EUROSETS ECMOLIFE - Page 2

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INDEX
1. GENERAL INFORMATIONS ............................................................................................................................... 5
1.1. SAFETY NOTES .................................................................................................................................................. 5
1.2. DEFINITIONS ....................................................................................................................................................... 5
1.3. DESCRIPTION ..................................................................................................................................................... 6
1.4. INTENDED PURPOSE ........................................................................................................................................ 6
1.5. PATIENT POPULATION ...................................................................................................................................... 6
1.6. INDICATIONS FOR USE ..................................................................................................................................... 6
1.7. CONTRAINDICATIONS ....................................................................................................................................... 7
1.8. INTENDED USER AND ENVIRONMENT ........................................................................................................... 7
1.9. CLINICAL BENEFITS .......................................................................................................................................... 7
1.10. RISKS AND SIDE EFFECTS ........................................................................................................................... 7
1.11. GENERAL WARNINGS ................................................................................................................................... 8
1.11.1. WARNINGS FOR THE DEVICE ............................................................................................................. 8
1.11.2. WARNINGS FOR THE PATIENT ............................................................................................................ 8
1.11.3. WARNINGS FOR THE PATIENT TRANSPORT .................................................................................... 9
1.12. CAUTION ......................................................................................................................................................... 9
1.13. MEDICAL DEVICES FOR USE WITH ECMOLIFE SYSTEM ......................................................................... 9
1.14. SYMBOLS DESCRIPTION ............................................................................................................................ 10
1.15. TRANSPORT AND STORAGE CONDITIONS .............................................................................................. 11
1.16. LIMITED WARRANTY ................................................................................................................................... 11
2. SYSTEM COMPONENTS ................................................................................................................................. 12
2.1. GENERAL DEVICE DESCRIPTION .................................................................................................................. 12
2.2. CONSOLE .......................................................................................................................................................... 16
2.2.1. FRONT PANEL ........................................................................................................................................... 18
2.2.2. REAR PANEL ............................................................................................................................................. 19
3. SENSORS SETUP ON TUBING ....................................................................................................................... 20
3.1. DISPOSABLE CUVETTE FOR VENOUS PROBE AND CONNECTION ON TUBING SET ............................. 20
3.2. VENOUS PROBE CONNECTION ONTO THE DISPOSABLE CUVETTE ........................................................ 21
3.3. CLAMP-ON TRANSDUCER (FLOWMETER) CONNECTION ON THE TUBING ............................................. 22
3.4. ECMOLIFE AND LANDING MONITOR FLOW MEASUREMENT .................................................................... 22
3.5. BUBBLE SENSOR CONNECTION TO THE TUBING....................................................................................... 22
3.6. LOGICAL PRESSURE TRANSDUCER AND SMITH MEDICAL PRESSURE SENSOR CONNECTION TO THE
ECMOLIFE CONSOLE ...................................................................................................................................... 23
3.7. EDWARDS PRESSURE SENSOR CONNECTION TO THE ECMOLIFE CONSOLE ...................................... 24
4. DISPOSABLE CENTRIFUGAL PUMP AND OXYGENATOR SETUP ................................................................ 25
5. ECMOLIFE DRIVER MOTOR HOLDER AND SETUP ....................................................................................... 26
6. DISPLAY ........................................................................................................................................................... 27
7. PRIMARY UNIT ................................................................................................................................................ 28
7.1. DISPLAY ............................................................................................................................................................ 28
7.2. TOOLBAR .......................................................................................................................................................... 31
7.3. PARAMETERS ................................................................................................................................................... 37
7.4. FUNCTIONALITIES ........................................................................................................................................... 40
7.4.1. TURNING ON THE DEVICE....................................................................................................................... 40
7.4.2. DIAGNOSTIC PHASE ................................................................................................................................ 41
7.4.3. PARAMETERS CONFIGURATION PHASE............................................................................................... 42
7.4.4. PRIMING PHASE ....................................................................................................................................... 44
7.4.5. OPERATING MODE ................................................................................................................................... 47
7.4.6. BLOOD FLOW MONITORING MODE (ADDITIONAL MODE) ................................................................... 48
7.4.7. LPM CONTROL ENABLED/DISABLED MODE VIEW ............................................................................... 49