Instructions for use: Ikus - Berlin Heart

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Additional information: Laptop Panasonic CF29 Appendix 100 1000002 Rev. 4.9.1
14 EMC tables 14.1 Emissions characteristics Measurement of transient emissions HF emissions according to CISPR 11 HF emissions according to CISPR 11 Emissions of harmonics according to IEC 61000-3-2 Emissions of voltage fluctuations/flickers according to IEC 61000-3-3 Emissions characteristics The EXCOR stationary Driving Unit Ikus system is intended for operation in the environment described below. The customer or user of the EXCOR stationary Driving Unit Ikus system must ensure that it is used in such an environment. Compliance Electromagnetic environment - guidelines Group 1 The EXCOR stationary Driving Unit Ikus system uses HF energy only for its internal functioning. Therefore, its HF emissions are very low, and it is improbable that interference with adjacent electronic devices will occur. Class B Class A Conformant The EXCOR stationary Driving Unit Ikus system is suitable for use in all facilities including residential areas, etc., which are directly connected to a public power supply which also supplies buildings used for residential purposes. 1000002 Rev. 4.9.1 101
Page 1:
EXCOR ® VAD with Stationary Drivin
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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 .....
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INDEX Driving units 88 DT, Destinat
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INDEX System has reached maximum ca
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2 1000002 Rev. 4.9.1
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Risks and adverse effects Important
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Operator obligations General produc
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Disposal General product informatio
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
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Safety Description: Stationary Driv
Page 34 and 35:
Start menu Instructions for use: Ik
Page 36 and 37:
Fundamentals of the monitoring prog
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Stop the blood pumps, switch off th
Page 40 and 41:
Switching between mains power and b
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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 50 and 51:
Page 52 and 53:
Page 54 and 55:
Postoperative drive management Star
Page 56 and 57:
Pump with PU valve Implantation: Pr
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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 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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