Instructions for use: Ikus - Berlin Heart

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EXCOR cannulas Description: Blood pump, cannulas, accessories EXCOR blood pumps consist of a transparent polyurethane (PU) housing divided by a flexible triple-layer membrane into a blood chamber and an air chamber. From the blood chamber, an inflow or outflow stub lead to an inflow or outflow cannula. The stubs themselves consist of PU. At their ends, there are titanium connectors to which the cannulas are attached. Mechanical valves in the stubs guarantee a targeted blood flow. EXCOR blood pumps are available with tilting-disk valves (50 - 80 ml stroke volume) or trileaflet valves made from polyurethane (10 - 80 ml stroke volume). The blood contact surface of the pump is coated with Carmeda ® BioActive Surface (CBASTM ). The transparent housing of the blood pump permits easy visual inspection, so that the filling and emptying and the status of the blood chamber can easily be monitored. By means of the de-airing nipple in the blood chamber, the pump is de-aired during commissioning with the aid of the de-airing set. The air chamber of the pump is equipped with a driving tube connector. This connects to the air-conducting driving tube that links the pump to the Driving Unit Ikus. With suction and driving pressures, the Ikus actuates the triple-layer membrane of the blood pump. To minimize friction, there is graphite powder between the individual membranes. 3.2 EXCOR cannulas For EXCOR, three cannula types in three different sizes are offered: • Atrial cannulas (inflow cannulas) • Apex cannulas (inflow cannulas) • Arterial cannulas (outflow cannulas) The cannulas consist of tissue-friendly silicon. Suture rings made from polyester velour permit fast and safe anastomosis of the cannulas. The midsection of every cannula is sheathed with polyester velour to ensure good inward movement of the cannula. Some arterial cannulas possess a flexible metal reinforcement that permits the adjustment of the cannulas to the anatomical conditions. Some atrial cannulas are delivered with a mandrin. 1 2 3 Cannula heads: 1) Atrial cannula, 2) apex cannula, 3) arterial cannula 10 1000002 Rev. 4.9.1
3.3 EXCOR accessories For the commissioning and operation of EXCOR, the following EXCOR accessories are required: • One driving tube (PVC) per blood pump • Accessory set: T00L-001 for blood pumps with tilting-disk valves • Pressure gauge set with pressure gauge • De-airing set (2 x trocar, 2 x de-airing tube) • De-airing hammer • Tube attachment set (cable tie strap, cable tie pliers) T00L-002 for blood pumps with PU valves • Membrane set • De-airing set (2 x trocar, 2 x de-airing tube) • De-airing hammer • Tube attachment set (cable tie strap, cable tie pliers) EXCOR accessories 1000002 Rev. 4.9.1 11
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 22 and 23: Disposal General product informatio
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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