Instructions for use: Ikus - Berlin Heart

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Safety Description: Stationary Driving Unit Ikus 4.6.6 Password-protected user profiles (entry code) Changes to settings in the monitoring program are only possible if a user logs on to the monitoring program with a password. In the delivery state, one user profile is preset; up to nine others can be created. All procedural steps are stored with personalization. 18 1000002 Rev. 4.9.1
5 Instructions for use: Ikus You can control and supervise the Ikus via the monitoring program installed on the laptop. The settings in the monitoring program can only be changed if a user is logged on. Warning! • Do not install any other software on the laptop! • Make sure that the key on the laptop is not activated. The status LED on the laptop indicated with a lock and/or a number (e.g. “1”) should not light up. • Only use diskettes for data storage. Never connect a USB stick to the laptop! • Once per day, check all information and messages in the message window of the monitoring program. Take any corrective action and inform Berlin Heart GmbH service if necessary. • If you are using a laptop of the type Panasonic CF29, always observe the additional information (Chp. 13.9, p. 99)! Note • To start up the Ikus, see page 31. 5.1 Start menu After starting the laptop, you first arrive at the start menu. The start menu contains the following options: 1 Start program 2 Add/ change/ delete entry code 3 End 4 Save data to floppy 5 Change date/time 6 Change language Start program: With this option, you start the monitoring program. Add/ change/ delete entry code: With this option, you can edit the password-protected user profile for the monitoring program. End: With this option, you can shut down the laptop before switching it off. The Ikus continues operating with the set parameters. Save data to floppy: With this option, the log files can be saved to disk and inspected. This should only be performed after consulting with Berlin Heart GmbH service. Change date/time: With this option, you can change the time settings of the laptop. Change language: With this option, you can change the language of the monitoring program. 5.1.1 Select options from the start menu Instructions 1. Enter the option number (e.g. for “Start program”). The option is activated immediately. Note • On starting the monitoring program, you must log on with your username and password. • To administer user profiles (Option , Add/ change/ delete entry code), you must log on with your default user profile. • The default user profile is contained in the password envelope supplied in the accessories box. Recommendation • Store the password envelope in a safe place. Start menu 1000002 Rev. 4.9.1 19
Page 1: EXCOR ® VAD with Stationary Drivin
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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 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 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
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No internal communication Error mes
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System 3 is faulty Error messages a
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Error messages during the start tes
Page 90 and 91:
Replace the blood pump(s) Detecting
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Restart the Ikus Detecting and elim
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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
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Overview: Product range and combina
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Symbols Appendix Diastolic pressure
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EXCOR standard forms implantation r
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Standard form: EXCOR pump log Appen
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Standard form: EXCOR emergency log
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Standard form: Blood pump replaceme
Page 114 and 115:
Additional information: Laptop Pana
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Electromagnetic immunity - Part 1 E
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Recommended protection distances EM
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Explanations About these instructio
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Table of contents First page.......
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Safety information 1 Important safe
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Warranty 2.5 Manufacturer's warrant
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� New transport crate 5.8 Packagi
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8. Check that the manual pump is fi
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17. Secure the latches with cable t
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Fig. 11 Recommended cannula exit si
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WARNING When using a connecting set
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Securing the connections 8.8 Securi
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If necessary: correct the settings
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Guidelines for anticoagulation ther
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Replacing the driveline 11.5.1 Repl
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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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