Page 1 ® EXCOR Ventricular Assist Device Ikus stationary driving unit Instructions for clinical use Edition 3 EXCOR Adult EXCOR Pediatric ® ® 1000489x03...
Page 2 1000489x03...
Page 3 Berlin Heart GmbH. This excludes the sample copies in the appendix. These instructions for use are intended for information purposes only. The contents of the instructions for use may be supplemented, modified or updated at any time without prior notice.
Page 4 1000489x03...
Page 5: Table Of Contents
Contents Contents Contact Introduction Important Safety Information General warnings ......................13 Storage ..........................14 Operational and environmental conditions ............... 14 Connectors and user controls................... 15 Laptop and monitor program .................... 16 Interaction with other procedures and therapies .............. 16 General Product Information Intended use........................
Page 6 Contents 7.3.5 Cursor navigation ......................49 7.3.6 Adjusting parameters and settings ................49 7.3.7 Scrolling through the message window ............... 50 Options for pausing and switching off devices ..............50 7.4.1 Driving unit pause: pausing both blood pumps............51 7.4.2 Pause left/Pause right: pausing individual blood pumps ..........
Page 7 Contents 10.17 Backup processor reports incorrect testing ..............79 10.18 Measurement discrepancy in main computer (or backup computer)........ 80 10.19 The error is only detected by the active (or passive) controller ........80 10.20 Parameter set update failure! ................... 80 10.21 Temperature sensors: <<8-digit binary code>>..............
Page 8 Contents mobile RF telecommunications devices and Ikus 1.0..........116 Appendix 16.1 Product range ......................... 119 16.2 Symbols.......................... 120 16.3 Sample copy: EXCOR parameter log................121 16.4 Sample copy: Ikus follow-up form................... 122 Abbreviations Index 1000489x03...
Page 9: Contact
+49 (0)30 81 87 27 72 Medical and technical assistance 24 hours a day / every day for clinical personnel Manufacturer Berlin Heart GmbH Telephone: +49 (0)30 8187 2600 Wiesenweg 10 Mon - Fri 8:00 am - 6:00 pm 12247 Berlin...
Page 10 Contact 1000489x03...
Page 11: Introduction
The line is open 24 hours a day. It may take up to 90 seconds to connect. You can reach Berlin Heart GmbH at +49 (0)30 81 87 26 00. Use this number if you have any questions relating to EXCOR.
Page 12 Introduction Instructions Instructions are marked as follows: The individual steps are numbered sequentially. Definitions of terms Product life Period of time over which the product may be used. As a rule, no further maintenance or repairs will be performed after this period.
Page 13: Important Safety Information
Important Safety Information Important Safety Information Heed the instructions for use on EXCOR sterile components! IMPORTANT: Also pay attention to the action-related safety information in the rele- vant chapters! General warnings WARNING The EXCOR system and its components may only be used when pre- scribed by the attending physician.
Page 14: Storage
Important Safety Information For Ikus 1.0 only: When using EXCOR 10 ml blood pumps, the follow- ing messages may not be generated:Please check left (or right) driv- ing line Left (or right) pump is filling insufficiently. Therefore, with 10 ml pumps in particular, check that the membrane is moving, and that the blood chambers are filling and emptying com- pletely.
Page 15: Connectors And User Controls
Important Safety Information CAUTION Before first commissioning the Ikus, ensure that the ambient conditions are appropriate. Otherwise, functional limitations or damage to the Ikus may result. See section 14: Technical specifications, page 107. Electrical safety, electromagnetic compatibility WARNING Do not use Ikus in the immediate vicinity of, or stacked together with, other equipment.
Page 16: Laptop And Monitor Program
Important Safety Information If several electrical devices are located in the vicinity of the patient, con- nect the devices to a central grounding point. Otherwise, there is a risk of electric shock or electrical damage to the EXCOR system. Use the potential equalization connector on the Ikus for this purpose. See Tab.
Page 17 Important Safety Information If Ikus is combined with other procedures or therapies, be sure to ob- serve the EMC regulations. See chapter 15: EMC Tables, page 109. No disruption to be expected In view of the electromagnetic shielding of the Ikus, the procedures and therapies list- ed herein are not expected to cause any disruptions to the Ikus system.
Page 18 Important Safety Information 1000489x03...
Page 19: General Product Information
Intended use Brief description Ikus is a pneumatic driving unit for use with the EXCOR VAD ventricular assist device. Ikus may only be used for this purpose, as well as in accordance with the specifica- tions of the respective EXCOR blood pump(s).
Page 20: Manufacturer's Guarantee
Manufacturer's guarantee Heed the instructions for use on EXCOR sterile components! The General Terms and Conditions of Business of Berlin Heart GmbH apply. The legal guarantee is valid only when the device is stored as instructed and used as directed, and when the packaging is intact. Batteries, as wearable components, are excluded from the legal guarantee.
Page 21: Maintenance
General Product Information EXCOR may only be operated with EXCOR components in accordance with the indi- cations, contraindications and instructions. If a component is damaged, the Manufacturer's Service Team must be informed im- mediately. Do not use components that are damaged. Maintenance If the Ikus is not in operation, it requires maintenance every 6 months.
Page 22 General Product Information 1000489x03...
Page 23: Description
Description Description Overview The Ikus electro-pneumatic driving unit supplies the blood pump(s) with driving and suction pressure. The enclosure of the driving unit contains pneumatic and electronic components, and a laptop as the user interface. 1 Laptop with monitor program 2 Lifting bar 3 Connector for power cable 4 Identification plate with version infor-...
Page 24: Displays And User Controls
Description Role of the active control computer: • To control the pneumatic systems • To send status information to the laptop Laptop with monitor program Tasks and functions: • Commissioning of the system • Adaptation of driving unit parameters • Displaying information on system status (pressure curves and messages) •...
Page 25 Description Ikus 1.0 Ikus 2.1 from Significance/function SW 3.33 SW 3.40 Ikus 2.1 SW 3.41 1 socket (red) for driving tube BVAD: left blood pump Connect the plug of the driving tube with the red marking here. LVAD, RVAD: Use this socket. 2 socket (blue) for driving tube BVAD: right blood pump...
Page 26 Description Ikus 1.0 Ikus 2.1 from Significance/function SW 3.33 SW 3.40 Ikus 2.1 SW 3.41 On/Ein or I On/Ein or I 7 Main switch (key switch) Ikus is switched on. Off/Aus or Off/Aus or 7 Main switch (key switch) Ikus is switched off. 8 Potential equalization connec- tion Should several electrical devices be...
Page 27: Display And Control Panel
Description External alarm connector Alarm sounds if contact... Default setting opened possible configuration closed Please contact the Service department for this: service@berlinheart.de Tab. 5-2 Configuration: External alarm connector 5.2.2 Display and control panel Fig. 5-3 Display and control panel; here: Ikus 2.1 Symbol Significance/function Ikus 1.0...
Page 28: Power Supply
Description Fig. 5-4 Operating hours counter and charge level indicator (7 or 8 yellow LEDs, depending on model) Charge level indicator • 7 or 8 yellow LEDs (depending on model): gradually go out as discharging con- tinues • Red LED: illuminates when the batteries are completely empty Operating hours counter •...
Page 29: Laptop With Monitor Program
Description Laptop with monitor program See section 7.3: Basic instructions for the monitor program, page 46. The laptop is integrated into the Ikus enclosure. The laptop, with integrated monitor program, is used to start the system; parameters can be adjusted and checked. The running monitor program provides the user with a constant stream of data about the status of the system as well as information about events and malfunctions.
Page 30: Safety And Redundancies
Description Safety and redundancies 5.6.1 Pneumatic systems Normal operation Failure of... System 1 System 2 System 3 1 system 2 systems (backup) LVAD/ Supplies Redundancy 2. system sup- Backup opera- RVAD the blood plies the blood tion: pump pump 3. system sup- 3.
Page 31: Battery Operation
Description 5.6.3 Battery operation If the power supply fails, the batteries will power the system for at least 30 minutes. See section 5.3: Power supply, page 28. 5.6.4 Manual pump The supplied manual pump can be used temporarily to operate the blood pump if a functional Ikus is no longer available.
Page 32 Description 1000489x03...
Page 33: Packaging And Shipment
Packaging and Shipment Packaging and Shipment Unpacking the Ikus WARNING Always place the Ikus on a stable, flat surface. Otherwise, the Ikus could topple over, become damaged, or the brakes may be released due to overloading. IMPORTANT: Do not dispose of the transport crate! It will be needed whenever the Ikus has to be transported.
Page 34: Packing And Shipping The Ikus
Packaging and Shipment Packing and shipping the Ikus CAUTION Always use the supplied transport crate when shipping the Ikus. Make sure that the Ikus is standing firmly and securely in the crate and that the crate is closed properly. Only move the transport crate as shown. Do not tilt the transport crate or allow it to fall.
Page 35 Packaging and Shipment Place the prepared accessories box in the space beneath the connection panel and secure on all sides with stretch film. Fig. 6-3 Positioning the accessories box Wrap the film around in such a way that the wheels on the opposite side are fixed in position.
Page 36 Packaging and Shipment 12. The transport crate is now ready for shipping. Fig. 6-7 Transport crate ready for ship- ping Type 2 transport crate (gray, on wheels) Place the back of the transport crate against a wall and/or lock the brakes to prevent the crate from moving while loading.
Page 37 Packaging and Shipment Check that the manual pump is posi- tioned firmly in its holder. Place a plastic bag over the Ikus and secure on all sides with stretch film. Fig. 6-10 Packing the Ikus into the plastic Push the Ikus straight up the ramp and into the crate.
Page 38 Packaging and Shipment 13. Fold up the ramp. Fig. 6-13 Folding up the ramp 14. Secure the ramp with the safety retainer. Fig. 6-14 Ramp secured 15. Close and lock the front door. Fig. 6-15 Closing the locking mechanism 16. Secure each locking mechanism with a cable tie.
Page 39 Packaging and Shipment 17. The transport crate is now ready for transportation. Fig. 6-17 Transport crate ready for transportation 1000489x03...
Page 40 Packaging and Shipment 1000489x03...
Page 41: Instructions For Use: Ikus
Instructions for Use: Ikus Instructions for Use: Ikus See also chapter 8: Commissioning and Preparing for Surgery, page 59. WARNING Do not install any other software on the laptop! Otherwise, the Ikus soft- ware may be corrupted. Ensure that the <Numlock> key on the laptop is not activated. The sta- tus LED on the laptop, indicated with a lock and/or a number (e.g., 1), must not be illuminated.
Page 42: Switching On The Ikus
Instructions for Use: Ikus 1 <Caps Lock> key 1 <Shift> key Fig. 7-2 Deactivating <Caps Lock> 1 Press the <NumLk> key Fig. 7-3 Deactivating <NumLk> Switching on the Ikus See chapter 8: Commissioning and Preparing for Surgery, page 59. Start menu The language selection menu will appear first when the laptop is switched on.
Page 43: Selecting Options From The Start Menu
Instructions for Use: Ikus The start menu will then appear. It contains the following options: Fig. 7-5 Start menu Option Function 1. Start program Start the monitor program. 2. Access code To edit the password-protected user profiles for the creation monitor program.
Page 44: Configuring The Access Code
Instructions for Use: Ikus 7.2.2 Configuring the access code A personalized access code is required in order to perform the standard operating pro- cedures in the monitor program. The default access code is used for managing the personalized access codes. IMPORTANT: The user number and password of the default access code can be found in the password envelope supplied in the enclosed accessories box.
Page 45: Reading The Log Files
Instructions for Use: Ikus Additional options in the access code program Action <ESC> Discards any entries not yet confirmed with <0>; ends the access code program <ENTF> Deletes the selected user (press <Enter> to confirm) <5> Opens the "Help" menu Tab.
Page 46: Updating The Date And Time
Instructions for Use: Ikus 7.2.4 Updating the date and time Fig. 7-7 Updating the date and time If the monitor program is running: exit the monitor program by pressing <F10> and confirm the decision in the window by pressing <X> or <1>. Select 5.
Page 47: Ending The Monitor Program
Instructions for Use: Ikus 7.3.2 Ending the monitor program WARNING Only end the monitor program in an emergency. The nature of a mes- sage cannot be determined if the monitor program has been ended. If the monitor program has been ended, only an acoustic alarm and the indicator on the handle of the Ikus will signify the existence of messag- es.
Page 48: Normal View Of Monitor Program
Instructions for Use: Ikus sponding message has appeared. See section 10.11: Alarm circuit defective - audible alarm remains off (or on), page 78 or section 10.28: Acoustic alarm not correctly rec- ognized, page 84. IMPORTANT: The self-test will not take place if, when logging in, an alarm is pending which has been muted temporarily by pressing the Audio paused key.
Page 49: Cursor Navigation
Instructions for Use: Ikus Functions of the monitor program Monitoring and controlling the system: • If necessary: Parameter adjustment • Systolic driving pressure • Diastolic suction pressure • Rate • Relative systolic duration (% systole) • BVAD (synchronous mode; asynchronous mode; separate mode left/right) •...
Page 50: Scrolling Through The Message Window
Instructions for Use: Ikus Settings (e.g., synchronous mode, asynchronous mode, L/R separate) Move the cursor to the desired field using <←> / <→>. The window will open. Move the cursor to the desired option using <↓> / <↑>, and press <Enter> to confirm.
Page 51: Driving Unit Pause: Pausing Both Blood Pumps
Instructions for Use: Ikus Switch the patient from VAD to CPB. If the patient is receiving full CPB sup- port: Pause the blood pump(s). See section 7.4.1: Driving unit pause: pausing both blood pumps, page 51. Remove the driving tube(s) from the connection socket(s) by grasping the plug by the release sleeve and pulling.
Page 52: Restarting The Blood Pump
Instructions for Use: Ikus This option is used to temporarily pause the operation of one blood pump, e.g., to pause the right blood pump in BVAD mode (Pause right), or to pause the blood pump in LVAD or RVAD mode (Pause left).
Page 53: Mains Operation And Battery Operation
Instructions for Use: Ikus CAUTION Only turn the Ikus off when all the yellow LEDs of the charge level indi- cator are illuminated, indicating that the batteries are fully charged. NOTICE To turn the Ikus off completely, turn the main switch (key switch) to OFF/AUS [0].
Page 54: Switching To Battery Operation
Instructions for Use: Ikus 7.5.2 Switching to battery operation WARNING Only disconnect the Ikus from the power supply if, according to the charge level indicator, the batteries are fully charged (all yellow LEDs illuminated). Do not disconnect the Ikus from the power supply if the battery circuit breaker has been triggered.
Page 55: Switching To Mains Operation
Instructions for Use: Ikus 7.5.3 Switching to mains operation Connect Ikus to the power supply. The mains operation indicator will be illumi- nated. The Battery operation indicator on the handle will go out. The batteries will be charged. Switching to BVAD Heed the instructions for use on EXCOR sterile components! The new blood pump to be connected must be de-aired and connected to the cannulae.
Page 56 Instructions for Use: Ikus To do so, turn the main switch (key switch) to ON/EIN [I]. The charge level indi- cator will illuminate. This counter shows the number of operating hours elapsed. The mains operation indicator is on. Wait 10 seconds. Switch on the laptop.
Page 57: Transportation Within The Hospital
Instructions for Use: Ikus Transportation within the hospital 1 Grip: for pushing the Ikus 2 Lifting bar: for lifting the Ikus Fig. 7-15 Grip and lifting bar WARNING If the patient is to be transported within the hospital, he or she must be accompanied by a member of staff trained in the use of the manual pump so that the patient is guaranteed support in an emergency.
Page 58 Instructions for Use: Ikus NOTICE Do not use corrosive agents, solutions containing dyes, or organic sol- vents for cleaning purposes, since they may affect the surface of the product. Ikus may be cleaned by wiping with an alcohol-based solution. Avoid the air vents when doing so.
Page 59: Commissioning And Preparing For Surgery
Commissioning and Preparing for Surgery Commissioning and Preparing for Surgery Heed the instructions for use on EXCOR sterile components! WARNING Whenever commissioning Ikus, make sure that a replacement Ikus will be available within 24 hours. Otherwise, adequate patient support can- not be guaranteed in case of an emergency.
Page 60: Starting The Monitor Program
Commissioning and Preparing for Surgery During operation: Connect the Ikus to the stationary protective earth via the potential equalization connector. After turning on the Ikus, pull the key out of the main switch (key switch) and store it in a safe place. The Ikus may otherwise be turned off acci- dentally.
Page 61: Set The Test Parameters
Commissioning and Preparing for Surgery Only end the monitor program in an emergency. Since the text of a message is only displayed in the monitor program, it is not possible to ascertain the nature of the message when the monitor program is end- ed.
Page 62: Moving Ikus Into The Or
Commissioning and Preparing for Surgery Starting blood pump operation Position the cursor over Step left. Press <Enter> to trigger a single step. Position the cursor over Step right. Press <Enter> to trigger a single step. will be activated. Position the cursor over OK. Press <Enter> to trigger a single step. Ikus will operate using the set parameters.
Page 63: Driving Unit Management
Driving Unit Management Driving Unit Management Intraoperative WARNING When leaving the Ikus unattended, log off from the monitor program! Otherwise, it will be possible for others to make undesired changes to the settings. 9.1.1 Disconnecting the tank units from the Ikus Driving unit pause and confirm by pressing <Enter>.
Page 64: Blood Pumps And Cannulae: Selecting The Size
Driving Unit Management If Ikus shuts down during the seal test: HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 9.1.3 Blood pumps and cannulae: selecting the size Selecting the size of the cannulae: Ikus 2.1 SW 3.41 and higher 15 ml blood pump: Ikus 2.1 SW 3.50(a) and higher Heed the instructions for use on EXCOR sterile components! Move the cursor to the desired field using <←>...
Page 65: Setting The Start-Up Parameters
Driving Unit Management Fig. 9-3 Selection of an inappropriately sized cannula (Ikus 2.1 SW 3.41 and higher) Next step: displaying the selection On switching to normal view, the selection will no longer be displayed. See section 9.1.7: Starting the blood pump (switching to normal view), page 67. By logging into the monitor program again, it is possible to view the selected sizes (cannula size: SW 3.41 and higher).
Page 66: Airing The Blood Pump In Single-Step Mode
Driving Unit Management When positioning the driving tubes, make sure they run directly towards the feet and to the side. Heed the instructions for use on EXCOR sterile components! When connecting a blood pump, make sure it is filled with sterile saline solution and the de-airing needle is in place.
Page 67: Starting The Blood Pump (Switching To Normal View)
Driving Unit Management still inactive Fig. 9-4 Single-step mode; OK field still inactive (here: Ikus 2.1) 9.1.7 Starting the blood pump (switching to normal view) WARNING Ensure that the blood pumps are completely free of air at startup. This can be done by first triggering a single step. Then, use the de-airing needle to expel any air bubbles, if necessary.
Page 68: When Selecting (Bvad): Synchronous Mode, Asynchronous Mode, Separate Mode
Driving Unit Management 9.1.8 When selecting (BVAD): synchronous mode, asynchronous mode, separate mode WARNING When using left/right blood pumps of equal size, perform echocardiog- raphy to verify that pulmonary circulation is not being overloaded. Oth- erwise, pulmonary edema may result. Heed the instructions for use on EXCOR sterile components! ADVICE Asynchronous mode: The intra-thoracic blood volume remains con-...
Page 69 Driving Unit Management For Ikus 1.0 only: When using EXCOR 10 ml blood pumps, the follow- ing messages may not be generated:Please check left (or right) driv- ing tube Left (or right) pump is filling insufficiently. Therefore, with 10 ml pumps in particular, check that the membrane is moving, and that the blood chambers are filling and emptying com- pletely.
Page 70 Driving Unit Management 1000489x03...
Page 71: Error Messages
Error Messages Error Messages WARNING Check all the information and messages in the message window of the monitor program at least once every four hours. Old messages are not immediately visible and may not be noticed, see chapter 7.3.7: Scroll- ing through the message window, page 50 Whenever an error message appears, check the blood pump(s) over several pump cycles to ensure complete filling and emptying.
Page 72: Pressure Fault In System 1 (Or 2/3)
Error Messages Cancellation messages All messages are saved in the log file together with the time of their occurrence. With some error messages, the error will correct itself after a short time. In such cases, the alarm will cease automatically and a corresponding cancellation message will appear (e.g., Left: Driving tube / pump OK in response to the error message:...
Page 73: Throttle Valve Error In System 1 (Or 2/3)
Error Messages 10.3 Throttle valve error in system 1 (or 2/3) • Throttle valve error in system 1 (left), please wait ... • Throttle valve error in system 2 (right), please wait ... • Throttle valve error in system 3 (backup), please wait ... Ikus 2.1.
Page 74: Please Check Left (Or Right) Pump And Driving Tube
<X> or <1>. Ikus will stop. Replace the driving tube. Do this by referring to the instructions for use on EXCOR VAD sterile components. Restart the blood pumps. See section 7.4.3: Restarting the blood pump, page 52.
Page 75: Please Check Left (Or Right) Driving Line
Error Messages Monitor the movement of the membrane and ensure that the pump/s is/are fill- ing and emptying completely. If filling behavior is satisfactory, Acknowledge the message in the monitor program If the message appears again, adjust the parameters slightly in an attempt to normalize the flow.
Page 76: Backup Operation Left (Or Right)
Error Messages Note, when adjusting the parameters: • An increase in diastolic suction pressure will have the greatest impact in terms of stabilizing the flow signal. • If, when changing the parameters, the cancellation message Driving tube and pump OK appears, no further action is necessary.
Page 77: System 1 (Left) Is Defective!/System 2 (Right) Is Defective
Error Messages Possible causes: • Two of the three pneumatic systems are defective. • The Ikus was run on battery power for too long (message: Emergency operation due to empty batteries: Risk of total failure!), Ikus could no longer generate any reliable values.
Page 78: Alarm Circuit Defective - Audible Alarm Remains Off (Or On)
Error Messages 10.11 Alarm circuit defective - audible alarm remains off (or on) • Alarm circuit defective - audible alarm remains off! • Alarm circuit defective - audible alarm remains on! Ikus 2.1. and higher WARNING If this message appears, Ikus is not emitting acoustic alarms, or the alarms it is emitting are malfunctioning.
Page 79: Backup Computer: Reports Faulty Measurement Left (Or Right)
Error Messages This message only appears in conjunction with an additional message. Take the action required by this additional message. Acknowledge the message in the monitor program by moving the cursor to the Alarm off field and pressing <Enter>. Otherwise, the acoustic alarm will sound again within at least 10 minutes.
Page 80: Measurement Discrepancy In Main Computer (Or Backup Computer)
Error Messages IMPORTANT: During this check, the blood pump driven by the system under testing will stop for about 10 seconds. Evaluate the status of the patient. Switch the patient to a replacement Ikus immediately. See section 11.4: Sup- port using replacement Ikus, page 94. HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 10.18 Measurement discrepancy in main computer (or backup...
Page 81: Temperature Sensors: <<8-Digit Binary Code
Error Messages If the message recurs: Switch the patient to a replacement Ikus immediately. See section 11.4: Sup- port using replacement Ikus, page 94. HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 10.21 Temperature sensors: <<8-digit binary code>> Temperature sensors: •...
Page 82: Batteries Discharged; Battery Operation Not Possible
Error Messages IMPORTANT: At the request of the Manufacturer's Service Team, read out the log files and send them to the Manufacturer. See section 7.2.3: Reading the log files, page 45. 10.23 Batteries discharged; Battery operation not possible • Batteries discharged; Battery operation not possible Ikus 2.1 SW 3.41.
Page 83: Danger: (Internal) Battery Fuse Test Failed
Error Messages Check the status of the patient. Check the filling and emptying of the blood pump(s), and monitor the function of the Ikus. Ikus Do not operate without supervision! If the message Batteries charged sufficiently does not appear within 6 hours, switch the patient to a replacement Ikus immediately.
Page 84: Electronic Systems Defective. Contact Customer Service
Error Messages HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 10.27 Electronic systems defective. Contact customer service! • Electronic systems defective. Contact customer service! This message appears if the internal power supply of the electronics is faulty. IMPORTANT: Take immediate action! Otherwise, there is a risk of total failure in the event of a further error.
Page 85: Error: No Reaction From Control Computer
Error Messages Assess the error scenario: • No alarm, Ikus still in operation: no communication between control com- puter and laptop • Visual and acoustic alarm, Ikus running in emergency pulse mode: both control computers are defective • Ikus has stopped, acoustic alarm only: power supply defective Switch the patient to a replacement Ikus immediately.
Page 86: Self-Test Not Completed By Passive Computer
Error Messages If this message appears outside of the start test: Check the status of the patient. Check the filling and emptying of the blood pump(s), and monitor the function of the Ikus. Ikus Do not operate without supervision! Switch the patient to a replacement Ikus immediately. section 11.4: Support using replacement Ikus, page 94.
Page 87: System 1 (Left) Has Reached Maximum Capacity
Error Messages Check the status of the patient. Check the filling and emptying of the blood pump(s), and monitor the function of the Ikus. Ikus Do not operate without supervision! Compare the set target parameter values with the parameter values actually generated.
Page 88: Messages During The Start Test
Error Messages 10.39 Messages during the start test This section describes the messages that only appear during the start test. Messages that appear during both the start test and ongoing operation have been described in the previous sections. IMPORTANT: Always wait for the start test to finish. Only then should any corrective action be taken.
Page 89 Error Messages If Ikus now ends the start test without a message: put Ikus into operation. If not: do not put Ikus into operation. HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 1000489x03...
Page 90 Error Messages 1000489x03...
Page 91: Detecting And Eliminating Errors
Detecting and Eliminating Errors Detecting and Eliminating Errors If there are visible defects on the Ikus: HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 11.1 Technical failures with no error message Acoustic alarm without an error message Can the alarm be muted? Alarm only brief?
Page 92: Restarting Ikus
Detecting and Eliminating Errors 11.2 Restarting Ikus WARNING If the curves in the monitor program are frozen and the parameters can- not be adjusted even after restarting the laptop and monitor program, Ikus will operate in emergency pulse mode. If this occurs do not pro- ceed as described here;...
Page 93: Emergency Pulse Mode
Detecting and Eliminating Errors Resuming patient support with the original Ikus Remove the driving tube(s) from the replacement Ikus or manual pump, and connect them to the Ikus. IMPORTANT: Pay attention to the colored markings. Each plug will audibly click into place. Check that each plug is firmly in place by pulling on the plug above the release sleeve.
Page 94: Support Using Replacement Ikus
Detecting and Eliminating Errors HOTLINE Contact the emergency hotline! +49 (0)30 81 87 27 72 Switch the patient to a replacement Ikus. See section 11.4: Support using replacement Ikus, page 94. ADVICE To facilitate error analysis by the Service Team, we recommend doing the following: Initial steps for error analysis Wait for 10 minutes.
Page 95 Detecting and Eliminating Errors Turn on the replacement Ikus. To do so, turn the main switch (key switch) to ON/EIN [I]. The battery charge indicator will light up and the elapsed operating hours will be displayed. The mains operation indicator will be illuminated. Switch on the laptop.
Page 96: Support Via Manual Pump
Detecting and Eliminating Errors Turn off the defective Ikus. If possible, log into the monitor program of the old Ikus. Select the option Driving unit OFF and confirm by pressing <Enter>. Confirm the decision in the window by pressing <X> or <1>. Ikus will come to a Driving unit OFF stop.
Page 97 Detecting and Eliminating Errors Remove the driving tube(s) from the Ikus. Do so by gripping the release sleeve and pulling out of the socket. Fig. 11-2 Manual pump without base plate (part number 1600340) Connect the driving tube(s) to the man- ual pump.
Page 98: Battery Circuit Breaker Triggered (Mains Operation)
Detecting and Eliminating Errors Visually check the blood pump to ensure • that the membrane is moving and is crease-free in the end position. • that the blood pump is filling and emptying completely. Fig. 11-6 Support via manual pump 11.6 Battery circuit breaker triggered (mains operation) WARNING If the battery circuit breaker has been triggered, do not disconnect Ikus...
Page 99: Laptop Monitor Freezes
Detecting and Eliminating Errors Start the monitor program. See section 8.1.3: Starting the monitor program, page 60. The Select operating mode view will be displayed. Select the operating mode. See section 9.1.2: Selecting the operating mode, page 63. The Pump size and single-step mode view will appear. Select the sizes for the blood pumps and cannulae, and set the parameters.
Page 100 Detecting and Eliminating Errors 1000489x03...
Page 101: Overview: Parameters And Configuration
Overview: Parameters and Configuration Overview: Parameters and Configuration 12.1 Important parameter sets Systole Diastole Rate [bpm] Rel. systolic Operating [mmHg] [mm Hg] duration [%] mode left / right left / right left / right left / right Test parameters must be set during the warm-up phase with the tank unit. See section 8.1.1, page 59 and section 8.1.4, page 61.
Page 102: Duration: Audio Paused
Overview: Parameters and Configuration 12.2 Duration: Audio paused Type of alarm Duration: Audio paused Please connect driving tube! 10 s + 8 cycles (systole + diastole) Please check left (or right) pump and driving tube! 1 min As of Ikus 2.1. Please check left (or right) driving line! 10 min (only Ikus 1.0)
Page 103: Parameters - Possible Ranges And Steps
Overview: Parameters and Configuration The given value represents the upper limit for the pump rates. Higher values are shown in red in the monitor program. The given values have been determined (in vitro) based on a mean arterial blood pressure of 120 mm Hg. Do not use rates that exceed those described here.
Page 104 Overview: Parameters and Configuration 1000489x03...
Page 105: External Alarm Connection
Possible configurations The configuration can be changed from Normally Open to Normally Closed. The change must be carried out by the Berlin Heart Service. Information on routing the connection cable •...
Page 106 External alarm connection Connection Ikus external alarm Electrical data: max. 24 V / 1 A Insulation data: 2.5 mm/4 mm air and creepage dis- tance between alarm contact and 24 V low voltage inside the device (coil side) Insulation test voltage: 500 V 1000489x03...
Page 107: Technical Specifications
Technical specifications Technical specifications Ikus Manufacturer and distributor Berlin Heart GmbH, Wiesenweg 10, 12247 Berlin, Germany Overall system (excluding blood pump) Ambient operating temperature +30 °C +10 °C with restriction of battery performance: +35 °C +10 °C Ambient temperature in storage and +50 °C...
Page 108 Technical specifications Ikus Weight Ikus 2.1: 100.6 kg Ikus 1.0: 93.0 kg Input voltage see identification plate AC 230 V 50 Hz AC 220 V 60 Hz AC 115 V 60 Hz AC 100 V 50 Hz AC 100 V 60 Hz Power consumption 575 VA Mains power fuse...
Page 109: Emc Tables Ikus 2.1
EMC Tables EMC Tables 15.1 EMC Tables Ikus 2.1 Applicable test standard: • Ikus 2.1: IEC 60601-1-2:2014 In some cases, higher test levels than those required by the test standard have been applied for measurements. If the recommended separation distances to the electromagnetic disturbances are fall- en short of, impairment or loss of the essential performance must be expected, see section 4.2: Major performance characteristics, page 19.
Page 110: Electromagnetic Immunity - Part 1
EMC Tables 15.1.2 Electromagnetic immunity - part 1 Guidance and manufacturer's declaration – electromagnetic immunity The Ikus 2.1 is intended for use in the electromagnetic environment specified below. The customer or user of the Ikus 2.1 should assure that the Ikus 2.1 is used in such an environ- ment.
Page 111 EMC Tables Guidance and manufacturer's declaration – electromagnetic immunity The Ikus 2.1 is intended for use in the electromagnetic environment specified below. The customer or user of the Ikus 2.1 should assure that the Ikus 2.1 is used in such an environ- ment.
Page 112 EMC Tables Guidance and manufacturer's declaration – electromagnetic immunity The Ikus 2.1 is intended for use in the electromagnetic environment specified below. The customer or user of the Ikus 2.1 should assure that the Ikus 2.1 is used in such an environ- ment.
Page 113: Emc Tables Ikus 1.0
EMC Tables 15.2 EMC Tables Ikus 1.0 Applicable test standard: • Ikus 1.0: EN 60601-1-2:2000 If the recommended separation distances to the electromagnetic disturbances are fall- en short of, impairment or loss of the essential performance must be expected, see section 4.2: Major performance characteristics, page 19.
Page 114: Electromagnetic Immunity - Part 1
EMC Tables 15.2.2 Electromagnetic immunity - part 1 Guidance and manufacturer's declaration – electromagnetic immunity The Ikus 1.0 is intended for use in the electromagnetic environment described below. The customer or user of the Ikus 1.0 should ensure that the Ikus 1.0 is used in such an environ- ment.
Page 115: Electromagnetic Immunity - Part 2
EMC Tables 15.2.3 Electromagnetic immunity - part 2 Guidance and manufacturer's declaration – electromagnetic immunity The Ikus 1.0 is intended for use in the electromagnetic environment described below. The customer or user of the Ikus 1.0 should ensure that the Ikus 1.0 is used in such an environ- ment.
Page 116: Recommended Separation Distances Between Portable And
EMC Tables Guidance and manufacturer's declaration – electromagnetic immunity The Ikus 1.0 is intended for use in the electromagnetic environment described below. The customer or user of the Ikus 1.0 should ensure that the Ikus 1.0 is used in such an environ- ment.
Page 117 EMC Tables Recommended separation distances between portable and mobile HF telecommunications devices and the Ikus 1.0 The Ikus 1.0 is intended for use in an electromagnetic environment in which RF interference is controlled. The customer or user of the Ikus 1.0 can help to prevent electromagnetic inter- ference by ensuring a minimum distance between portable and mobile RF telecommunica- tions devices (transmitters) and the Ikus 1.0, depending on the power output of the communications device as indicated below.
Page 118 EMC Tables 1000489x03...
Page 119: Appendix
Appendix Appendix 16.1 Product range For full product range, refer to the product catalog. Description EXCOR stationary driving unit for Ikus (230 V/50 Hz) D03I-001 EXCOR stationary driving unit for Ikus (220 V/60 Hz) D03l-002 EXCOR stationary driving unit for Ikus (115 V/60 Hz) D03l-110 EXCOR stationary driving unit for Ikus (100 V/50 Hz) D03I-112...
Page 120: Symbols
Appendix 16.2 Symbols Instructions for use Device is not safe for use must be followed! with MRI. Heed the instructions for use! Notice! Application component Type B Application component Defibrillation-proof applied Type Cardiac Floating part of Cardiac Floating type Order number Example of symbol for Num- lock status LED on the lap- Only use and store...
Page 121: Sample Copy: Excor Parameter Log
Appendix 16.3 Sample copy: EXCOR parameter log 1000489x03...
Page 122: Sample Copy: Ikus Follow-Up Form
Appendix 16.4 Sample copy: Ikus follow-up form 1000489x03...
Page 123: Abbreviations
Abbreviations Abbreviations BVAD: Biventricular assist device CISPR: Special International Committee on Radio Interference (comité international spécial des perturbations ra- dioélectriques) , CPB: Cardiopulmonary bypass CVP: Central venous pressure EMC: Electromagnetic compatibility ESD: Electrostatic discharge , IEC: International Electrotechnical Commission , ISM: industrial, scientific and medical LVAD: Left ventricular assist device MAP: Mean arterial pressure...
Page 124 Abbreviations 1000489x03...
Page 125: Index
Index Index Access code 31 Electromagnetic compatibility (EMC) 109 Alarm EMC, see Electromagnetic compatibility external (nurse call) 106 Emergency hotline 11 Muting 48 Emergency operation 76 Alarm circuit self-test 47 Parameters 101 Alarm paused Emergency pulse Duration 102 ~ circuit board 30 Ambient conditions 14 Emergency pulse mode 93 Asynchronous mode 50...
Page 126 Index Functions 49 Single-step mode 62 log file 53 Size selection for blood pumps and cannulae 64 logging in and out 47 Socket Normal view 48 Configuration 66 Starting 46 Standard parameters 101 MRI, see Magnetic resonance imaging Start menu 42 Start test Error messages during ~ 88 Routine ~ when not in use 55...
Page 127: Print Control
Print Control A B C D E F G H I J K L M N O P Q R S T U V W X Y Z a b c d e f g h i j k l m n o p q r s t u v w x y z + - * / >...
Page 128 1000489x03...

This manual is also suitable for:

Excor adult Excor pediatric

Berlin Heart EXCOR VAD Instructions For Clinical Use

Quick Links

Need help?

Questions and answers

Related Manuals for Berlin Heart EXCOR VAD

Summary of Contents for Berlin Heart EXCOR VAD

This manual is also suitable for:

Table of Contents