Instructions for use: Ikus - Berlin Heart

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Standard form: EXCOR emergency log Appendix 13.7 Standard form: EXCOR emergency log 1) General Ikus serial no.: 0 - Elapsed operating hours: Date of next maintenance: Location (clinic): 2) Malfunction Notify hotline! +49(0)30 8187 2772 This log helps to record malfunctions in the Ikus. What is happening / has happened? How did the error occur? When did the error occur? Age of patient: 3) Current status: How is the Ikus working since the error occurred? Currently displayed parameters in the monitoring program Status of the patient: O stable O deteriorated Support by O UVAD O BVAD Parameter Systole Diastole Rate % systole Left Right Are the pump membranes still moving? LVAD O yes O no RVAD O yes O no BVAD: How are the pump membranes moving in relation to each other? O synchronously O asynchronously Power supply via … O mains power operation O battery mode (indicator lamp “Battery mode” lit up) How many LEDs are lit up on the charge level indicator? (please enter the number of LEDs) 4) Laptop function: How is the monitoring program working since the error occurred? Are the running curves displayed in the monitoring program? O yes O no Are messages being shown in the message window? O yes O no What operating status is shown in the parameter table? O Normal O Backup O Failure 5) Settings (before the malfunction occurred) Parameters set in the monitoring program (see EXCOR parameter log if necessary) Parameter Systole Diastole Rate % systole Left Right Operating mode O LVAD O RVAD O BVAD, operating mode:O synchronous mode,O asynchronous O separate Power supply via … O mains power operation O battery mode (indicator lamp “Battery mode” lit up) 96 1000002 Rev. 4.9.1
6) Other noticeable problems: Note • E-mail: service@berlinheart.de; Fax: +49(0)30 8187 2737 Standard form: EXCOR emergency log 1000002 Rev. 4.9.1 97
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EXCOR ® VAD with Stationary Drivin
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ii 1000002 Rev. 4.9.1
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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
Page 28 and 29:
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
Page 48 and 49:
Intraoperative drive management Sta
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Page 52 and 53:
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 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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