-8 SVR/SVRI........... 12-8 A-1............................... A-2 A-3........................................... A-3 A-2....................................... A-3 A-4....................................... A-4 A-5....................................... A-4 A-6..................................... A-4 A-7............................... A-5 B-1............................... B-3 C-1............................... C-2 C-2............................... C-2 C-3....................................... C-2 C-4....................................... C-2 C-5........................... C-2 F-1......................................... F-2 F-2.................................. F-3 F-3 ( RF RF)....................... F-4 F-5..... F-5 F-4 RF............................................... F-5

1 1.1...................................................... 1-2 1.2.......................................................... 1-2 1.2.1 APCO................................ 1-3 1.2.2 ScvO / SvO......................... 1-3 1.3.................................... 1-4 1.4.................... 1-4 1.5.............................................. 1-5 1.6................................................ 1-5 1-1.......... 1-2 1-2................... 1-4 1-1................................ 1-5

Vigileo 1.1 1.2 APCO ScvO SvO SV 1 SVV 1 SVR APCO IEC 60601-1-1 1-1 Edwards Lifesciences 1-2

Vigileo 1.2.1 APCO 1 1 1.2.2 ScvO / SvO LED ScvO /SvO 1-3 Edwards Lifesciences

Vigileo 1.3 Edwards Lifesciences 1.4 1-2 Edwards Lifesciences 1-4

Vigileo 1.5 1-1 APCO PAC BP POST BSA PR CI ScvO 2 CO SQI CVC SV 1 CVP SVI 1 EO SvO 2 Hct SVR HGB SVRI NVRAM SVV 1 1.6 / / 2 2 1-5 Edwards Lifesciences

Vigileo Edwards Lifesciences 1-6

2 2.1.......................................................... 2-2 2.2.......................................... 2-2 2.2.1................................................... 2-3 2.2.2............................................. 2-6 2.2.3................................................... 2-7 2.3............................. 2-10 2.3.1.................................. 2-11 2.3.2.................................. 2-12 2.4............................. 2-15 2.5................................... 2-16 2.6..................................................... 2-17 2-1................................... 2-11 2-2................................. 2-12 2-1.................................................. 2-3 2-2............................................ 2-6 2-3.................................................. 2-7 2-4................................. 2-11 2-5................................. 2-13 2-6..................... 2-15 2-7........................... 2-16 2-8............................................. 2-17

Vigileo 2.1 2.2 Edwards Lifesciences 2-2

2.2.1 2-1 1 1 2 3 4 3 4 4 4 2-3 Edwards Lifesciences

Vigileo 4 4 7 4 6 5 6 7 E E F 2-1 F Edwards Lifesciences 2-4

1 4 6 4 4 F 4 ( ) 4 7 4 4 8 2-1 [ ] 8 2-5 Edwards Lifesciences

Vigileo 8 (ITE) IEC/EN 60950 1.5 ITE II 11 2-1 A E 2.2.2 2-2 4 4 Edwards Lifesciences 2-6

2.2.3 2-3 / * * 3 3 4 3 7 3 7 MRI MRI 4 4 2-7 Edwards Lifesciences

Vigileo 4 4 4 4 4 4 6 6 2-3 7 Edwards Lifesciences 2-8

SQI AC 7 CVP SVR CVP 8 2-3 8 4 E E E 2-9 Edwards Lifesciences

Vigileo E EO E NaCl E E E 2-3 E 2.3 2-1 2-2 Edwards Lifesciences 2-10

2.3.1 2-1 2-4 1 Edwards Lifesciences 2 3 4 AC AC / / / 3 3 1 5 6 / 7 2-11 Edwards Lifesciences

Vigileo 2-4 8 9 10 2.3.2 2-2 Edwards Lifesciences 2-12

2-5 1 2 B 3 : 4 : 5 : 6 :USB 7 : COM 8 9 : ( ) CF F ( ) 10 11 : : 12 13 ETL 14 : ( ) 15 Edwards Lifesciences 16 2-13 Edwards Lifesciences

Vigileo 2-5 17 18 : 19 EU 20 21 22 CE : EC No.93/42/ EEC Annex II Edwards Lifesciences 2-14

2.4 2-6 CO/CI ScvO 2 SvO 2 : 2 : SQI 1 2 3 4 / / / 2-15 Edwards Lifesciences

Vigileo 2.5 2-7 95 10 70 C -25 C Edwards Lifesciences 2-16

2.6 F 2-8 EN60601-1:1990/A1:1993/A2:1995/A13:1996 EN60601-1:1990/A1:2003/A2:1995/A13:1996 EN60601-1-1:1990/A1:2003/A2:1995/A13:1996 EN60601-1-2:2001 EN60601-1-4:1996:2003/A2:1995/A13:1996 EN60601-2-49:2001 EN60601-1-2:2001 UL 60601-1:2003 CAN/CSA C22.2 No. 606.1-M90 (R2001) EN60529 1991/A1:2000 I B CF B I B CF I B CF IPX1 EN 60601-1-1 2-17 Edwards Lifesciences

Vigileo Edwards Lifesciences 2-18

3 3.1.......................................................... 3-2 3.2.......................................................... 3-2 3.3.................................................... 3-2 3.3.1 BSA.................................. 3-3 3.4.................................. 3-4 3.5 CO............................................. 3-5 3.5.1 3-7 3-1.................................. 3-3 3-2................................ 3-4 3-3 CO.......................................... 3-6

Vigileo 3.1 3.2 IEC/EN 60950 IEC/EN 60601-1 IEC/EN 60601-1-1 2 3.3 1. AC AC 2. POST Edwards Lifesciences 3-2

3.3.1 BSA POST BSA 3-1 1. 2. [ ] CO 1 CO 3-3 Edwards Lifesciences

Vigileo 3.4 1. 20 2. 3. 3-2 4. [ ] 5. Edwards Lifesciences 3-4

3.5 CO 6. [ ] HGB Hct [ ] 7. HGB Hct 8. [ ] 20 OK [ ] 9. [ ] 1. 2. 3. 4. CO 5. CO [ ] 3-5 Edwards Lifesciences

Vigileo 3-3 CO 6. [CO] [CI] / * * Edwards Lifesciences 3-6

3.5.1 1. CO CO 2. 0 3. [ ] 4. [ ] CO 3-7 Edwards Lifesciences

Vigileo Edwards Lifesciences 3-8

4 4.1.......................................................... 4-2 4.2.......................................................... 4-2 4.3........................................................ 4-2 4.4................................................ 4-3 4.4.1............................................... 4-3 4.5...................................... 4-4 4.6................................................ 4-4 4.7.......................... 4-5 4.8.................................. 4-6 4.9...................................................... 4-7 4.9.1......................................... 4-7 4.10................................................... 4-9 4-1.............................. 4-8 4-2.......................................... 4-9 4-1.......................... 4-2 4-2.............................................. 4-3

Vigileo 4.1 POST 4.2 4.3 4-1 CO SVR SV Edwards Edwards Lifesciences 4-2

4.4 4.4.1 4-2 0 50 10 37-25 70 10% 95% 696 1013 hpa ( ) 4-3 Edwards Lifesciences

Vigileo MRI MRI ( ) 4.5 4.6 100 ~ 240 VAC Edwards Lifesciences 4-4

A 4.7 1. 20 2. 4-5 Edwards Lifesciences

Vigileo 4.8 1. 2. 3. Edwards Lifesciences 4-6

4.9 POST POST 4.9.1 1. / 2. POST 3. 4-1 4. 5 4-7 Edwards Lifesciences

Vigileo 4-1 POST 12 E Edwards Lifesciences 4-8

4.10 POST English (US) 1. 2. English (US) 12 ; / / English (UK)FrançaisDeutschItalianoEspañol 4-2 4-9 Edwards Lifesciences

Vigileo 24 ;.. 6 CO Edwards Lifesciences 4-10

5 5.1.......................................................... 5-3 5.2 5-3 5.2.1............................... 5-4 5.2.2....................................... 5-5 5.3........................................ 5-6 5.4.............................................. 5-8 5.4.1........................................... 5-8 5.4.2............................ 5-9 5.5 CO.................................................. 5-10 5.6....................................... 5-11 5.7........................................... 5-11 5.8 /............................................ 5-12 5.8.1............................ 5-12 5.8.2.................................. 5-13 5.8.3.................................. 5-13 5.9............................................... 5-14 5.10.................................................... 5-15 5.10.1......................................... 5-15 5.10.2 /............................... 5-15 5.10.3................... 5-16 5.10.4................................... 5-17

Vigileo 5-1............................. 5-3 5-2............................... 5-6 5-3................................... 5-8 5-4. 5-9 5-5 CO......................................... 5-10 5-6 CO................ 5-10 5-7.............................. 5-11 5-8...... 5-11 5-9 CO............................ 5-11 5-10 /................................... 5-12 5-11.................................. 5-12 5-12.......................................... 5-14 5-13...................... 5-17 5-1 5-4 5-2............................. 5-5 5-3......................... 5-7 Edwards Lifesciences 5-2

5.1 / 6 10 5.2 5 5-1 5-3 Edwards Lifesciences

Vigileo 5-1 1 2 3 4 Edwards Lifesciences AC : AC / / / 3 3 1 5 6 / 7 8 9 10 5.2.1 / 1. 2. 3. Edwards Lifesciences 5-4

5.2.2 5-2 / / / / AC AC 3 3 1 / / 5-5 Edwards Lifesciences

Vigileo 5.3 2 5-2 Edwards Lifesciences 5-6

5-3 1 2 B 3 : 4 : 5 6 USB 7 : COM 8 ( ) 9 CF F ( ) 10 :f 5-7 Edwards Lifesciences

Vigileo 5.4 5.4.1 5-3 2 Edwards Lifesciences 5-8

5-4 5.4.2 5-9 Edwards Lifesciences

Vigileo 5.5 CO CO CO/CI 5-5 CO CO CO CI / 5-6 CO CO CO CO Edwards Lifesciences 5-10

5.6 ScvO /SvO ScvO SvO (SQI) 5-7 5.7 5-8 CO 1 CO 2 5-9 CO 5-11 Edwards Lifesciences

Vigileo 5.8 / / / [ ] 5-10 / 5.8.1 [ ] 1. / 2. [ ] 5-11 3. [ ] 4. 5. Edwards Lifesciences 5-12

6. [ ] / 7. [ ] 8. 12/4/2006 [ / / ] 4.12.2006 [.. ] 9. 10. 5.8.2 1. [ ] 2. 3. 4. 3 5. [ ] / 5.8.3 1. [ ] 2. 3. 2 12 4. [ ] / 5-13 Edwards Lifesciences

Vigileo 5.9 3 1 3 2 5-12 Edwards Lifesciences 5-14

5.10 5.10.1 CO CI / CO 5.10.2 / CO / 5-15 Edwards Lifesciences

Vigileo 5.10.3 2 CO / 1 1 Edwards Lifesciences 5-16

5.10.4 [ ] / [ ] 2 1. CO 2. [ ] 5-13 3. 4. 5. [ ] 5-17 Edwards Lifesciences

Vigileo Edwards Lifesciences 5-18

Vigileo 6.1 CO CO CO CO 20 CO / L/minCI / / L/min/ m 6.2 CO CO 6-1 CO 6-2 CO Edwards Lifesciences 6-2

CO 6.2.1 CO 1. CO 6-3 CO 2. CO 6.3 CO CO CO 6-3 Edwards Lifesciences

Vigileo 6.3.1 CO 1. 2. 6.3.2 6-4 CO CO [ ] 2 BSA CO CO Edwards Lifesciences 6-4

CO 6-5 1. [ ] 2. 3. 4. [ ] CO 6-5 Edwards Lifesciences

Vigileo 6-1 CO M M F 2 ~ 120 1 50 2 ~ 880 1 1.0 ~ 400.0 0.5 12 ~ 98 1 30 ~ 250 1 150 68.0 60 152 BSA 0.08 ~ 5.02 m 0.01 m 1.65 m 6.3.3 [ ] CO CI 1. [ ] 2. [CO] [CI] 3. 6.3.4 CO [ ] CO/CI CO CO/CI / [ ] CO 2 Edwards Lifesciences 6-6

CO 6-6 CO 1. 2. 3. [ ] CO 6-2 CO ( ) CO CI CO/CI 4.0 ~ 20.0 1.0 CO/CI 0.0 ~ 10.0 1.0 CO CI CO 2.0 ~ 20.0 0.1 CI 1.0 ~ 20.0 0.1 CO 1.0 ~ 19.0 0.1 CI 0.0 ~ 19.0 0.1 6-7 Edwards Lifesciences

Vigileo 6.4 6.4.1 1. 2. / 3. 4. 5. 6.4.2 [ ] [ ] CO / BSA CO CO Edwards Lifesciences 6-8

CO 1. 2. 0 3. 0 [ ] 6-7 6-9 Edwards Lifesciences

Vigileo 6.5 [ ] [ ] [ ] 6-8 10 ± 50 mmhg 10 PR BP PR BP 20 ----- Edwards Lifesciences 6-10

7 7.1.......................................................... 7-3 7.2........................................ 7-3 7.3................ 7-3 7.3.1....................................... 7-4 7.3.2................... 7-4 7.4........................................ 7-5 7.4.1................... 7-5 7.5.................................................... 7-5 7.6........................................ 7-6 7.7........................................ 7-8 7.7.1............ 7-10 7.7.2.......................... 7-11 7.7.3................. 7-11 7.8....................................... 7-12 7.8.1 OM................................ 7-19 7.8.2 HGB................................. 7-21 7.8.3.................................. 7-24 7.8.4...................................... 7-25 7.9 (SQI)........................ 7-26

Vigileo 7-1............................... 7-3 7-2....... 7-3 7-3............................................ 7-4 7-4............................... 7-5 7-5............. 7-6 7-6. 7-8 7-7........... 7-9 7-8 OK............. 7-10 7-9.......... 7-11 7-10................ 7-13 7-11 7-14 7-12.. 7-15 7-13........ 7-16 7-14.... 7-17 7-15.................... 7-18 7-16 OM.............................. 7-20 7-17 OM.............................. 7-21 7-18 HGB............................... 7-22 7-19.............. 7-23 7-20.............. 7-24 7-21............ 7-25 7-1....... 7-7 7-2..................... 7-9 7-3.............. 7-17 7-4.............. 7-26 Edwards Lifesciences 7-2

7.1 Edwards 7.2 ScvO 2 SvO SQI 7-1 7-2 7.3 7-3 Edwards Lifesciences

Vigileo 7.3.1 Edwards 1. 2. TOP 3. - 7.3.2 1. 7-3 Edwards Lifesciences 7-4

7-4 7.4 7.5 2 7.4.1 1. 2. [ ] ScvO 2 SvO 2 1. [ ] 2. [ScvO 2 ] [SvO 2 ] 7-5 Edwards Lifesciences

Vigileo 7.6 / [ ] 2 1. 2. 7-5 Edwards Lifesciences 7-6

3. 4. 5. [ ] 7-1 20 ~ 100 10 0 ~ 60 10 20 ~ 99 1 0 ~ 60 1 7-7 Edwards Lifesciences

Vigileo 7.7 7-6 1. [ ] 2. HGB Hct 3 8 3. HGB [HGB] 4. HGB 5. Edwards Lifesciences 7-8

6. [Hct ] 7. Hct 8. 9. HGB 11.5 g/dl7.1 mmol/llhct 35% [ ] 10. 7-7 7-2 HGB g/dl HGB mmol/l HGB 4.0 ~ 20.0 0.1 2.5 ~ 12.4 0.1 Hct % Hct 12 ~ 60 1 7-9 Edwards Lifesciences

Vigileo 7.7.1 7-8 OK 1. [ ] xx xx 25 1 [ ] Edwards Lifesciences 7-10

7.7.2 7-9 1. [ ] 7.7.3 1. [ ] 7-11 Edwards Lifesciences

Vigileo 7.8 ( ) 24 Edwards Lifesciences 7-12

1. [ ] 7-10 7-13 Edwards Lifesciences

Vigileo 7-11 Edwards Lifesciences 7-14

7-12 1. 12 [ ] [ ] [ ] 7-15 Edwards Lifesciences

Vigileo 7-13 2. ScvO 2 /SvO 2 HGB Edwards Lifesciences 7-16

7-14 7-3 ScvO 2 SvO 2 HGB (g/dl) HGB mmol/l Hct % ScvO 2 /SvO 2 HGB Hct [ ] /HGB/Hct 10.0 ~ 99.0 0.1 4.0 ~ 20.0 0.1 2.5 ~ 12.4 0.1 12 ~ 60 1 3. 4. 30 2 mlcc 7-17 Edwards Lifesciences

Vigileo 5. 6. HGB Hct HGB Hct HGB Hct 7. [ ] 7-15 25 Edwards Lifesciences 7-18

7.8.1 OM ( BSA ) 1. SAT-1 Edwards 2. 3. 4. 5. 6. [OM ] 7. 7-19 Edwards Lifesciences

Vigileo 7-16 OM 8. 24 / [ ] [ ] 24 24 Edwards Lifesciences 7-20

9. [ ] [ ] 10. CO 7.8.2 HGB 7-17 OM 10 1. 2. [ HGB ] 7-21 Edwards Lifesciences

Vigileo 7-18 HGB 3. 4. HGB HGB 5. HGB 6. HGB 7. Hct 8. Hct Hct 9. Hct 10. HGB 11. [ ] Edwards Lifesciences 7-22

Hct 6% HGB 1.8 g/dl(1.1 mmol/l) HGB Hct SQI HGB 7-19 12. HGB [ ] HGB Hct HGB 7-23 Edwards Lifesciences

Vigileo 7.8.3 SQI 12 SQI 1. 2. [ ] 7-20 Edwards Lifesciences 7-24

7.8.4 1. 2. [ ] 3. [ ] 7-21 [ ] 4. 7-25 Edwards Lifesciences

Vigileo 7.9 (SQI) SQI SQI SQI 2 1 4 7-4 1 2 3 4 1 ( ) ( ) HGB SQI 1 2 SQI 3 4 12 SQI AC Edwards Lifesciences 7-26

8 8.1.......................................................... 8-3 8.1.1.............................. 8-3 8.2............................................ 8-4 8.2.1............................................... 8-5 8.2.2..................................... 8-6 8.2.3..................... 8-8 8.2.4............................................. 8-8 8.2.5......................................... 8-9 8.2.6........................................... 8-9 8.2.7................................ 8-10 8.2.8 /.................................... 8-10 8.2.9............................................ 8-10 8.2.10................. 8-12 8.2.11................... 8-15 8.2.12................... 8-19 8.2.13................ 8-20 8.2.14....................................... 8-21 8.2.15........................... 8-22

Vigileo 8-1..... 8-3 8-2......................... 8-3 8-3................................... 8-4 8-4......................... 8-5 8-5................................... 8-6 8-6................... 8-8 8-7.................................. 8-11 8-8.................................. 8-13 8-9................ 8-16 8-10 -................................................... 8-17 8-11 -................................................... 8-18 8-12.................... 8-19 8-13........ 8-20 8-14.............................. 8-21 8-1......................... 8-5 8-2......................... 8-7 8-3.............. 8-13 8-4................................ 8-16 Edwards Lifesciences 8-2

8.1 CO 1 CO 8.1.1 1. 8-1 8-2 8-3 Edwards Lifesciences

Vigileo 8.2 2 8-3 1. 2. 3. [ ] Edwards Lifesciences 8-4

8-1 CO/CI ScvO 2 /SvO 2 8.2.1 [ ] 8-4 1. [ ] CO/CI 2. [ ] [ ] 8-5 Edwards Lifesciences

Vigileo 8.2.2 [ ] [ ] 2 1. 2. [ ] 8-5 3. 4. 5. [ ] Edwards Lifesciences 8-6

8-2 M F M ( ) F ( ) 2 ~ 120 1 2 ~ 880 1 1.0 ~ 400.0 0.5 12 ~ 98 1 30 ~ 250 1 BSA 0.08 ~ 5.02 m 0.01 m BSA 8-7 Edwards Lifesciences

Vigileo 8.2.3 / 8.2.4 1. 2. [ ] 3. [ ] 4. 5. English (US) 8-6 Edwards Lifesciences 8-8

12 / / English (UK)FrançaisDeutschItalianoEspañol 24.. 8.2.5 1. 2. [ ] 3. [ ] 4. 5. 8.2.6 1. 2. [ ] 3. [ ] 4. 5. 8-9 Edwards Lifesciences

Vigileo 8.2.7 [ ] 8.2.8 / [ / ] 1. 2. [ ] 3. [ / ] 4. 8.2.9 1. 2. 3. [ ] Edwards Lifesciences 8-10

4. [ ] 5. 6. 8-7 [ ] 7. 2 CO 8-11 Edwards Lifesciences

Vigileo 8. 8.2.10 [ ] [ ] 2 1. 2. [ ] 3. 4. Edwards Lifesciences 8-12

5. [ ] 8-8 8-3 57600 1 8 8-13 Edwards Lifesciences

Vigileo 8-3 IFM 1200 2400 9600 19200 38400 57600 57600 1 2 7 8 2 10 20 60 IFMout 1200 2400 9600 19200 38400 57600 1 2 7 8 1 8 2 57600 1 8 12 72 24 48 72 9600 1 8 Edwards Lifesciences 8-14

8.2.11 [ ] [ ] 2 1. 2. [ ] 3. [ ] 4. [CVP ] 5. [ ] 6. 7. [ ] 8. CVP 80 100 mmhg10.7 to 13.3 kpa 8-15 Edwards Lifesciences

Vigileo 8-9 8-4 CVP 0 ~ 1 V 0 ~ 5 V 0 ~ 10 V 80 ~ 100 mmhg 1 mmhg 10.7 ~ 13.3 kpa 0.1 kpa 50 ~ 100 mmhg 1 mmhg 6.7 ~ 13.3 kpa 0.1 kpa 0 ~ 10 mmhg 1 mmhg 0.0 ~ 1.3 kpa 0.1 kpa 0 ~ 1 V 100 mmhg 13.3 kpa 100 mmhg 13.3 kpa 0 mmhg 0.0 kpa Edwards Lifesciences 8-16

[ ] [ ] [ ] 8-10 - [A/D ] A/D A/C A/D [ ] 8-17 Edwards Lifesciences

Vigileo 8-11 - [A/D ] A/D A/C A/D CVP SVR CVP ( ) ( ) Edwards Lifesciences 8-18

8.2.12 [ ] [ ] 2 1. 2. [ ] 8-12 3. [ ] 4. 10V 1 V 5. 6. [ ] 7. 8. [ ] [ ] 8-19 Edwards Lifesciences

Vigileo 8.2.13 [ ] 1. [ ] 1 V 10 V 2. [ ] 0 V 8-13 Edwards Lifesciences 8-20

8.2.14 [ ] [ ] 1. 2. [ ] 8-14 3. [ ] 4. / 5 8-21 Edwards Lifesciences

Vigileo 8.2.15 [ ] [ ] [ ] 1. 4 2. Edwards Lifesciences 8-22

9 9.1.......................................................... 9-2 9.1.1 [ ]............................ 9-2 9.2................................ 9-3 9.2.1................................... 9-4 9.2.2................................... 9-4 9-1 / 9-2 9-2 /.................................... 9-2 9-3.................................... 9-3

Vigileo 9.1 / [ ] CO 9.1.1 [ ] 1. / 9-1 / 9-2 / 2. [ ] Edwards Lifesciences 9-2

9.2 9-3 [ ] 2 1. / [ ] 2. [ ] 3. 4. 5. [ ] / 6. [ ] 7. 12/4/2003 [ / / ] 4.12.2003 [.. ] 8. 9. 9-3 Edwards Lifesciences

Vigileo 9.2.1 1. [ ] 2. 3. 4. 5. 3 4 6. [ ] / 9.2.2 1. [ ] 2. 3. 4. 5. 3 4 12 6. [ ] / Edwards Lifesciences 9-4

10 10.1........................................................ 10-2 10.2........................................ 10-2 10.3.............................................. 10-2 10.3.1........................... 10-4 10.3.2............................... 10-5 10.3.3............................. 10-6 10.4............................................ 10-8 10.5................................................ 10-9 10.5.1.............................. 10-10 10.6................................................. 10-11 10.6.1................................ 10-12 10.6.2.................................. 10-13 10.6.3.......................... 10-14 10-1........................................... 10-2 10-2............................. 10-3 10-3........................... 10-4 10-4......................... 10-6 10-5................. 10-7 10-6................................. 10-8 10-7......................................... 10-9 10-8.................................... 10-10 10-9................................ 10-11 10-10.......................... 10-12 10-11.................................. 10-13 10-1......................... 10-5 10-2......................................... 10-9 10-3............................ 10-13 10-4.................................. 10-14

Vigileo 10.1 CO 6 10.2 10.3 10-1 CO / [ ] CO Edwards Lifesciences 10-2

/ 10-2 T 10-3 Edwards Lifesciences

Vigileo 10.3.1 10-3 x1 x10x60 CO Edwards Lifesciences 10-4

1. 72 2. 3 3. 10.3.2 10-1 x1 1 x10 10 x60 60 1. 2. 10-5 Edwards Lifesciences

Vigileo 10-4 3. [ ] 4. 5. 6. [ ] 10.3.3 CO 1. CO 2. CO 3. Edwards Lifesciences 10-6

10-5 4. 5. 6. 7. 8. [ ] 10-7 Edwards Lifesciences

Vigileo 10.4 32 10-6 1. 2. [ ] 1. [ ] 2. 3. [ ] Edwards Lifesciences 10-8

10-2 HGB OM OM HGB OM 0 10.5 6 10-7 10-9 Edwards Lifesciences

Vigileo 10.5.1 2 1. 2. / SVI 10-8 3. 4. 5. [ ] Edwards Lifesciences 10-10

2 10.6 5 CO 3 / 10-9 10-11 Edwards Lifesciences

Vigileo 10.6.1 10-10 - - / 72 Edwards Lifesciences 10-12

3 10-3 x1 x 1 x8 x 8 x40 x 40 10.6.2 1. 2. 10-11 10-13 Edwards Lifesciences

Vigileo 3. [ ] 4. 5. [ ] 10-4 1 5 10 30 60 10.6.3 1. 2. [ ] 3. COSV SVR [ ] CISVI SVRI [ ] 4. 5. CO CI 2 Edwards Lifesciences 10-14

11 11.1........................................................ 11-2 11.2 USB....................................... 11-2 11.3.............................................. 11-2

Vigileo 11.1 USB IEC/EN 60950 1.5 11.2 USB 11.3 USB ITE II USB 1. USB 2. USB 3. 4. Edwards Lifesciences 11-2

Vigileo 12.1 12.2 Edwards Lifesciences 12-2

12.3 CO/CI 12-1 CO/CI FloTrac CO FloTrac FloTrac FloTrac Edwards FloTrac FloTrac Edwards Edwards Edwards Edwards 12-3 Edwards Lifesciences

Vigileo 12-2 CO/CI CO/CI CO FloTrac 12-3 CO/CI FloTrac CO/CI CI > CO BSA( ) BSA( ) 1 CO - CO 0 0 CO 0 ( BSA CO CO CO Edwards Lifesciences 12-4

12.4 12-4 OM /IR OM / / ScvO /SvO HGB Hct v HGB ScvO /SvO 0-99% / Edwards / 70% ScvO /SvO HGB Hct HGB ScvO /SvO 70% / 12-5 Edwards Lifesciences

Vigileo 12-5 SQI = 4 HGB/Hct X HGB/Hct / ScvO /SvO HGB/Hct X Edwards Lifesciences 12-6

12-6 / OM - OM 24-24 Edwards / Edwards / 12-7 Edwards Lifesciences

Vigileo 12.5 SVR/SVRI 12-7 SVR/SVRI SVR: 12-8 SVR/SVRI CO/CI SVR SVRI CVP BSA ( ) BSA( ) 1 Vigileo Vigileo / Vigileo Vigileo / (mmhg kpa) Edwards Lifesciences 12-8

A A.1......................................................... A-2 A.2....................................... A-2 A.3................................................... A-4 A.4....................................................... A-5 A-1............................... A-2 A-3........................................... A-3 A-2....................................... A-3 A-4....................................... A-4 A-5....................................... A-4 A-6..................................... A-4 A-7.............................. A-5

Vigileo A.1 (CO) (ScvO 2 / SvO ) A A.2 A-1 6 2.73 kg 7.3 inch 18.54 cm 10.7 inch 27.18 cm 8.4 inch 21.34 cm TFT 5.2 3.9 inch 132.5 mm 99.4 mm 640 480 Edwards Lifesciences A-2

A-2 0 50 10 37-25 70 10 95% 696 1013 hpa A-3 0 ~ 1V 0 ~ 5V 0 ~ 10V >100 k 1/8 = 5Hz 12 ±1 LSB 1 0 ~ 1V 0 ~ 10V = 10 Hz = 8 ; = ±2.5% = ±1% 1/8 2 RS232 = 57.6 kbps 6 1 5 USB V1.1 A 1 100 ~ 240 VAC 50/60 Hz 1 A( ) 1.0A 250 V ( ) 5 20 mm 2 A-3 Edwards Lifesciences

Vigileo A.3 A-4 CO 1 20 L/min ±6% 0.1 L/min 20 - A-5 ScvO /SvO 0 99% ±2% (30 ~ 99% ) 2 A-6 PR 20 Edwards Lifesciences A-4

A.4 A-7 Edwards * Edwards * * * * APCO9 OM2 OM2E USB ITE II USB 1.1 Edwards 70AN ** MHAPLMNT * CE ** Edwards Lifesciences Philips(Agilent) GE(Marquette) Spacelabs OSI Systems A-5 Edwards Lifesciences

Vigileo Edwards Lifesciences A-6

B B.1..........................................................B-2 B-1................................B-3

Vigileo B.1 2.4 CO 2.4492 CO = Edwards Lifesciences B-2

B-1 CI SVR SVRI SV SVI SVV CI = CO/BSA : CI - CO - L/min BSA - m L/min/m SVR = {(MAP - CVP) x 80} /CO (dyne-sec/cm ) SVR = {(MAP - CVP ) x 60} /CO (kpa-sec/l) : MAP - mmhg MAPSI - kpa CVP - mmhg CVP - kpa CO - L/min SVRI = {(MAP - CVP) x 80} /CI (dyne-sec-m /cm ) SVRI = {(MAP - CVP ) x 60} /CI (kpa-sec-m /L) : MAP - mmhg MAP - kpa CVP - mmhg CVP - kpa CI - L/min/m 1 SV = (CO/PR) x 1000 : CO - L/min PR - beats/min (ml/beat) 1 SV = (CI/PR) x 1000 (ml/beat/m ) : CI - L/min/m PR - beats/min 1 SVV = 100 x (SVmax - SVmin) / mean(sv) (%) 20 BSA Dubois BSA = 71.84 x (WT ) x (HT ) /10,000 (m ) : WT - kg HT - cm B-3 Edwards Lifesciences

Vigileo Edwards Lifesciences B-4

C C.1.............................................C-2 C.2.................................................C-2 C.3....................................C-2 C-1 C-2 C-3 C-4 C-5................................C-2................................C-2........................................C-2........................................C-2............................C-2

Vigileo C.1 C-1 20 ~ 100 10 100 % CO 4 ~ 20 1 12 L/min CI 1 ~ 20 1 12 L/min/m C-2 0 ~ 60 10 0 % CO 0 ~ 10 1 0 L/min CI 0 ~ 10 1 0 L/min/m C.2 C-3 20 ~ 99 1 99 % CO 2 ~ 20 0.1 14 L/min CI 1 ~ 20 0.1 7 L/min/m C-4 0 ~ 60 1 10 % CO 1 ~ 19 0.1 2 L/min CI 0 ~ 19 0.1 1 L/min/m C.3 C-5 1 1 COM 1 Edwards Lifesciences C-2

D D.1........................................... D-2 D.2............................................... D-2 D.3 mmhg kpa................................................. D-2 D.4 dn-s/cm kpa-s/l............................................ D-3 D.5 g/dl mmol/l................................................ D-3

Vigileo D.1 kg 2.2 kg kg 2.2 D.2 cm 2.54 cm cm 2.54 D.3 mmhg kpa 1 mmhg = (1mmHg) x Newton/m 2 ------------------------------ Pa ---------------------------.0075 mmhg Newton/m 2 1 kpa ------------------ = 1000 Pa 1 kpa ------------ 7.5 7.5 mmhg = 1 kpa mmhg kpa mmhg 7.5 kpa mmhg kpa 7.5 Edwards Lifesciences D-2

D.4 dn-s/cm kpa-s/l 1 dn s/cm = (1 dn s/cm ) x 1000 3 -------------------- 0.1 x ----------------------- x = ( ) 2 ----------------- 1 1 ---------------------------- 1000 10 10.0 dn-s/cm 5 = 1 kpa-s/l dn-s/cm5 kpa - s/l dn-s/cm 5 10.0 kpa-s/l dn-s/cm 5 kpa-s/l x 10.0 D.5 g/dl mmol/l 1 g/dl = 1 ----- 1 x -------------------- x x x 4 = 64, 458 ------------------------ 1000 ----------- 10 1 ----------------------------- 0.6206 1 1 mmol/l = ( ) ----------------- 0.6206 g/dl mmol/l g/dl x 0.6206 mmol/l g/dl mmol/l 0.6206 D-3 Edwards Lifesciences

Vigileo Edwards Lifesciences D-4

E E.1..........................................................E-2 E.2................................................E-2 E.3........................................E-3 E.4 /..............................E-3 E.4.1..................................E-4 E.4.2....................E-4 E.5..................................E-4 E.6............................................E-4 E.7 Edwards Lifesciences....................................E-5 E.8................................................E-6 E.9..............................................E-6 E.10.........................................................E-6 E-1.............................E-5

Vigileo E.1 E.2 70% 10 Edwards Lifesciences E-2

E.3 70% 1. 2. 3. EO E.4 / 1. 2. - 5 3. 3 5 20 4. NaCl E-3 Edwards Lifesciences

Vigileo E.4.1 1. 2. 3. E.4.2 1. CO 2 2 2. 2 E.5 70 EO E.6 12 ( Edwards Lifesciences E-4

E.7 Edwards Lifesciences 102-0085 2-8 03-5213-5700 ( ) 03-5213-5701 E-1 E-5 Edwards Lifesciences

Vigileo E.8 E.9 E.10 Edwards LifesciencesEdwards 1 Edwards Edwards Edwards Edwards Edwards Lifesciences E-6

F F.1.................................................... F-2 F.2.................................................. F-2 F-1.......................................... F-2 F-2................................... F-3 F-3 ( RF RF)....................... F-4 F-4 RF................................................ F-5 F-5...... F-5

Vigileo F.1 F.2 :EN 60601-1-2:2001 EMC EMC F-1 - RF CISPR 11 RF CISPR 11 IEC 61000-3-2 / IEC 61000-3-3 1 B A RF RF Edwards Lifesciences F-2

F-2 IEC 60601-1-2 (ESD)IEC 61000-4-2 / IEC 61000-4-4 ±2 ±4 ±6 kv ±2 ±4 6 kv ±2, ±4, ±8 kv ±2 ±4 8 kv 30% ±1 kv AC ±2 kv - ±1 kv > 3 +/- 0.5, +/- 1 kv +/- 2 kv - < 3 ±-0.5 1 kv +/-2 kv < 3 ±0.5 ±1 kv ±1 kv IEC 61000-4-5 ±0.5 ±1 ±2 kv - ±2 kv IEC 61000-4-11 (50/60 Hz) IEC 61000-4-8 <5% U >95% U 0.5 40%U (60% U ) 5 70% U (30% U ) 25 U <5% >95%U 5 / <5% U / 40% U 70% U <5% U 3 A/m 3 A/m :U AC F-3 Edwards Lifesciences

Vigileo F-3 ( RF RF) IEC 60601-1-2 RF RF IEC 61000-4-6 RF IEC 61000-4-3 3 Vms150 khz ~ 80 MHz 1 Vrms d = [3.5] x P ; 150 khz to 80 MHz d = [1.2] x P ; 80 MHz to 800 MHz 3 V/m80 ~ 2500 MHz 3 V/m d = [2.3] x P ; 800 MHz to 2500 MHz P (W) d (m) RF Edwards Lifesciences F-4

F-3 ( RF RF) IEC 60601-1-2 ( / ) AM FM RF RF 150 khz 80 MHz 1 V/m 1 :80 MHz 800 MH 2 : F-4 RF RF RF ( ) 150 khz 80 MHz 80 800 MHz 800 2500 MHz d = [1.2 ] x 5 P d= [1.2 ] x 2 P d= [2.3] x P ( ) ( ) ( ) ( ) 0.01 0.4 0.1 0.2 0.1 1.1 0.4 0.7 1 3.5 1.2 2.3 10 11 3.8 7.3 100 35 12 23 d P ( ) 1 :80 MHz 800 MH 2 : F-5 9' 2.7 m 15" 38.1 cm 8.7' 2.65 m F-5 Edwards Lifesciences

Vigileo Edwards Lifesciences F-6

G APCO CO CI 1 (SV) CO 1 1 (SVI) 1 1 SVV 1 SVR ( ) (SVRI) BSA CVP ( ) ScvO 2 /SvO ScvO 2 SvO 2

Vigileo (MAP) HGB (Hct) PR 1 Edwards Lifesciences G-2

H 1 SQI7-26 1 (SV) G-1 1 (SVI) G-1 1 SVV G-1 2 SQI ( )7-26 3 SQI7-26 4 SQI7-26 A A/D 8-17, 8-18 AC 5-4, 5-5 APCO 1-3 1-5, G-1 B BP 1-5 BSA 6-4 1-5 3-3 BSA B-3 C CAN/CSA-C22.2 2-17 CF 5-7 CI 1-5 CI > CO 12-4 CISPR 11 F-2 CI B-3 CO 1-5 3-5 CO 5-10, 6-2 6-3 CO 6-4 CO 6-3 CO/CI 5-10 COM 5-7 CVC 1-5 CVP 8-16, 8-17, 8-18 1-5 CVP º 12-8 D dn-s/cm5 kpa-s/l D-3 Dubois B-3 E Edwards Lifesciences E-5 EN 60601-1-2 2001 F-2 EN60529 2-17 EN60601-1 2-17 EN60601-1-4 2-17 EN60601-2-49 2-17 English (UK) 4-9 English (US) 4-9 EO 1-5 F FloTrac 6-8 FloTrac 5-7 FloTrac 6-8, A-5 G g/dl mmol/l D-3 H Hct 1-5 Hct 7-8 HGB 1-5 HGB 7-21 HGB 10-9 HGB 7-8 I IEC 61000-3-2 F-2 IEC 61000-3-3 F-2 IEC 61000-4-2 F-3 IEC 61000-4-4 F-3 IEC 61000-4-5 F-3 IEC 61000-4-11 F-3 IEC 61000-4-8 F-3 IEC/EN 60601-1 3-2 IEC/EN 60950 3-2 IFM 8-14 IPX1 2-17 IV A-5 M mmhg kpa D-2 N NVRAM 1-5 O OM 12-5 OM 7-19 OM 7-19 OM 10-9 - 1 Edwards Lifesciences

Vigileo Monitor Operator s Manual OM 12-5 OM 12-5 P PAC 1-5 POST 3-2, 4-7 1-5 PR 1-5 RF F-2 R S ScvO2 1-3 1-5 3-4 ScvO2 5-11, 7-3 ScvO2 3-4 SQI 7-3, 7-26 1-5 SQI = 4 12-6 SQI 7-26 SV 1-5 SVI 1-5 SVI B-3 SvO2 1-3 1-5 SvO2 7-3 SvO2 A-4 SVR 12-8 1-5 SVRI 1-5 SVRI B-3 SVR B-3 SVV B-3 1-5 SV B-3 U UL 60601-1 2-17 USB 5-7 USB A-3 USB 11-2 USB 11-2 G-1 1-5 4-3 7-26 /IR 12-5 SQII 7-26 12-5 7-25 HGB 7-21 3-7, 6-8 12-3 A-5 5-7, A-3 8-19 8-19 8-20 8-20 5-7, A-3 8-4 8-4 8-16 8-15 5-15, 7-6 7-3 7-3 5-15, C-2 6-6 G-1 / 5-15 8-9 5-16 5-17 G-1 5-17 5-16 2-2 HGB 10-9 OM 10-9 10-9 10-9 10-9 10-9 10-9 10-9 10-9 10-9 10-8 5-4 D-2 7-11 7-14 1-2, 1-3 G-1 OM 7-20 7-3 7-10, 7-11 5-11, 7-3 7-4, 7-5 5-4 A-5 Edwards Lifesciences - 2

E-4 12-7 10-9 4-5 4-5 7-18 5-7 24 12-7 7-24 / 5-4 8-9 4-1, 4-2 F-5 1-5 A-5 7-25 7-14 7-4 1-1 A-3 4-3 3-3 6-4 8-4 8-6 1-2 10-9 12-2 2-15 7-26 A-3 5-5 A-2 2-17 3-2 2-10 2-15 2-11 2-12 5-4 1-5 4-7 A-4 7-3 7-11 7-8 7-12 8-17 8-18 F-5 A-3 3-1 A F-2 B RF F-2 I 2-17 6-10 10-2 10-5 10-6 10-4 1 RF F-2 2-3 2-3 2-5 2-6 5-15 2-2, 5-17 10-14 10-14 E-3 F-5 FloTrac 6-8 4-5 E-4 12-3 F-5 12-6 7-15 10-9 4-9 8-8 8-8 5-13, 9-4 6-9 5-13, 9-4 IEC 61000-3-2 F-2 8-9 8-9 5-8 E-3 5-6 5-3 5-7 1-3 G-1 5-3 2-16 - 3 Edwards Lifesciences

Vigileo Monitor Operator s Manual 1-4 IEC 61000-4-5 F-3 8-19 8-19 8-19 FloTrac A-5 5-16 E-4 4-3 ScvO2/SvO2 G-1 B-1 7-15, 12-6 7-26 1-4 8-10 8-10 E-4 E-3 A-3 E-6 A-2 1-2 5-7 8-4, 8-12 8-13 8-4, 8-5 B-3 (CI) G-1 6-2 12-3 6-4 (CO) G-1 6-2 10-13 10-5 10-9 5-13, 9-4 9-3 5-12 9-2 5-12, 9-3 10-13 6-6 5-11, 8-3 8-4 8-4 G-1 5-15 E-4 E-3 E-4 E-3 E-2 6-4 4-1 5-13 5-13 8-12 5-12 8-8 FloTrac A-5 F-3 6-8 3-7 10-9 10-9 10-10 1-1 2-3 7-8 10-9 7-11, 12-6 (SVR) G-1 (SVRI) G-1 6-4 7-12 10-9 7-14 (BSA) G-1 B 2-17 CF 2-17 5-9, 5-14 D-1 SQI 7-26 2-6, 2-7 2-6, 2-7 2-9 2-2, 2-9, 8-21 Edwards Lifesciences - 4

2-2, 3-3, 5-16, 8-11, 8-12, 10-3, 10-11, 10-14 (CVP) G-1 1-3 C-2 SQI 7-26 1-2 E-4 E-4 5-3 8-8 OM 7-19 5-9 5-14 10-2 10-2 8-13 5-9 A-3 5-12 8-21 G-1 8-10 A-3 / F-2 / F-3 4-4 A-5 5-4 F-2 F-2 RF IEC 61000-4-6 F-4 F-3 5-4 12-2 E-4 E-4 1-4, A-5 7-11 7-3 C-2 10-5 10-6 10-4 7-6 6-6 6-8 1-3 1-3 12-3 5-4 5-12 6-4 6-10 SVR 1-2 IFMout 8-14 7-5, 7-6, A-4 CO CI 6-6 8-19 10-9 12-5 5-13, 9-4 9-3 / 5-12 5-12 5-12, 9-3 A-3 CO/CI 5-10 6-2 6-2 10-14 5-12 5-12 5-8 SQII 7-26 10-11 10-13 10-14 10-14 10-13 10-12 10-12 / 8-10 / 8-10 12-4 / 5-15 4-2, A-5 3-2 2-5 5-8 CO 5-10, 6-2 CO 6-3 CO 6-3, 6-4 - 5 Edwards Lifesciences

Vigileo Monitor Operator s Manual 5-11, 7-3 5-8 5-11, 8-3 5-9, 5-14 5-14 / 5-12 5-4 8-14 5-4 A-2 1-3 A-5 A-5 6-10 (MAP) G-2 6-10 (Hct) G-2 7-8 (HGB) G-2 7-8 12-2 5-4 RF IEC 61000-4-3 F-4 E-6 5-4 2-11 5-5 8-15 D-2 4-3 7-26 1-3 PR G-2 5-11, 8-3 CO 6-3, 6-4 8-19 8-15 7-4, 7-5 9-2 8-4 10-10 6-6 E-6 2-6 3-2 E-6 E-2 4-4 4-4 1-2 2-15 1-4 4-3 3-2 4-3 4-1 4-4 2-6, 2-7 4-2 4-4 2-12 2-11 2-9 2-6 5-6 2-12 5-8 5-3 5-4 2-11 5-3 5-3 2-10 CO 3-5 5-7 G-1 A-4 1-2 E-6 7-24 1-5 10-8 11-2 11-2 Edwards Lifesciences - 6

( ) Edwards Lifesciences 93/ 42EEC 3 CE Edwards Lifesciences Edwards E Vigileo FloTrac SAT-1 Edwards Lifesciences Corporation Edwards Lifesciences 2004-2005 Edwards Lifesciences LLC All rights reserved.a/w Part No 195129001A

Tel (011) 261-6810 Tel (052) 735-7610 Tel (082) 242-2425 Tel (022) 225-4743 Tel (06) 6350-6341 Tel (092) 281-5414 Tel (03) 5213-5710 EWL-140-337

SVV SVV SVV SVV SVV SVV <> <> 1 7,220,230 1/31

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English US // 12 English UK.. 24 Français.. 24 Deutsch.. 24 Italiano.. 24 Español.. 24 Svenska.. 24 Dansk.. 24 Nederlands.. 24 Português.. 24 Polski.. 24 e tina.. 24 Magyar.. 24 E v.. 24 // 24.. 24 Norsk.. 24 10/31

I I 4 1 4 CO/CI CO/CI SV/SVISVV SV/SVI SVV 2 11/31

CO/CI 12/31

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50mmHg 5 10 PR BP PR BP 20 14/31

8.2.16USB _< >_< >.xml USB ID BSA CO CI SV SVI SVV SVR SVRI ScvO2/SvO2 SQI Avg PR Avg BPCVP PRV SVV CO/SVR 15/31

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CO 20 5 19/31

CO CO CO SVV SV/SVI 2-6 CO SV SVI SVV 20 SV / ml/b SVI / / ml/b/m 2 SVV SVV SV/SVI 20/31

CO/CI SVV SV/SVI CO/CI / 5 30 CO/CI SV/SVI SVV 20 2 1 21/31

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5 SVV SVV SVV / CO 5 30 CO/CI SV/SVI SVV 20 2 26/31

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