Instructions for use: Ikus - Berlin Heart

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Disposal General product information 8 1000002 Rev. 4.9.1
3 Description: Blood pump, cannulas, accessories EXCOR blood pumps EXCOR VAD is an extracorporeal, electro-pneumatically driven ventricular assist device. It can be used for both univentricular and biventricular heart support. EXCOR VAD consists of the following permanently active components: • Extracorporeal blood pump(s) • Inflow and outflow cannula(s) • 1 driving tube per blood pump • 1 Driving Unit Ikus Cannula Blood pump Driving tube EXCOR in situ; here as biventricular support for pediatric use Overview The blood flows from the atrium or ventricle through the inflow cannula into the blood chamber of the pump and from there through the outflow cannula into the aorta or pulmonary artery. A driving tube connects the air chamber of the pump with the electropneumatic driving unit of the Ikus. The Ikus provides the suction and driving pressures that move the triple-layer membrane between the air and blood chambers of the pump. 3.1 EXCOR blood pumps h g e i a c b Blood pump 60 ml, here with PU valves f d Driving Unit Ikus a Air chamber b Driving tube connector c Triple-layer membrane d Blood chamber (de-airing nipple on the back) e Arrow: points in the blood flow direction f Inflow stub g Outflow stub h Titanium connector: Outflow stub - Outflow cannula i Titanium connector: Inflow stub - Inflow cannula 1000002 Rev. 4.9.1 9
Page 1: EXCOR ® VAD with Stationary Drivin
Page 4 and 5: ii 1000002 Rev. 4.9.1
Page 6 and 7: 4.6.4 Battery mode.................
Page 8 and 9: 9.1.1 Example: Anticoagulation ther
Page 10 and 11: 13.3.2 Ikus: connection panel .....
Page 12 and 13: INDEX Driving units 88 DT, Destinat
Page 14 and 15: INDEX System has reached maximum ca
Page 16 and 17: 2 1000002 Rev. 4.9.1
Page 18 and 19: Risks and adverse effects Important
Page 20 and 21: Operator obligations General produc
Page 24 and 25: EXCOR cannulas Description: Blood p
Page 26 and 27: EXCOR accessories Description: Bloo
Page 28 and 29: Displays and operating elements Des
Page 30 and 31: Operating modes Description: Statio
Page 32 and 33: Safety Description: Stationary Driv
Page 34 and 35: Start menu Instructions for use: Ik
Page 36 and 37: Fundamentals of the monitoring prog
Page 38 and 39: Stop the blood pumps, switch off th
Page 40 and 41: Switching between mains power and b
Page 42 and 43: Routine start test in the event of
Page 44 and 45: Packaging and transport Instruction
Page 46 and 47: Preparations outside of the operati
Page 48 and 49: Intraoperative drive management Sta
Page 54 and 55: Postoperative drive management Star
Page 56 and 57: Pump with PU valve Implantation: Pr
Page 58 and 59: De-air the pump Implantation: Prepa
Page 60 and 61: Apex cannula(s) Implantation - Surg
Page 62 and 63: Outflow cannula(s) Implantation - S
Page 64 and 65: Connect the pumps to the cannulas I
Page 66 and 67: After the operation Implantation -
Page 68 and 69: Postoperative anticoagulation thera
Page 70 and 71: Antibiotic therapy Intensive care a
Page 72 and 73:
Regular inspection of blood pump(s)
Page 74 and 75:
Regular inspection of blood pump(s)
Page 76 and 77:
Weaning (Bridge-to-Recovery, BTR) E
Page 78 and 79:
Batteries discharged; battery mode
Page 80 and 81:
Do not operate the driving unit wit
Page 82 and 83:
FATAL: Battery failure! Inform Serv
Page 84 and 85:
No internal communication Error mes
Page 86 and 87:
System 3 is faulty Error messages a
Page 88 and 89:
Error messages during the start tes
Page 90 and 91:
Replace the blood pump(s) Detecting
Page 92 and 93:
Restart the Ikus Detecting and elim
Page 94 and 95:
Connect the patient to the replacem
Page 96 and 97:
Failure of the power supply or both
Page 98 and 99:
Battery fuse Detecting and eliminat
Page 100 and 101:
Overview: Product range and combina
Page 102 and 103:
Overview: Product range and combina
Page 104 and 105:
Symbols Appendix Diastolic pressure
Page 106 and 107:
EXCOR standard forms implantation r
Page 108 and 109:
Standard form: EXCOR pump log Appen
Page 110 and 111:
Standard form: EXCOR emergency log
Page 112 and 113:
Standard form: Blood pump replaceme
Page 114 and 115:
Additional information: Laptop Pana
Page 116 and 117:
Electromagnetic immunity - Part 1 E
Page 118 and 119:
Recommended protection distances EM
Page 120 and 121:
Explanations About these instructio
Page 122 and 123:
Table of contents First page.......
Page 124 and 125:
Safety information 1 Important safe
Page 126 and 127:
Warranty 2.5 Manufacturer's warrant
Page 128 and 129:
� New transport crate 5.8 Packagi
Page 130 and 131:
8. Check that the manual pump is fi
Page 132 and 133:
17. Secure the latches with cable t
Page 134 and 135:
Fig. 11 Recommended cannula exit si
Page 136 and 137:
WARNING When using a connecting set
Page 138 and 139:
Securing the connections 8.8 Securi
Page 140 and 141:
If necessary: correct the settings
Page 142 and 143:
Guidelines for anticoagulation ther
Page 144 and 145:
Replacing the driveline 11.5.1 Repl
Page 146 and 147:
Emergency pulse mode Changes: • T
Page 148:
Discontinuation of the mandrin 13.1
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Instructions for use: Ikus - Berlin Heart

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