Table Of Contents - Eurosets COLIBRI SYSTEM Instructions For Use Manual

INDEX

1. GENERAL INFORMATIONS ................................................................................................................................... 4

1.1. SAFETY NOTES ................................................................................................................................................................. 4

1.2. DEFINITIONS ..................................................................................................................................................................... 4

1.3. DESCRIPTION .................................................................................................................................................................... 5

1.4. INTENDED PURPOSE ...................................................................................................................................................... 5

1.5. PATIENT POPULATION ................................................................................................................................................... 5

1.6. INDICATIONS FOR USE ................................................................................................................................................... 5

1.7. CONTRAINDICATIONS .................................................................................................................................................... 5

1.8. INTENDED USER AND ENVIRONMENT ...................................................................................................................... 5

1.9. CLINICAL BENEFITS ........................................................................................................................................................ 6

1.10. RISKS AND SIDE EFFECTS ........................................................................................................................................ 6

1.11. GENERAL WARNINGS ................................................................................................................................................. 7

1.11.1.

WARNINGS FOR THE DEVICE ......................................................................................................................... 7

1.11.2.

WARNINGS FOR THE PATIENT ....................................................................................................................... 7

1.11.3.

WARNINGS FOR THE PATIENT TRANSPORT .............................................................................................. 9

1.11.4.

CAUTION............................................................................................................................................................... 9

1.12. MEDICAL DEVICES FOR USE WITH COLIBRÌ SYSTEM ...................................................................................... 9

1.13. SYMBOLS DESCRIPTION ......................................................................................................................................... 10

1.14. TRANSPORT AND STORAGE CONDITIONS ......................................................................................................... 11

1.15. LIMITED WARRANTY ................................................................................................................................................ 11

2. SYSTEM COMPONENTS ..................................................................................................................................... 12

2.1. GENERAL DEVICE DESCRIPTION ............................................................................................................................... 12

2.2. CONSOLE ......................................................................................................................................................................... 14

2.2.1. TOP PANEL .............................................................................................................................................................. 15

2.2.2. DISPLAY ................................................................................................................................................................... 15

2.2.3. RIGHT PANEL .......................................................................................................................................................... 16

2.2.4. LEFT PANEL ............................................................................................................................................................ 16

3. FLOWMETER / AIR SENSOR CONNECTION ON THE TUBING...................................................................... 17

3.1. COLIBRI AND LANDING MONITOR FLOW MEASUREMENT ................................................................................ 17

4. DISPOSABLE CENTRIFUGAL PUMP AND OXYGENATOR SETUP................................................................ 18

5. USER INTERFACE ................................................................................................................................................ 19

5.1. DISPLAY ........................................................................................................................................................................... 19

5.2. TOOLBAR .......................................................................................................................................................................... 23

5.3. FUNCTIONALITIES ......................................................................................................................................................... 25

5.3.1. AUTOMATIC PRIMING AND SELF LEARNING PROCEDURE - ADULT/PAEDIATRIC CONFIGURATION

5.3.2. AUTOMATIC PRIMING AND SELF LEARNING PROCEDURE - NEW BORN CONFIGURATION ............ 27

6. ALARMS ................................................................................................................................................................. 29

6.1. ALARM RANGE AND PARAMETERS .......................................................................................................................... 29

6.1.1. ALARM LIMIT - ADULT/PAEDIATRIC CONFIGURATION .............................................................................. 29

6.1.2. ALARM LIMIT - NEW BORN CONFIGURATION ............................................................................................... 30

6.2. ZERO FLOW MODE ........................................................................................................................................................ 30

6.3. ALARMS PRIORITY ......................................................................................................................................................... 31

6.4. ALARM PAUSE ................................................................................................................................................................ 31

6.5. ALARM ACKNOWNLEDGE ............................................................................................................................................ 31

6.6. ALARMS TABLE .............................................................................................................................................................. 31

7. COMBINATION SYSTEM ECMOLIFE-COLIBRI ................................................................................................ 32

7.1. COLIBRÌ-ECMOLIFE CONNECTION ........................................................................................................................... 32

7.2. FUNCTIONALITIES ......................................................................................................................................................... 34

7.2.1. TURNING ON THE ECMOLIFE-COLIBRI' SYSTEM ......................................................................................... 34

7.2.2. DIAGNOSTIC PHASE .............................................................................................................................................. 34