Instructions for use: Ikus - Berlin Heart

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Explanations About these instructions for use the instructions for use. The contents are generally identical. Error messages and measures The messages issued by the system have been lengthened greatly to help localize malfunctions quickly and precisely. You will find detailed explanations of the individual error messages in section 11: "Error messages and corrective action", S. 63. Annex The “Standard form: Blood pump replacement” on page 98 and “Additional information: Laptop Panasonic CF29” on page 99 have been added. 106 1000002 Rev. 4.9.1
Latest News 1000095x14 Rev. 8 This document provides information about changes that have not yet been included in the instructions for use. Date of issue: 2011 - 10 Replaces: 1000095x13 Rev. 7 Product: EXCOR ® VAD with Ikus stationary driving unit Rev. 2.1 SW 3.40 Accompanying documents: Instructions for use Revision 4.9.1 This Latest News applies exclusively in connection with the above named accompanying documents. It is essential to read the accompanying documents! The safety information they contain must be followed in particular! The numbering of the sections in this Latest News refers to the relevant chapters or sections of the accompanying documents. Berlin Heart GmbH • Wiesenweg 10 • 12247 Berlin • Germany service@berlinheart.de Tel: +49 (0) 30 81 87 26 00 • Fax +49 (0) 30 81 87 27 37 www.berlinheart.de 1000095x14 Rev. 8 1/28
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EXCOR ® VAD with Stationary Drivin
Page 4 and 5:
ii 1000002 Rev. 4.9.1
Page 6 and 7:
4.6.4 Battery mode.................
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9.1.1 Example: Anticoagulation ther
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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
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EXCOR cannulas Description: Blood p
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EXCOR accessories Description: Bloo
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Displays and operating elements Des
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Operating modes Description: Statio
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Safety Description: Stationary Driv
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Start menu Instructions for use: Ik
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Fundamentals of the monitoring prog
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Stop the blood pumps, switch off th
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Switching between mains power and b
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Routine start test in the event of
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Packaging and transport Instruction
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Preparations outside of the operati
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Intraoperative drive management Sta
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Page 54 and 55:
Postoperative drive management Star
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Pump with PU valve Implantation: Pr
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De-air the pump Implantation: Prepa
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Apex cannula(s) Implantation - Surg
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Outflow cannula(s) Implantation - S
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Connect the pumps to the cannulas I
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After the operation Implantation -
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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 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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