Instructions for use: Ikus - Berlin Heart

EXCOR ® VAD
with
Stationary Driving Unit Ikus
Instructions for use: version 4.9.1
Berlin Heart GmbH
Wiesenweg 10
12247 Berlin
Germany
Tel.+49 (0)30. 81 87 - 26 00
Fax+49 (0)30. 81 87 - 26 01
Hotline +49 (0)30 8187 2772
service@berlinheart.de
www.berlinheart.de

Hotline: 0700-berlinheart (+49(0)700 23754643)
This document relates to the following versions:
• Ikus software: from V 3.40 RC0029
• Laptop software: from V 3.40V
• Laptop from CF27
Approval and conformity declaration
Manufacturer
Berlin Heart GmbH
Wiesenweg 10
12247 Berlin
Imprint
© January 2008
Berlin Heart GmbH
Wiesenweg 10
12247 Berlin
All rights reserved.
This handbook may not, in full or in part, be reproduced, sent, transmitted in an electronic
medium, stored in a data processing system or translated into another language without the
written consent of Berlin Heart GmbH.
This handbook is intended for information purposes only. The contents of this handbook may
be expanded, modified or updated at any time without notification.
Previous versions of the instructions for use become invalid with the publication of this version.
All translations of this handbook were performed and checked to the best of our knowledge and
belief. However, only the German and English editions of this handbook are valid as the legally
binding versions.
Licenses, trademarks and brand names
EXCOR ® , INCOR ® and are brands / trademarks of Berlin Heart GmbH.
They are protected in Germany and other countries.
All other trade names mentioned in this handbook are subject to the rights of their respective
owners. These rights are expressly recognized and respected wherever these names are used in
this publication.
Text and design
Berlin Heart GmbH
The EXCOR ventricular assist device (UMDNS number: 10-847) fulfils the
requirements of Guideline 93/42/EWG for Class 3 medical device. The
entire EXCOR system including the Ikus and all consumable materials
have carried the CE mark since 1996.
1000002 Rev. 4.9.1 i

ii 1000002 Rev. 4.9.1

Table of contents
1 Important safety information 3
1.1 Conditions of use..................................................................................................................................................3
1.2 Handling................................................................................................................................................................3
1.3 Risks and adverse effects......................................................................................................................................4
1.4 Combination with other products/procedures....................................................................................................4
2 General product information 5
2.1 Use in accordance with the intended applications..............................................................................................5
2.2 Indications.............................................................................................................................................................5
2.3 Contraindications..................................................................................................................................................5
2.4 Possible objectives of the therapy ........................................................................................................................5
2.5 Manufacturer’s warranty.......................................................................................................................................5
2.6 Operator obligations.............................................................................................................................................6
2.7 Packaging and sterility ..........................................................................................................................................6
2.8 Transportation and storage ..................................................................................................................................6
2.9 Maintenance..........................................................................................................................................................7
2.10 Disposal.................................................................................................................................................................7
3 Description: Blood pump, cannulas, accessories 9
3.1 EXCOR blood pumps............................................................................................................................................9
3.2 EXCOR cannulas .................................................................................................................................................10
3.3 EXCOR accessories.............................................................................................................................................11
4 Description: Stationary Driving Unit Ikus 13
4.1 Overview..............................................................................................................................................................13
4.2 Displays and operating elements.......................................................................................................................14
4.2.1 Connection panel ..........................................................................................................................................14
4.2.2 Display and operating panel .........................................................................................................................15
4.3 Power supply .......................................................................................................................................................15
4.4 Operating modes ................................................................................................................................................16
4.4.1 Univentricular mode......................................................................................................................................16
4.4.2 Biventricular mode ........................................................................................................................................16
4.5 Laptop with monitoring program.......................................................................................................................16
4.6 Safety ...................................................................................................................................................................17
4.6.1 Fall-back redundancy of pneumatic systems for univentricular mode .......................................................17
4.6.2 Fall-back redundancy of pneumatic systems for biventricular mode..........................................................17
4.6.3 Control processor design with fall-back redundancy...................................................................................17
1000002 Rev. 4.9.1 iii

4.6.4 Battery mode..................................................................................................................................................17
4.6.5 Manual pump ................................................................................................................................................17
4.6.6 Password-protected user profiles (entry code) ............................................................................................18
5 Instructions for use: Ikus 19
5.1 Start menu ...........................................................................................................................................................19
5.1.1 Select options from the start menu ..............................................................................................................19
5.1.2 Add/ change/ delete entry code....................................................................................................................20
5.1.3 Save data to floppy ........................................................................................................................................20
5.1.4 Change date/time ..........................................................................................................................................20
5.2 Fundamentals of the monitoring program ........................................................................................................21
5.2.1 Starting the monitoring program .................................................................................................................21
5.2.2 Ending the monitoring program ..................................................................................................................21
5.2.3 Logging on and off from the monitoring program.......................................................................................21
5.2.4 Normal view of monitoring program ...........................................................................................................22
5.2.5 Select options in the monitoring program ...................................................................................................23
5.2.6 Adjust the parameter values .........................................................................................................................23
5.2.7 Scroll through the message window.............................................................................................................24
5.3 Stop the blood pumps, switch off the Ikus ........................................................................................................24
5.3.1 Drive pause: Stop the Ikus temporarily ........................................................................................................25
5.3.2 Pause left/Pause right: Stop individual blood pumps (and switch them off if necessary).........................25
5.3.3 Drive off: Switch off the Ikus .........................................................................................................................25
5.4 Switching between mains power and battery mode ..........................................................................................26
5.5 Switching from univentricular to biventricular mode ........................................................................................27
5.6 Routine start test in the event of non-use ..........................................................................................................28
5.7 Moving the Ikus...................................................................................................................................................29
5.8 Packaging and transport .....................................................................................................................................29
6 Start up the Ikus and set the parameters 31
6.1 Preparations outside of the operating room......................................................................................................31
6.1.1 Connecting the vessel model ........................................................................................................................32
6.1.2 Switch on the Ikus .........................................................................................................................................32
6.1.3 Starting the monitoring program..................................................................................................................32
6.1.4 Setting the test parameters ...........................................................................................................................33
6.2 Intraoperative drive management ......................................................................................................................33
6.2.1 Disconnect the vessel model from the Ikus .................................................................................................33
6.2.2 Select the operating mode (“Operating mode” view)..................................................................................34
6.2.3 Selecting the pump size ................................................................................................................................34
6.2.4 Setting the startup parameters .....................................................................................................................35
iv 1000002 Rev. 4.9.1

6.2.5 Connect the blood pump(s) to the Ikus .......................................................................................................35
6.2.6 De-air the pump(s) in single-step mode ......................................................................................................36
6.2.7 Start the pump (switch to normal view).......................................................................................................36
6.2.8 Check and adjust the parameters when the pump is started......................................................................36
6.2.9 Switching from HLM to VAD ........................................................................................................................38
6.2.10 Possible complications .................................................................................................................................39
6.3 Postoperative drive management.......................................................................................................................40
6.3.1 After transfer to the ward ..............................................................................................................................40
6.3.2 After further progress....................................................................................................................................40
7 Implantation: Preparation in the operating room 41
7.1 Preparing the components and materials..........................................................................................................41
7.2 Unpacking the sterile components ....................................................................................................................41
7.3 Atrial cannulas with mandrin: Prepare the cannula...........................................................................................41
7.4 Pump with PU valve............................................................................................................................................42
7.5 Pump with tilting-disk valve................................................................................................................................42
7.6 De-air the pump ..................................................................................................................................................43
8 Implantation – Surgical procedure 45
8.1 Access..................................................................................................................................................................45
8.2 Apex cannula(s) ..................................................................................................................................................45
8.2.1 Anastomosing the apex cannula...................................................................................................................45
8.2.2 Create the transcutaneous passage for the apex cannula ...........................................................................46
8.3 Atrial cannula(s)..................................................................................................................................................47
8.3.1 Creating a transcutaneous passage for atrial cannula(s) ............................................................................47
8.3.2 Anastomize the inflow cannula(s) with an atrium.......................................................................................47
8.4 Outflow cannula(s) .............................................................................................................................................48
8.4.1 Creating transcutaneous passages for outflow cannula(s) .........................................................................48
8.4.2 Anastomosing the outflow cannula(s) .........................................................................................................49
8.5 If necessary: Shorten the cannulas.....................................................................................................................49
8.6 Connect the pumps to the cannulas ..................................................................................................................50
8.7 Remove the de-airing needle ..............................................................................................................................51
8.8 Secure the connections.......................................................................................................................................51
8.9 Anesthesia ...........................................................................................................................................................51
8.9.1 Intraoperative anticoagulation therapy.........................................................................................................52
8.10 After the operation ..............................................................................................................................................52
9 Intensive care and aftercare 53
9.1 Postoperative anticoagulation therapy...............................................................................................................53
1000002 Rev. 4.9.1 v

9.1.1 Example: Anticoagulation therapy - Adolescents/adults..............................................................................53
9.1.2 Example: Anticoagulation therapy - EXCOR Pediatric..................................................................................54
9.1.3 Monitoring the blood values.........................................................................................................................55
9.2 Postoperative platelet aggregation inhibition therapy.......................................................................................55
9.2.1 Example: Platelet aggregation inhibition therapy - Adolescents/adults......................................................56
9.2.2 Example: Platelet aggregation inhibition therapy - EXCOR Pediatric ..........................................................56
9.3 Antibiotic therapy ................................................................................................................................................56
9.4 Wound care..........................................................................................................................................................56
9.5 Regular inspection of blood pump(s) and cannulas .........................................................................................58
9.5.1 Visual inspection: Filling/ ejecting of the blood pump ................................................................................59
9.5.2 Visual inspection: Deposits...........................................................................................................................59
9.5.3 Inspection via the monitoring program........................................................................................................60
10 Explantation 61
10.1 Bridge-to-Transplant (BTT).................................................................................................................................61
10.2 Weaning (Bridge-to-Recovery, BTR) ...................................................................................................................62
10.2.1 Explantation with univentricular support .....................................................................................................62
10.2.2 Explantation with biventricular assistance/support.....................................................................................62
11 Error messages and corrective action 63
11.1 Batteries discharged; battery mode not possible...............................................................................................64
11.2 Updating the parameter block failed ..................................................................................................................64
11.3 The acoustic alarm is not correctly detected......................................................................................................64
11.4 Alarm circuit fault – horn remains off (or on)....................................................................................................65
11.5 Connect the driving tube.....................................................................................................................................65
11.5.1 Replace the driving tube................................................................................................................................65
11.6 Do not operate the driving unit without supervision!........................................................................................66
11.7 Backup operation left/right.................................................................................................................................66
11.8 Please check the tube and the left/right pump ..................................................................................................66
11.9 Fault: () .............................................................................................66
11.10 Throttle valve error in system 1 (or system 2 or 3), please wait........................................................................67
11.11 Pressure error/ time error in system 1 (or system 2 or 3).................................................................................67
11.12 Backup processor................................................................................................................................................67
11.12.1 ...flow measurement deviation on the left (or right) ....................................................................................67
11.12.2 ...is reporting abnormal measurements on the left (or right) .....................................................................67
11.12.3 ...is reporting the error: Flow measurement on the left (or right)...............................................................68
11.12.4 ...is reporting a checking error ......................................................................................................................68
11.13 FATAL: Battery failure! Inform Service urgently! ................................................................................................68
11.14 Error: no data/no reaction from the control processor .....................................................................................69
vi 1000002 Rev. 4.9.1

11.15 The error is only detected by the active (or passive) controller ........................................................................69
11.16 Left/right flow sensor defective. Contact Service department! .........................................................................69
11.17 No internal communication ...............................................................................................................................70
11.18 Emergency operating mode................................................................................................................................70
11.18.1 Univentricular ................................................................................................................................................70
11.18.2 Biventricular...................................................................................................................................................70
11.19 Problem: .............................................................................................................................................71
11.20 Processor failure. Contact service! .....................................................................................................................71
11.21 The self-test is not ended by the passive processor ..........................................................................................71
11.22 System 1 (or 2) is faulty ......................................................................................................................................71
11.23 System 3 is faulty ................................................................................................................................................72
11.24 System has reached maximum capacity ...........................................................................................................72
11.25 Temperature sensors: .................................................................................................73
11.26 Faulty connection to the laptop..........................................................................................................................73
11.27 Error messages during the start test..................................................................................................................73
11.27.1 Battery mode test skipped due to battery problem......................................................................................73
11.27.2 Faulty connection to the laptop ....................................................................................................................73
11.27.3 Additional messages during the start test ...................................................................................................74
12 Detecting and eliminating problems 75
12.1 Replace the blood pump(s) ................................................................................................................................75
12.1.1 Prepare the replacement blood pump..........................................................................................................76
12.1.2 Replacing a blood pump ...............................................................................................................................76
12.1.3 Replacing the two blood pumps ...................................................................................................................77
12.2 Restart the Ikus ...................................................................................................................................................78
12.3 Emergency pulse mode.......................................................................................................................................79
12.3.1 Emergency pulse mode - Switching off the Ikus ..........................................................................................79
12.3.2 Ikus start test after emergency pulse mode .................................................................................................79
12.4 Connect the patient to the replacement Ikus.....................................................................................................80
12.5 Operate the blood pump(s) with the manual pump.........................................................................................81
12.6 Failure of the power supply or both control processors....................................................................................82
12.7 Read out the log files ..........................................................................................................................................83
12.8 Battery fuse..........................................................................................................................................................83
13 Appendix 85
13.1 Overview: Product range and combination options..........................................................................................85
13.2 Technical specifications......................................................................................................................................89
13.3 Symbols ...............................................................................................................................................................90
13.3.1 Ikus: Identification plate................................................................................................................................90
1000002 Rev. 4.9.1 vii

13.3.2 Ikus: connection panel ..................................................................................................................................90
13.3.3 Marking of Numlock status LED...................................................................................................................90
13.4 EXCOR standard forms implantation record .....................................................................................................91
13.5 Standard form: EXCOR pump log ......................................................................................................................93
13.5.1 Explanations on the pump log ......................................................................................................................93
13.5.2 EXCOR pump log..........................................................................................................................................94
13.6 Standard form: EXCOR parameter log ...............................................................................................................95
13.7 Standard form: EXCOR emergency log ..............................................................................................................96
13.8 Standard form: Blood pump replacement .........................................................................................................98
13.9 Additional information: Laptop Panasonic CF29...............................................................................................99
14 EMC tables 101
14.1 Electromagnetic immunity - Part 1 ...................................................................................................................102
14.2 Electromagnetic immunity - Part 2 ...................................................................................................................103
14.3 Recommended protection distances between wearable and mobile HF telecommunications
devices and the Ikus..........................................................................................................................................104
15 About these instructions for use 105
15.1 The most important changes at a glance.........................................................................................................105
15.2 Explanations ......................................................................................................................................................105
viii 1000002 Rev. 4.9.1

A
Accessories 11, 88
Accessory set 41
for pump with PU valves 88
for pump with tilting-disk valves 11, 88
for pumps with PU valves 11
Adjust the
operating mode 37
parameter values 23
parameters 36
Adjusting
parameters for cardiac insufficiency 59
parameters for mobilization 59
the parameters 59
Aftercare 53
Alarm circuit
Error message 65
fault – horn remains off (or on) 65
Self-test 21
Alarm, external (nurse call) 4
Ambient temperature
Operation 89
Storage and transport 89
Antibiotic therapy 56
Anticoagulation
Adolescents, adults 53
EXCOR Pediatric 54
Low molecular weight heparin 55
postoperative 53
therapy, intraoperative 52
therapy, preoperative 52
Appendix 85
Asynchronous mode 16, 37
B
Battery fuse 14, 83
in battery mode 84
in mains power operation 83
Battery mode 17, 26
Battery fuse 84
red LED 15
yellow LEDs 15
Bleeding 4
Blood Pump
Implantation 45
Blood pump
Combination with cannulas 87
Corrective action to be taken in the case of poor filling
59
De-airing 43
Description 9
EXCOR pump log 59, 94
Explantation 61
Filling, optimal 59
Implantation 41
Membrane set 42
Pressure gauge set 43
PU valves 85
Single-step mode 36
Storage 6
Tilting-disk valves 85
Titanium connector 10
Transportation 6
Tube attachment set 88
Visual inspection 59
Blood values, monitoring 55
Bridge-to-Recovery 5, 62
Bridge-to-Transplant 5, 61
BTR, Bridge-to-Recovery 5, 62
BTT, Bridge-to-Transplant 5, 61
C
Cannulas
Apex cannulas 86
Arterial cannulas 86
Atrial cannulas 86
Description 10
Cardiac insufficiency 59
Carmeda® BioActive Surface 6, 10
CBAS see Carmeda® BioActive Surface
Change of dressing 58
Changing the
operating mode 27
Checking the
default standard values 81
log 95
parameters 60, 95
Components 9
Conditions of use 3
Connecting set 88
Contraindications 5
Control processor 13
CT scan 4
Cutting tool 88
INDEX
1000002 Rev. 4.9.1 ix
D
De-airing
cannula 44
hammer 88
Pump 43
set 43, 88
Defibrillator 4
Deposits 59
Destination therapy 5
Diathermy 4
Disconnect the vessel model
from the Ikus 33
to the Ikus 32
Displays 14
Disposable products 5
Disposal 7
Driving pressure 37
Driving tube 88
Connector 9

INDEX
Driving units 88
DT, Destination therapy 5
E
Electro-stimulation therapy 4
EMC 3, 101
Electromagnetic immunity 102, 103
Electromagnetic radiation 3
Emissions characteristics 101
Emergency log 96
Emergency operating mode 17, 70
Emergency pulse mode 79
Entry code: see user profile
Error
during self-test 33
during start test 73
Error messages
Alarm circuit fault – horn remains off (or on) 65
Backup operation left/right 66
Batteries discharged; battery mode not possible 64
Connect the driving tube 65
Do not operate the driving unit without supervision!
66
Emergency operating mode 70
Emergency operating mode due to empty batteries -
threat of total failure! 70
Error : no data⁄ no reaction from the control processor
69
Error during start test 73
FATAL: Battery failure! Inform Service urgently! 68
Fault: () 66
Faulty connection to the laptop (during start test)
73
Faulty connection to the laptop (outside of the start
test) 73
Left/right flow sensor defective. Contact Service department!
69
No internal communication 70
Please check the tube and the left/right pump 66
Pressure error/time error in the system 67
Processor failure. Contact service! 71
System 1 (or 2) is faulty 71
System 3 is faulty 72
The acoustic alarm is not correctly detected 64
The error is only detected by the active (or passive)
controller 69
The self-test is not ended by the passive processor
71
Throttle valve error in the system 67
Updating the parameter block failed 64
Exiting the
monitoring program 21
Explantation 61
External alarm (nurse call) 14
F
Failure of the control processors 82
Failure of the power supply 82
H
Hemolysis 4
I
Identification plate 90
Ikus
Commissioning 31
Connection panel 14
Description 13
emergency log 96
Instructions for use 19
Overview 13
Preparation outside of the operating room 31
Routine start test
Single-step mode 36
Storage 6
Transport 29
Transportation 6
Implantation 41, 45
EXCOR implantation record 91
Intraoperative drive management 33
Implantation record 91
Indications 5
Infections 4
Information message: System has reached maximum
capacity 72
Inspection
Monitoring program 60
Parameter 60
Pump filling 59
Pump, deposits 59
Intensive care 53
K
Key switch (main switch; O/I) 14
L
Laptop 13
see also monitoring program
Log file 63
Logging the
parameters 60
x 1000002 Rev 4.9.1
M
Magnetic resonance imaging 3, 4
Main switch (key switch; O/I) 14
Mains power 3, 15, 27
Mains power operation
Battery fuse 83
Maintenance 7
Manual pump 17, 81
Maximum capacity 72
Membrane set 42, 88
Message window 22, 24

Messages
The error is only detected by the active (or passive)
controller 69
Mobilization of patient 59
Monitoring
Blood values 55
Monitoring procedure 51
Monitoring program 13, 16
Adjust the parameter values 23
Drive off 25
Drive pause 25
Fundamentals 21
Logging users on and off 21
Message window 22, 24
Parameter table 22
Pause left/Pause right 25
Pressure graph 22
Pump size and single-step mode 35
Select options 23
Moving
the Ikus 29
Multiorgan failure 5
N
Nuclear diagnostics 4
Nuclear therapy 4
Numlock 19
Marking of status LED 90
Nurse call (external alarm) 4, 14
O
Objectives of the therapy 5
Obturator 44
Operating mode 16
Asynchronous mode 16, 37
biventricular 16
Separate pulse 16, 38
Synchronous mode 16, 37
univentricular 16
Operation, after the 52
Operator obligations 6
P
Packaging 6, 29
Packing
the Ikus 30
Parameter
Startup parameters 35
table 22
Target values for normal operation, recommended
38
Test parameters 33
Platelet aggregation inhibition therapy
Adolescents, adults 56
EXCOR Pediatric 56
Potential equalization 14
Power supply 15
INDEX
Battery mode 15
Mains power 15
red LED 15
Switching between mains power and battery mode
26
yellow LEDs 15
Power switch (mains power switch) 14
Pressure error 67
Pressure gauge 88
Pressure gauge set 43, 88
Pressure graph 22
Pressure vessel 32
Product range 85
Pump log 94
Pump size and single-step mode 35
Pump: see blood pump
R
Radiotherapy 4
Replace the
blood pump 75
driving tube 65
Replacing the blood pump
, standard form 98
Risks and adverse effects 4
Routine start test: see start test
1000002 Rev. 4.9.1 xi
S
Self-test of the alarm circuit 21
Separate pulse 16, 38
Sepsis 5
Signs of infection 5
Single-step mode 36
Special range 88
Standard form
EXCOR emergency log 96
EXCOR implantation record 91
EXCOR parameter log 95
EXCOR pump log 94
Standard form: Replacing the blood pump 98
standard values, default 81
Start test
after emergency pulse mode 79
Error messages 73
Routine test
Start the
blood pump 36
Starting the
monitoring program 21
Startup parameters 35
Sterility 6, 41
Stop the
blood pump 24
Storage 6
Suction pressure 37
Synchronous mode 16, 37
System accessories 88

INDEX
System has reached maximum capacity 72
T
Technical specifications 89
Tensile stress relieving belt 88
Test parameters 33
Thrombo-embolic complications 4
Throttle valve error 67
Time error 67
Transplant 5
Transport crate 29
Transportation 6, 29
Trocar 44
Tube attachment set 88
U
Ultrasonic treatment 4
Univentricular mode 16
Use in accordance with the intended applications 5
User profile, preset 20
W
Warranty 5
Weaning 62
Wound care 56, 58
X
X-rays 4
xii 1000002 Rev 4.9.1

Dear Reader,
These instructions for use are intended for all people involved in the support and care of
patients with an EXCOR VAD (called ‘EXCOR’ for short below).
These instructions for use contain information about the setup, functionality and use of
the EXCOR VAD with the EXCOR Ikus inpatient driving unit (called ‘Ikus’ for short
below). To ensure the safety of your patient, please read these instructions for use
carefully.
Always ensure that only technical medical personnel who have received product-specific
training are permitted to work with EXCOR.
The following symbols are used in these instructions for use:
Warning!
• Disregarding these symbols puts the health of your patient and risk and may result
in death.
Caution!
• Disregarding these symbols may also cause the EXCOR to be destroyed.
Note
• Additional information is flagged by this symbol.
Instructions
1. The procedural steps are consecutively numbered.
Recommendation
• This logo designates measures and working methods that have proven effective in
relation to EXCOR and that we therefore recommend.
Notify hotline! +49(0)30 8187 2772
Call this hotline number to contact the relevant service department. Operators are on
the line 24 hours a day. This number connects you to the clinical personnel and is
exclusively intended for emergency use.
Call +49 (0)30 8187 2600 to contact Berlin Heart GmbH. Here you can find answers to
your questions relating to EXCOR.
1000002 Rev. 4.9.1 1

2 1000002 Rev. 4.9.1

1 Important safety information
1.1 Conditions of use
Warning!
• Only technical medical personnel who have received product-specific training are
permitted to work with EXCOR.
• Before the initial startup of Ikus, always check whether a replacement Ikus or Berlin
Heart GmbH service is available within 24 hours.
• Only connect the Ikus to mains outlets with protective earth contacts with the voltage
indicated on the Ikus identification plate. Only connect the Ikus to mains outlets with
protective earth contacts that correspond to your country-specific requirements.
• During operation, connect the Ikus via the potential equalization connection to the fixed
protective earth.
• Protect the Ikus against humidity and moisture. Never store the Ikus in damp areas
(bathrooms, etc.).
• Do not use the Ikus in an environment where flammable gases are present.
• The Ikus is subject to special precautionary measures with respect to EMC. Avoid
exposing the Ikus to strong electromagnetic radiation (switched-on cellular phones or
cordless phones, magnetic resonance imaging, etc.). See also Chapter 14: "EMC tables",
p. 101.
• If an ambient temperature of 30°C is exceeded in operation, the service life of the
batteries is reduced. Therefore, a second person should always be present in this case.
Caution!
• Protect the Ikus against temperatures below +10 °C and above +30 °C, temperature
fluctuations (e.g. sunshine, heating) and heat accumulation.
Note
• See also “Technical specifications” on page 89.
1.2 Handling
Warning!
• Only use the supplied connecting cables, plug and components.
• The power switch (mains power switch) on the Ikus must always be on ON/EIN - even
when the Ikus is running in battery mode or is switched off. Otherwise, there is a risk of
failure of the driving unit due to completely discharged batteries. The only exception is
battery mode: before switching to battery mode, move the power switch (mains power
switch) to the OFF/Aus [O] position. Immediately after restoring the power connection,
move the power switch back to the ON/Ein [I] position.
• The Ikus is designed to be run on mains power and in stationary operation. Only run it
in battery mode when this is absolutely necessary (e.g. when transporting the patient).
Important: In order to prevent rapid aging of the batteries, the Ikus should always be run
for at least 6 hours on mains power, after being run in battery mode. Disregarding this
step will severely impair the battery capacity and will severely reduce the maximum offmains
operating time. Always pay attention to the charge status indicator.
• Whenever the Ikus is running in battery mode, the patient must be accompanied by a
person who has been trained to use the manual pump.
• Ensure that cannulas, blood pump(s) and driving tubes are positioned so that they are
free of tension and kinks. Prevent the cannulas and connectors from being exposed to
traction forces.
• Do not touch the blood pumps and cannulas with pointed or sharp-edged objects
(surgical instruments, wire brushes, etc.).
• At least three times a day, visually check that the blood pump(s) is (are) filling and
ejecting completely over several pump cycles. If a blood pump is not filling and/or
ejecting completely, take appropriate corrective action.
Conditions of use
1000002 Rev. 4.9.1 3

Risks and adverse effects
Important safety information
• Whenever an error message occurs, visually check over several pump cycles that each
blood pump is filling and emptying completely. Take action according to the error
message.
Caution!
• Protect the Ikus against dirt. Prevent foreign objects falling inside the connectors and air
vents. Keep all driving tube connectors covered at all times when not in use.
• To clean the components, especially the driving tubes, only commercial disinfectants
appropriate for plastic materials must be used. Do not place the components in contact
with any chemicals other than those used for disinfection.
• Moving the Ikus: Only push the Ikus using the handle provided for this purpose. Avoid
jerky motions.
• Lifting the Ikus: Use only the lifting bars located on the lower edge at each side of the
Ikus. Never lift the Ikus by its handle.
Precautionary measures
• After switching on the Ikus, pull the key out of the main switch and store it in a safe place.
• Connect the external alarm (nurse call) to the Ikus.
• Place the Ikus on a stable, level surface. Never place the Ikus on surfaces with an incline
of more than 10% (danger of tipping over!).
• Do not place or lay anything on top of the Ikus.
1.3 Risks and adverse effects
The following possible complications are known:
• Bleeding
• Thrombo-embolic complications
• Infections
• Hemolysis
1.4 Combination with other products/procedures
Combination is not possible
• Magnetic resonance imaging
Combination only after consultation with the attending physician
• Radiotherapy
• Nuclear diagnostics/ Nuclear therapy
• Electro-stimulation therapy
• Therapeutic ultrasonic treatment (e.g. lithotripsy)
• Diathermy
• Extern defibrillator
• X-rays
• CT scan
4 1000002 Rev. 4.9.1

2 General product information
2.1 Use in accordance with the intended applications
2.2 Indications
Use in accordance with the intended applications
EXCOR is a ventricular assist device designed for human use. It can be used for
univentricular (LVAD or RVAD) or biventricular support. Atrial or ventricular cannulation
is possible.
EXCOR must only be operated with EXCOR components (see page 88) and with
observance of the indications, contraindications and instruction manual.
EXCOR with Ikus is designed exclusively for stationary use in a clinic. In patients who
show stable hemodynamic parameters and are supported by blood pumps of the sizes
60 ml and/or 80 ml, Ikus can be replaced by EXCOR mobile driving system Excor.
In doing so, the indications, contraindications and intended applications of EXCOR
mobile driving system Excor must be observed.
The EXCOR blood pumps and EXCOR cannulas are disposable products.
Acute or chronic, conservatively uncontrollable cardiac insufficiency of different genesis
in stages III or IV according to NYHA with an expected short-term to long-term support
requirement.
2.3 Contraindications
• Signs of infection which do not correspond to a sepsis-like syndrome
• Sepsis
• Advanced multiorgan failure
2.4 Possible objectives of the therapy
Bridge-to-Transplant (BTT)
In patients who are already listed for a transplant and for whom a conservative
medication-based treatment is no longer possible, the system can bridge the waiting
time until the transplant.
Bridge-to-Recovery (BTR)
By means of relief, the myocardium should be able to recover to the extent that the
EXCOR VAD can be explanted after the individual treatment duration.
Destination therapy (DT)
In patients for whom a contraindication to transplant exists, a long-term, open-end
mechanical circulatory support should be achieved.
2.5 Manufacturer’s warranty
• EXCOR blood pumps: Max. duration of use: 500 days; recommended duration of use:
one year
• EXCOR cannulas: With appropriate treatment, no time restriction
• Batteries: six months
• Ikus, with exception of the batteries: If the prescribed maintenance cycles are observed,
two years
The warranty is valid only when it is stored as prescribed and used as directed, and when
the packaging is intact. This applies in particular to all sterile packages as well as the
aluminum-coated outer packaging of the blood pump.
If an ambient temperature of 30 °C is exceeded in running operation, the maintenance
interval is reduced to 3 months.
1000002 Rev. 4.9.1 5

Operator obligations
General product information
The warranty claim is invalidated if the Ikus is opened by anyone other than the service
personnel of Berlin Heart GmbH or people authorized by Berlin Heart GmbH service.
The general business conditions of Berlin Heart GmbH apply.
2.6 Operator obligations
Only qualified, technical medical personnel who have received product-specific training
may work with EXCOR. Training sessions by appointment.
The operator is responsible for informing and caring for the patient.
The operator is entrusted with ensuring the observance of the prescribed maintenance
intervals (see “Maintenance” on page 7).
If damage arises in a component, Berlin Heart GmbH service must be informed
immediately.
The patient must be informed about the safety risks and precautionary measures
(relating to humidity, temperature, electromagnetic fields, etc.).
The Ikus must only be operated with the components mentioned in this document. The
Ikus must not be operated with multi-outlet power strips or extension cords.
2.7 Packaging and sterility
EXCOR blood pumps and cannulas are disposable products and are not intended
for reuse.
The sterile parts are sterilized with ETO and packaged in a double sterile package. Before
opening the sterile package, its intactness must be checked. Sterile parts with damaged
sterile packaging must not be used. This also applies to sterile parts which have
exceeded the imprinted expiration date.
An aluminum-coated outer packaging protects the Carmeda ® coating (CBASTM ) of the
sterile-packaged blood pump against fluctuations in air humidity. Blood pumps with
damaged outer packaging must not be used.
The following articles are delivered in a sterile state: Blood pumps, cannulas, pressure
gauge set, de-airing set, de-airing hammer, tube attachment set.
The outer packaging and the external sterile package are nonsterile and must be
removed before handing over to a sterile person.
2.8 Transportation and storage
Transportation
To transport the Ikus, only the supplied original transport crate must be used. Ensure
that the Ikus is placed firmly and securely inside the transport crate and that the case is
correctly closed.
The case may only be transported as shown. Do not tilt or overturn the Ikus when it is
packed inside the transport crate.
Caution!
• Always observe a resting period of six hours after each transportation before switching
on the Ikus!
Note
• See also Chapter 5.8 “Packaging and transport” on page 29.
6 1000002 Rev. 4.9.1

Storage
EXCOR components must be stored at room temperature (20 °C to 25 °C). An increase
in the temperature up to 40 °C for a maximum of 24 hours is permitted. The components
must also be protected against direct sunlight, temperature fluctuations and humidity.
Caution!
• When the Ikus is not used, start it up for 24 hours each month to ensure that all the
batteries (especially the laptop batteries) are sufficiently charged, and perform the selftest
(see Section 5.6 “Routine start test in the event of non-use” on page 28).
2.9 Maintenance
2.10 Disposal
Ikus: When not in operation, every six months; when in operation, every 2000 hours.
The operator is responsible for ensuring the observance of the prescribed maintenance
intervals.
If an ambient temperature of 30 °C is exceeded in running operation, the maintenance
interval of the batteries is reduced to 3 months or 1000 hours.
Repairs and maintenance must only be performed by Berlin Heart GmbH service or by
people authorized by Berlin Heart GmbH service for this purpose. Therefore, the
instructions for use contain no circuit diagrams.
Only manufacturer-approved spare parts may be used for maintenance and repairs.
Berlin Heart GmbH will accept blood pumps, Ikus and accessories for specialized
disposal. The cannulas may be disposed of by the clinic. The material of the cannulas
requires no special disposal measures.
Maintenance
1000002 Rev. 4.9.1 7

Disposal
General product information
8 1000002 Rev. 4.9.1

3 Description: Blood pump, cannulas, accessories
EXCOR blood pumps
EXCOR VAD is an extracorporeal, electro-pneumatically driven ventricular assist device.
It can be used for both univentricular and biventricular heart support. EXCOR VAD
consists of the following permanently active components:
• Extracorporeal blood pump(s)
• Inflow and outflow cannula(s)
• 1 driving tube per blood pump
• 1 Driving Unit Ikus
Cannula
Blood pump
Driving tube
EXCOR in situ; here as biventricular support for pediatric use
Overview
The blood flows from the atrium or ventricle through the inflow cannula into the blood
chamber of the pump and from there through the outflow cannula into the aorta or
pulmonary artery. A driving tube connects the air chamber of the pump with the electropneumatic
driving unit of the Ikus. The Ikus provides the suction and driving pressures
that move the triple-layer membrane between the air and blood chambers of the pump.
3.1 EXCOR blood pumps
h
g
e
i
a
c b
Blood pump 60 ml, here with PU valves
f
d
Driving Unit Ikus
a Air chamber
b Driving tube connector
c Triple-layer membrane
d Blood chamber (de-airing nipple on the back)
e Arrow: points in the blood flow direction
f Inflow stub
g Outflow stub
h Titanium connector: Outflow stub - Outflow
cannula
i Titanium connector: Inflow stub - Inflow cannula
1000002 Rev. 4.9.1 9

EXCOR cannulas
Description: Blood pump, cannulas, accessories
EXCOR blood pumps consist of a transparent polyurethane (PU) housing divided by a
flexible triple-layer membrane into a blood chamber and an air chamber.
From the blood chamber, an inflow or outflow stub lead to an inflow or outflow cannula.
The stubs themselves consist of PU. At their ends, there are titanium connectors to
which the cannulas are attached. Mechanical valves in the stubs guarantee a targeted
blood flow. EXCOR blood pumps are available with tilting-disk valves (50 - 80 ml stroke
volume) or trileaflet valves made from polyurethane (10 - 80 ml stroke volume).
The blood contact surface of the pump is coated with Carmeda ® BioActive Surface
(CBASTM ). The transparent housing of the blood pump permits easy visual inspection,
so that the filling and emptying and the status of the blood chamber can easily be
monitored.
By means of the de-airing nipple in the blood chamber, the pump is de-aired during
commissioning with the aid of the de-airing set.
The air chamber of the pump is equipped with a driving tube connector. This connects
to the air-conducting driving tube that links the pump to the Driving Unit Ikus. With
suction and driving pressures, the Ikus actuates the triple-layer membrane of the blood
pump. To minimize friction, there is graphite powder between the individual
membranes.
3.2 EXCOR cannulas
For EXCOR, three cannula types in three different sizes are offered:
• Atrial cannulas (inflow cannulas)
• Apex cannulas (inflow cannulas)
• Arterial cannulas (outflow cannulas)
The cannulas consist of tissue-friendly silicon. Suture rings made from polyester velour
permit fast and safe anastomosis of the cannulas. The midsection of every cannula is
sheathed with polyester velour to ensure good inward movement of the cannula.
Some arterial cannulas possess a flexible metal reinforcement that permits the
adjustment of the cannulas to the anatomical conditions.
Some atrial cannulas are delivered with a mandrin.
1 2 3
Cannula heads: 1) Atrial cannula, 2) apex cannula, 3) arterial cannula
10 1000002 Rev. 4.9.1

3.3 EXCOR accessories
For the commissioning and operation of EXCOR, the following EXCOR accessories are
required:
• One driving tube (PVC) per blood pump
• Accessory set:
T00L-001 for blood pumps with tilting-disk valves
• Pressure gauge set with pressure gauge
• De-airing set (2 x trocar, 2 x de-airing tube)
• De-airing hammer
• Tube attachment set (cable tie strap, cable tie pliers)
T00L-002 for blood pumps with PU valves
• Membrane set
• De-airing set (2 x trocar, 2 x de-airing tube)
• De-airing hammer
• Tube attachment set (cable tie strap, cable tie pliers)
EXCOR accessories
1000002 Rev. 4.9.1 11

EXCOR accessories
Description: Blood pump, cannulas, accessories
12 1000002 Rev. 4.9.1

4 Description: Stationary Driving Unit Ikus
4.1 Overview
The stationary electro-pneumatic Driving Unit Ikus provides driving and negative
pressure for the blood pump(s). The casing of the driving unit contains pneumatic and
electronic components and a laptop as the user interface.
Display and operating panel
Grip
Connection panel
Driving tubes
Stationary Driving Unit Ikus
Laptop with monitoring program
Lifting bars
Power cord
Pneumatic system
Ikus is equipped with three independently functioning pneumatic systems.
One pneumatic system supplies each of the blood pumps, while the third pneumatic
system serves as a backup. Each pneumatic system consists of:
• Compressor
• Pressure and suction limiter
• Pressure and vacuum cylinders
• Control electronics
• Control valves
The compressor, together with the pressure and suction limiters, provides constant
pressure conditions in the pressure and vacuum cylinders. Control valves at the outlet
of each vessel permit the optimal setting of pressure and vacuum parameters.
Control processor
Ikus is equipped with two independently functioning control processors: the active
(primary) control processor and the backup control processor.
Laptop with monitoring program
Messages and pressure graphs in the monitoring program provide information about
the status and functioning of the system. In addition, the laptop is used to start up the
system and adjust the drive parameters. The laptop’s hard drive stores log files
containing system status information.
Manual pump
The manual pump attached to the Ikus can be used temporarily to operate the blood
pump(s) if a functional Ikus is not available.
Overview
1000002 Rev. 4.9.1 13

Displays and operating elements
Description: Stationary Driving Unit Ikus
4.2 Displays and operating elements
4.2.1 Connection panel
Connection panel
1
2 3
8 7 6 5
1. Driving tube connectors, with red and blue markings
2. Battery fuse
3. Mains power indicator: Illuminated in mains power operation (default situation)
4. Power switch (mains power switch)
5. Mains power connector (with plug clip)
6. Main switch (key switch; O/I)
7. Potential equalization connection
8. External alarm connector (nurse call):
A relay circuit connects the internal alarm to the external alarm connector. By default,
this circuit is configured so that, in the presence of an Ikus alarm, this contact is opened
(tap via a 2-pin plug with protective grounding). In this way, an external alarm can be
triggered (nurse call)
Depending on the hospital’s specifications, the configuration of the “External Alarm”
connection can be changed so that the contact is closed in the event of an alarm. This
change to the settings is performed by Berlin Heart GmbH service.
Technical specifications: see page 89.
Main switch (key switch; O/I) and power switch (mains power switch)
The driving unit is turned on and off using the main switch. The main switch can only be
operated with the key.
However, the connection to the mains power supply is only established when the power
switch is also set to ON/EIN. The power switch is a safety measure to protect
against the eventuality of a failure in the mains power supply. If the power switch is set to
OFF/AUS, the Ikus is isolated from the mains power and the batteries come into use
automatically. This discharges the batteries gradually. If the batteries are empty, then the
Ikus will fail. The power switch must therefore always be set to ON/EIN (even in the
switched-off state)! The only exception is battery mode: Before switching to battery
mode, move the power switch (mains power switch) to the OFF/Aus [O] position.
Immediately after restoring the power connection, move the power switch back to the
ON/Ein [I] position.
Warning!
• To prevent inadvertent discharging of the batteries, ensure that the mains power switch
is set to ON/Ein (I) during mains power operation and in the switched-off state.
• During operation, connect the Ikus to the stationary protective ground wire via the
protective earth.
14 1000002 Rev. 4.9.1
4
4
1. Driving tube connectors
2. Battery fuse
3. Mains power indicator
4. Power switch (mains power switch)
5. Mains power connector
6. Main switch (key switch; O/I)
7. Protective earth
8. External alarm connector (nurse call)

4.2.2 Display and operating panel
Display and operating panel
1. Battery operation (battery operation indicator): Illuminated during battery mode.
2. Alarm: Illuminated when there is a message which has not been acknowledged via the
monitoring program.
3. Acknowledge Alarm: Button for acknowledging a message. The acoustic signal stops. The
message remains visible.
4. Counter showing number of operating hours: Number of operating hours elapsed. Flashes
when maintenance is required (after 2,000 operating hours).
Battery charge indicator: Depending on the integrated controller model, 7 or 8 yellow
LEDs show the charge level of the batteries (see below). A red LED shows when the
batteries are completely discharged!
1 2
4.3 Power supply
1. Indicator lamp: “Battery mode”
2. Visual signal display “Alarm”
3. Button: “Acknowledge alarm”
4. Battery charge indicator (above),
counter showing number of
operating hours (below)
1) Battery charge indicator with 7 yellow LEDs, red LED on the left next to the yellow LEDs
2) Battery charge status indicator with 8 yellow LEDs, red LED above the yellow LEDs
The LEDs of the running time display correspond to the maximum possible battery
running time. However, the maximum permitted off-mains operating time is
30 minutes. After 30 minutes of battery operation, a warning message “You must
operate the device on mains power” is displayed. Immediately switch the Ikus over to
mains power operation. Failure to do so may result in damage to the battery system.
Mains power supply with integrated charging unit function (mains power operation)
By default, the Ikus is operated via the mains power supply. During mains power
operation, the batteries which have been completely or partially discharged are
recharged.
During the charging process, the charging status indicator does NOT show the current
charge level. The charging status indicator shows the charge level only when the
batteries have been fully recharged. All of the yellow LEDs light up.
Battery mode
The Ikus contains a battery unit (two batteries with 12 V each) which can supply the
system with power independently for a maximum of 50 minutes. As long as the Ikus is
in battery mode, an acoustic signal sounds once every 10 minutes. If the batteries reach
a low charge level, the acoustic signal sounds once every minute.
Warning!
• The Ikus is designed for stationary operation and supply via the mains power network.
Only use battery mode when it is absolutely necessary (for example, when transporting
the patient). Important: to prevent the batteries from wearing out quickly, every period
of operation in battery mode should be followed by at least 6 hours of mains power
operation. Failure to do this will severely reduce the capacity of the batteries and will
Power supply
1000002 Rev. 4.9.1 15

Operating modes
Description: Stationary Driving Unit Ikus
greatly shorten the maximum off-mains operating time! This particularly applies to
situations where the Ikus is operated at temperatures exceeding 30 °C. Always observe
the charging level display (see page 15)!
• As long as the Ikus is in battery mode, a second person trained in the use of the manual
pump must be constantly present with the patient.
4.4 Operating modes
4.4.1 Univentricular mode
• LVAD
• RVAD
In univentricular mode, the driving tube is connected to the blood pump always (even
RVAD) via the red marked connector.
4.4.2 Biventricular mode
Synchronous mode left/right
Systole of the left and right blood pumps begins simultaneously. The rate is identical for
both pumps and can only be adjusted via the left pump. Systolic pressure, diastolic
pressure and relative systolic duration can be set individually for each blood pump.
Asynchronous mode left/right
The systole of the right blood pump begins when the left pump switches from systole to
diastole. The rate is identical for both pumps and can only be adjusted via the left pump.
Systolic pressure, diastolic pressure and relative systolic duration can be set individually
for each blood pump.
Separate pulse left/right
The two blood pumps are driven independently of each other. All parameters can be
freely set for each pump. The rate of the right pump can be as high as the maximum rate
of the left pump.
4.5 Laptop with monitoring program
The laptop is integrated into the Ikus casing. Via the laptop with the fixed installed
monitoring program, the system is started, and parameters are adjusted and checked.
The running monitoring program provides the user with a constant stream of data about
the system status and information about events and malfunctions. At the same time,
data is stored on the hard drive for later evaluation.
A precise description of the monitoring program can be found in the chapter 5:
"Instructions for use: Ikus", p. 19.
Note
• If the laptop is switched off in running operation, the Ikus continues working with the
currently set parameters.
1 2
1) Laptop, 2) Surface monitoring program
16 1000002 Rev. 4.9.1

4.6 Safety
4.6.1 Fall-back redundancy of pneumatic systems for univentricular mode
A pneumatic system supplies the blood pump. The two other systems act as
redundancies. If the active system fails, then the backup system supplies the pump.
From then on, a system is available as a redundancy.
4.6.2 Fall-back redundancy of pneumatic systems for biventricular mode
Two pneumatic systems each supply one blood pump. The third system acts as a
redundancy. If one of the active systems fails, then the third (backup) system supplies
the corresponding pump. The performance of the Ikus remains completely unaffected.
If two systems fail, then the remaining pneumatic system supplies both pumps. In this
case, the Ikus runs in emergency operating mode.
Emergency operating mode
If two pneumatic systems fail in biventricular mode, then the remaining system supplies
both blood pumps. The Ikus then operates in synchronous mode with 250 mmHg
systolic pressure, - 100 mmHg diastolic pressure, 70 beats per minute and a relative
systolic duration of 40%.
Redundancy of the pneumatic systems in biventricular mode
4.6.3 Control processor design with fall-back redundancy
The control processors also have a redundant design. The Ikus is equipped with two
independently functioning control processors. The main processor controls the
pneumatic systems and transfers functionally important data to the laptop. The backup
control processor constantly compares its calculation results with those of the main
processor. Any differences result in an error message. For safety reasons, the control
processors are housed inside the Ikus casing and work independently from the laptop.
Emergency pulse mode
The emergency pulse circuit board is the final safety system in the electronics. If both
computers fail, it assumes control. To largely eliminate error sources, the emergency
pulse circuit board functions autonomously and cannot be influenced by either the two
computers or the laptop.
In emergency pulse mode, the Ikus works with the following settings: Synchronous
mode (biventricular), systolic pressure 200 mmHg, diastolic pressure - 40 mmHg, rate
90 bpm, relative systolic duration 40%.
4.6.4 Battery mode
4.6.5 Manual pump
If the mains power supply fails, the batteries supply the system with power for at least
50 minutes. The battery operation indicator lights up. Every ten minutes, an acoustic
signal sounds. Every ten minutes, a new message in the monitoring program reports the
time already elapsed in battery mode. The LEDS in the grip area show the charge status
of the batteries.
The supplied manual pump (also BVAD) can be used temporarily to operate the blood
pump if a functional Ikus is no longer available; see page 81.
Safety
1000002 Rev. 4.9.1 17

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

Start menu
Instructions for use: Ikus
5.1.2 Add/ change/ delete entry code
Instructions
1. When the monitoring program is running: exit the monitoring program with .
2. In the start menu, select “Add/ change/ delete entry code”().
3. Enter the default user profile, then confirm with . You are now in the entry code
program.
4. Move the cursor with the vertical arrow keys to the desired user number (↓/↑), then
confirm with .
5. Enter the password, then confirm with .
6. Repeat the entry, then confirm with .
7. If necessary, repeat steps 3 to 5 to set additional user profiles.
8. Confirm all the settings together with . The user numbers are now allocated to the
passwords. You then return to the start menu.
9. In the start menu, select the option “Start program”() to return to the monitoring
program.
10. Enter the user number and password, then confirm with .
Note
• A user profile (entry code) is required to perform the default operating actions in the
monitoring program.
• The default user profile (user ID with password) is required to administer the user profiles.
Additional options in the entry code program
Key Action
ESC Reject entries not yet confirmed with , end the entry code program
ENTF Delete the selected users (confirmation with )
5 Bring up help
5.1.3 Save data to floppy
Additional options in the entry code program
Note
• This option should only be used after consulting with Berlin Heart GmbH service. See
Section 12.7 “Read out the log files” on page 83.
5.1.4 Change date/time
Instructions
1. When the monitoring program is running: Exit the monitoring program with .
2. In the start menu, select “Change date/time”.
3. Move the cursor with the ← / → keys to the desired number.
4. Adjust the value with ↓/↑ (+/-1), then confirm with .
Additional options in the program Change date/time
Key Action
Toggle between the date or time entry fields
Save and end
ESC Abort and return to the start menu
20 1000002 Rev. 4.9.1

5.2 Fundamentals of the monitoring program
5.2.1 Starting the monitoring program
Instructions
1. You are now at the start menu. Select the option “Start program”().
2. Enter the user number and password, then confirm with .
5.2.2 Ending the monitoring program
Fundamentals of the monitoring program
Warning!
• Only end the monitoring program when it is absolutely necessary (for example, to set
new user profiles)! Then restart it again as soon as possible!
Instructions
1. Press and confirm the decision in the dialog window with or . The start
menu appears. The monitoring program is ended.
Note
• When the monitoring program ends
• the system continues operating with the set parameters.
• no actual events are stored; the log files are incomplete.
• the acoustic signal and the indicator lamp on the grip refer to messages. There is
no way to determine the nature of the message.
5.2.3 Logging on and off from the monitoring program
To select options in the monitoring program, to adjust parameters or to scroll through
the message window, you must log on to the monitoring program as a user.
If there is no entry for several minutes, the monitoring program logs the user off
automatically. The Ikus then continues operating with the current settings. The normal
view is then visible.
Note
• Automatic logoff does not occur on the first logon during commissioning of the Ikus.
• On each logon procedure, the Ikus performs a self-test of the alarm circuit. If the selftest
is completed successfully, the message Acoustic alarm: OK appears a few seconds
later. OK. Important: The self-test does not occur if, at the time of logon, an alarm exists
which was acknowledged with the Acknowledge alarm key.
• If a problem arises during the self-test of the alarm circuit, the acoustic signal is
extended for test purposes and cannot be acknowledged during this phase.
Acknowledgment is only possible when a message appears (Alarm circuit defective - horn
remains off! or Acoustic alarm is not correctly detected).
Logon
Instructions
1. You are now in the monitoring program. The monitoring program shows the field “User
ID”. Enter the user number and password, then confirm with . The monitoring
program shows the field “Log off”. You are logged on to the monitoring program.
Log off
Instructions
1. Select “Log off”, then confirm with . The monitoring program shows the field
“User ID”. You are logged off the monitoring program. Further entries are only possible
after logging on again.
1000002 Rev. 4.9.1 21

Fundamentals of the monitoring program
Instructions for use: Ikus
Cautionary measure
• For the safety of your patient, log off the monitoring program before you leave the system.
5.2.4 Normal view of monitoring program
Normal view of the monitoring program during the start test
[A]: Parameter table: The currently set parameters are displayed and can be changed.
[B] Pressure graphs: Graphical illustration of the pressures reached in the pneumatic
system in question.
[C]: Message window: Information about the status of the system (e.g. test operation) and
messages (error messages and cancellation messages; see Section 11 “Error messages
and corrective action” on page 63).
Functions of the monitoring program
• Supervise and control the system
• If necessary: Adjust the parameters
• systolic pressure
• diastolic pressure
• Rate
• relative systolic duration
• biventricular: Operating mode (synchronous mode; asynchronous mode;
separate pulse left/right)
• Inspect messages
• Acknowledge messages
Note
• The displayed pressure graphs relate to the pneumatic pressures generated internally in
the system and correspond to millimeters of mercury [mmHg]. They do not show the
blood pressure of the patient and cannot take the place of diagnostic steps performed
by the medical personnel.
• The monitoring program contains two other views. However, these views only appear on
starting the Ikus or can be brought up via the option “Drive pause” (see page 27/
page 32):
• “Operating mode” view
• “Pump size and single-step mode” view
22 1000002 Rev. 4.9.1
A
B
C

5.2.5 Select options in the monitoring program
Instructions
1. Move the cursor with ← / → to the desired field. A popup menu appears.
Fundamentals of the monitoring program
from left to right: gray border: field is inactive; black/red border: field is active; colored underneath:
field is selected
Note
• The cursor is moved only with ← / → to all fields. To change the line, press one of the
← / → keys repeatedly.
Selecting options in popup menus
Instructions
1. Move the cursor with ↓/↑ to the desired field. All of the possible options for this field are
displayed.
2. Popup menus in the parameter table: Confirm the selection with .
3. Popup menu Pump size: After selecting the size, exit the field with ← / →. The popup
menu is closed, and the selected option is displayed.
Popup menu “Select pump size”
5.2.6 Adjust the parameter values
Instructions
1. Move the cursor with ← / → to the desired field in the parameter table. The active field
is colored underneath.
2. Adjust the value with ↓,↑/ / , then confirm with . The system
works with the new value.
3. Check by visual inspection over several pump cycles that each blood pump is filling and
emptying completely!
1000002 Rev. 4.9.1 23

Stop the blood pumps, switch off the Ikus
Instructions for use: Ikus
Note
• If the adjusted parameter value is not confirmed with , then the parameter table
shows the changed value, but the Ikus continues working with the original value. With
, you can discard the changed parameter display. The original value reappears in
the parameter table. With , you can confirm the change; the adjusted value is
displayed in the parameter table.
Parameter table
Parameter possible range
Adjust the parameters
5.2.7 Scroll through the message window
Instructions
1. Press the key to move the cursor in the message window.
2. Scroll through the messages: Move one element further with ↓,↑. Move four elements
further with / .
3. Exit the message window with or . The field “Log off” is automatically
activated and underlined in black.
5.3 Stop the blood pumps, switch off the Ikus
Popup menu “Drive off” with stop options
The popup menu “Drive off” contains the options
• Drive pause
• Pause left
• Pause right (only on biventricular)
• Drive off
↓,↑
changed to
Systolic pressure [mmHg] 60 to 350 2.5 25
Diastolic pressure [mmHg] 0 to -100 2.5 25
Rate [bpm] 30 to 150 1 10
Relative systolic duration [%] 20 to 70 1 10
↓,↑
changed to
24 1000002 Rev. 4.9.1

5.3.1 Drive pause: Stop the Ikus temporarily
Stop the blood pumps, switch off the Ikus
Instructions
1. Select “Drive pause”, then confirm with . Confirm the decision in the dialog window
with or . The Driving Unit Ikus stops. The “Operating mode” view appears.
2. Select Univentricular or biventricular, then confirm the desired operating mode with
. In biventricular mode, the view “Pump size and single-step mode” follows.
In univentricular mode, the connector seal test follows first, subsequently add the view
“Pump size and single-step mode”.
3. The cursor is positioned on OK. On confirming with , the system continues
running with the current settings. Important: As soon as the OK field is exited, all the
following steps of the start procedure are required (see page 33 ff.).
5.3.2 Pause left/Pause right: Stop individual blood pumps (and switch them off if necessary)
Instructions
1. Select “Pause left” or “Pause right”, then confirm with . Confirm the decision in
the dialog window with or . The selected blood pump stops. The “Pump size and
single-step mode” view appears.
2. To restart the pump, all the following steps of the start procedure are required (see
page 33 ff.).
Note
• The option “Pause right” is only available in biventricular mode. In univentricular mode,
this option is displayed, but it is deactivated. Only “Pause left” can be selected (even
in RVAD).
5.3.3 Drive off: Switch off the Ikus
Switch off the Ikus
Instructions
1. Check: Are the batteries fully charged (are all the yellow LEDs on the charge level
indicator illuminated?) If not: Proceed as described here up to and including step 4, then
switch off the laptop and leave the Ikus switched on until all the yellow LEDs are
illuminated. Then switch off the Ikus at the key switch.
2. In the monitoring program, select the option “Drive off”, then confirm with .
3. Confirm the decision in the dialog window with or . The system sets the
operation immediately and writes an operating log.
4. Wait until the log has been prepared. When the message “Switch off drive at the key
switch” appears, end the monitoring program with , then confirm the decision in
the dialog window with or .
5. In the start menu, select “End” (), then switch off the laptop.
6. When the batteries are completely charged, switch off the Ikus. In addition, set the key
switch to OFF [O].
Warning!
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN
when the Ikus is switched off!
Caution!
• Always follow the sequence described above. Always switch off the Ikus at the key switch.
• Only switch off the Ikus when the batteries are fully charged. (All the yellow LEDs on the
charge level indicator are illuminated.)
• Always keep unused driving tube connectors closed.
• When the Ikus is not used, start it up for 24 h each month to ensure that all the batteries
(especially the laptop batteries) are sufficiently charged, and perform the start test (see
Section 5.6 “Routine start test in the event of non-use” on page 28).
1000002 Rev. 4.9.1 25

Switching between mains power and battery mode
Instructions for use: Ikus
5.4 Switching between mains power and battery mode
Warning!
• The Ikus is designed for stationary operation and supply via the mains power network.
Only use battery mode when it is absolutely necessary (for example, when transporting
the patient).
• As long as the Ikus is in battery mode, a second person trained in the use of the manual
pump must be constantly present with the patient.
• Only disconnect the Ikus from the mains power when the charge level indicator shows
that the batteries are fully charged. (All the yellow LEDs are illuminated.) Important: To
prevent the batteries from wearing out quickly, every period of battery mode should be
followed by at least 6 h of mains power operation.
• If the LEDs on the charge level indicator are flashing or the message “Batteries
discharged - use power supply!” appears: Switch to mains power immediately!
• If the batteries are completely discharged (the red LED lights up), if you continue to run
in battery mode there is a risk of total failure of the Ikus and damage to the batteries.
Note
• As long as the Ikus is in battery mode, an acoustic signal sounds after 10 minutes. This
acoustic signal can be acknowledged.
• As soon as the batteries have reached a low charge level, the acoustic signal sounds once
every minute. The Ikus must be connected to the mains power supply immediately.
• Battery charge indicator: Depending on the Ikus model, 7 or 8 yellow LEDs show the
charge level of the batteries (see below). A red LED shows when the batteries are
completely discharged!
1 2
1) Battery charge indicator with 7 yellow LEDs, red LED on the left next to the yellow LEDs
2) Battery charge indicator with 8 yellow LEDs, red LED above the yellow LEDs
Recommendation
• Always have the mains power cable nearby when running in battery mode. This allows
you to restore mains power operation at short notice when required.
Switching to battery mode
Instructions
1. Set the power switch (mains power switch) to OFF/Aus [O]. The battery operation
indicator lights up.
2. Disconnect the Ikus from the mains power.
3. During operation in battery mode, pay attention to displays and messages. (See the
table corresponding to the number of yellow LEDs.)
26 1000002 Rev. 4.9.1

Behavior of the Ikus at different charge levels - Ikus with 7 LEDs
What? When? Meaning
The charge level indicator shows the
charge level of the batteries
Behavior of the Ikus at different charge levels - Ikus with 8 LEDs
Displays and messages in battery mode
Switch to mains power operation
always, except while
the batteries are
being charged
Switching from univentricular to biventricular mode
Charge level
The battery operation indicator lights up in battery mode Battery mode
Message: Battery mode, acoustic signal every 10 mins. OK; can be acknowledged by
pressing the button
Charge level indicator with 2 active
yellow LEDs
Remaining operating
time < 10 min
Battery status indicator flashing Remaining operating
time < 2 min
Message: “Batteries discharged - use
power supply!”
Remaining operating
time 0 min
What? When? Meaning
The charge level indicator shows the
charge level of the batteries
always, except while
the batteries are
being charged
Instructions
1. Connect the Ikus to the mains power supply.
2. Set the power switch (mains power switch) to ON/EIN. The mains power indicator lights
up. The battery operation indicator on the grip goes out. The batteries are charged.
5.5 Switching from univentricular to biventricular mode
Switch to mains power operation!
Switch to mains power
immediately!
The batteries are empty! Switch to
mains power without delay.
Otherwise, there is a risk of total
failure of the Ikus!
Charge level
The battery operation indicator lights up in battery mode Battery mode
Message: Battery mode, acoustic signal every 10 mins. OK; can be acknowledged by
pressing the button
Battery status indicator flashing Charge level < 50% Switch to mains power operation!
Message: Batteries discharged - use
power supply!
Charge level < 40% Switch to mains power
immediately!
Instructions
1. The new blood pump to be connected is de-aired and connected to the cannulas.
2. In the monitoring program, select the option “Drive pause”, then confirm with .
Confirm the decision in the dialog window with or . The active pump stops. You
arrive at the view “Operating mode”.
3. Open the blue marked driving tube connector.
4. When switching from RVAD to BVAD: Insert the plug of the already active pump from
the red marked connector into the blue marked connector. To do so, grab the plug by
the ribbed plug body and pull it out of the connector.
5. Insert the driving tube plug of the new de-aired pump into the free connector. The plug
1000002 Rev. 4.9.1 27

Routine start test in the event of non-use
Instructions for use: Ikus
snaps audibly into place. Check that the plug is firmly seated. To do so, pull the plug
above the ribbed plug body. Never pull on the tube!
6. Select the operating mode biventricular, then confirm with . All additional steps
are analogous to the start procedure (see page 33 ff.).
5.6 Routine start test in the event of non-use
Caution!
• When the Ikus is not used, start it up for 24 hours each month to ensure that all the
batteries (especially the laptop batteries) are sufficiently charged, and perform the
start test.
Instructions
1. Procedure as described in the section 6.1.1: “Connecting the vessel model”, p. 32 and
6.1.2: “Switch on the Ikus”, p. 32.
2. Wait 24 hours.
3. Procedure as described in 6.1.3: “Starting the monitoring program”, p. 32 and 6.1.4:
“Setting the test parameters”, p. 33 up to procedure step 2.
4. Observe and evaluate the curve representation.
5. Select the option “Drive off”, then confirm with .
6. Confirm the decision in the dialog window with or . The system sets the
operation immediately and writes an operating log.
7. Wait until the log has been prepared (message: “Switch off the drive at the key switch”).
8. End the monitoring program and switch off the laptop.
9. Provided that all of the yellow battery LEDs are illuminated, switch off the Ikus.
In addition, set the key switch to OFF [O].
10. Disconnect both pressure vessels from the Ikus.
11. Seal the driving tube connection sockets with seal plugs.
If the system detects an error in the start test
Instructions
1. End the monitoring program according to the instructions in the dialog.
2. Switch off the Ikus at the key switch. Important: The power switch (mains power switch)
remains on ON/EIN!
3. Important: Wait 10 minutes.
4. Restart the start procedure (see above).
If the system again detects an error in the start test and/or not all of the battery LEDs are
illuminated after 24 hours:
Notify hotline! +49(0)30 8187 2772
28 1000002 Rev. 4.9.1

5.7 Moving the Ikus
Grip: Sliding the Ikus
Grip and lifting bars
Caution!
• Sliding the Ikus: Only slide the Ikus using the grip provided for that purpose. Avoid jerky
motions. When moving over small obstructions, exercise caution. If necessary, pull the
Ikus backward (with the grip first) over the obstruction.
• Sliding the Ikus over a sloping surface: Ensure that the person pushing it is strong
enough to push the Ikus in a controlled manner.
• Lifting the Ikus: Only lift the Ikus by the lifting bars provided for that purpose on the
lower edge of both sides. Never lift the Ikus by its grip. Always lift the Ikus between two
people, preferably between four people.
5.8 Packaging and transport
Warning!
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN
during non-use and transport.
Caution!
• Always keep unused driving tube connectors closed.
• Lifting the Ikus: Only lift the Ikus by the lifting bars provided for that purpose on the
lower edge of both sides. Never lift the Ikus by its grip.
• Only use the supplied original transport crate when sending the Ikus back to Berlin
Heart GmbH.
• Ensure that the Ikus is placed firmly and securely inside the transport crate and that the
transport crate is correctly closed.
• The crate may only be transported as shown. Do not tilt or overturn the Ikus when it is
packed inside the transport crate.
• Always observe a resting period of six hours after each transportation before switching
on the Ikus!
The original transport crate consists of:
• 2 base plates
• 2 longitudinal side parts
• 2 lateral side parts
• 1 cover
Lifting bars: Lifting the Ikus
Moving the Ikus
1000002 Rev. 4.9.1 29

Packaging and transport
Instructions for use: Ikus
Packing the Ikus
Instructions
1. Slide the closed laptop holder to the end position in the direction of the display and
operating panel. If possible Fix the laptop with (adhesive) tape.
2. Place the smaller base plate in the lower part of the crate.
3. Lifting the Ikus with the base plate: To do so, grab the lifting bars of the Ikus on the lower
edge of the longitudinal sides and lift the Ikus carefully onto the base plate. Avoid tilting
it. The wheels of the Ikus are parallel to the side walls and face outward.
4. Check that the manual pump is fixed in the clamp.
5. Place the longitudinal and lateral side parts on the base plate and tighten the bolts.
6. Close the transport crate with the lid and secure it with bolts.
7. Secure all the bolts with cotter pins or cable tie straps.
1
1) Complete Ikus transport crate, 2) Details of bolts secured with cotter pins
Note
• During transport, the key remains inserted into the key switch (position OFF [O]).
• Ikus dimensions (B x H x T): 46 x 95 x 73 cm (with the laptop closed)
• Ikus weight: 93 kg
30 1000002 Rev. 4.9.1
2

6 Start up the Ikus and set the parameters
Preparations outside of the operating room
Warning!
• Before every commissioning of the Ikus, you must check that a replacement Ikus or
Berlin Heart GmbH service is available within 24 hours.
• If you are using a laptop of the type Panasonic CF29, always observe the additional
information (Section 13.9 on p. 99)!
Caution!
• Always observe a resting period of six hours after each transportation before switching
on the Ikus.
• Before every commissioning of the Ikus, check that the environmental conditions are
respected (see Section 13.2 “Technical specifications” on page 89).
• Always keep unused driving tube connectors closed.
Note
• This chapter describes the technical aspects of comissioning as well as perioperative
and postoperative drive management. During commissioning, always pay attention to
the chapter 8: “Implantation – Surgical procedure”, p. 45.
• The described procedure for drive management consists of recommendations. They do
not replace conscientious observation and evaluation by competent personnel.
6.1 Preparations outside of the operating room
•
Warning!
Switch on the Ikus two hours before its planned use, so as to charge the batteries
(in particular the laptop battery) sufficiently and to detect a possible device error by
means of the start test. During this period, always connect the vessel models to the Ikus
(see below).
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN –
even in battery mode and when the Ikus is switched off! Otherwise, there is a risk of
failure of the driving unit due to completely discharged batteries. The only exception is
battery mode: Before switching to battery mode, move the power switch (mains power
switch) to the OFF/Aus [O] position. Immediately after restoring the power connection,
move the power switch back to the ON/Ein [I] position.
• 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.
1 2 3
8
Connection panel
7 6 5
1000002 Rev. 4.9.1 31
4
4
1. Driving tube connectors
2. Battery fuse
3. Mains power indicator
4. Power switch (mains power switch)
5. Mains power connector
6. Main switch (key switch; O/I)
7. Potential equalization connection
8. External alarm connector (nurse call)

Preparations outside of the operating room
Start up the Ikus and set the parameters
6.1.1 Connecting the vessel model
Pressure vessel
Note
• The vessel model consists of two separate pressure vessels each equipped with a
driving tube.
• The vessel model simulates a real operating situation during the warming-up period.
If the test parameters (see page 33) have been set correctly, it prevents the Ikus from
generating spurious error messages.
Instructions
1. Remove the seal plugs from the driving tube connection socket.
2. Connect the plug of the two pressure vessels to the driving tube connection sockets.
Caution!
• Always connect both pressure vessels!
6.1.2 Switch on the Ikus
Instructions
1. Connect the Ikus to the mains power supply. Secure the mains power cable with a plug
clip. Ensure that the power switch (mains power switch) is set to ON/EIN.
2. Set the key switch to ON [I]. The charge level indicator lights up and the elapsed
operating hours are displayed. The mains power indicator lights up.
3. Switch on the laptop after the boot process. The language selection menu appears.
4. Select the language by entering the corresponding number. A confirmation with
is not required.
5. The start menu appears.
Caution!
• When switching on the Ikus, always connect it to the power supply. This is the only way
to ensure that the start test (see below) is performed completely and possible
malfunctions can be detected.
• Always switch on the driving unit first and then the laptop.
6.1.3 Starting the monitoring program
Instructions
1. Select the option “Start program”() from the start menu.
2. Enter the user number and password, then confirm with . The system runs
through the start test.
3. Wait for the test phase (a few minutes). Do not acknowledge the acoustic signal.
Exception: If an error message is displayed. Messages in the message window inform you
about the current status. If the system is error-free, the “Operating mode” view appears.
32 1000002 Rev. 4.9.1

6.1.4 Setting the test parameters
Systole [mmHg]
left/right
Intraoperative drive management
Note
• In the delivery state, the Ikus has standard parameters by default, which the Ikus works
with after each complete start-up process (see page 28 and page 80. However, during
the warming-up period with the vessel model, it is necessary to set the test parameters
to prevent the Ikus from generating a spurious error message.
Diastole [mmHg]
left/ right
Test parameters
Instructions
1. Also with planned univentricular mode: Navigate the cursor to biventricular, confirm with
. You arrive at the view “Pump size and single-step mode”.
2. Place the cursor with ↑ in the parameter table and navigate with ← / → to the desired field
in the parameter table. Adjust the value with ↓,↑ or / , then confirm with
.
3. Check whether the batteries are sufficiently charged.
4. Disconnect the plug from the power supply and bring the Ikus immediately into the
operating room. Acknowledge the message (battery mode) by pressing the button.
5. In the operating room: Reconnect the Ikus to the power supply.
If the system detects an error:
Instructions
1. End the monitoring program according to the instructions in the dialog window.
2. Switch off the Ikus at the key switch. Important: The power switch (mains power switch)
remains on ON/EIN!
3. Wait 10 minutes.
4. Restart the start-up procedure (see page 32).
Note
• An overview of the possible messages during the start test can be found in Section 11.27
on p. 73.
• In the parameter table, the display FAILURE indicates an error in the start test.
• Possible error causes include operating errors on the last shutdown or in the startup
procedure.
If the system detects an error again:
Do not use the Ikus.
Rate [bpm]
Notify hotline! +49(0)30 8187 2772
6.2 Intraoperative drive management
6.2.1 Disconnect the vessel model from the Ikus
Rel. systolic duration [%]
left/right
Instructions
1. Disconnect both pressure vessels from the Ikus.
2. Seal the driving tube connection sockets with seal plugs.
Operating mode/
mode
200 0 70 40 biventricular,
synchronous mode
1000002 Rev. 4.9.1 33

Intraoperative drive management
Start up the Ikus and set the parameters
6.2.2 Select the operating mode (“Operating mode” view)
“Operating mode” view
Instructions
1. In the operating room: Immediately restore the mains power supply.
2. Move the cursor to univentricular or biventricular, then confirm the desired operating
mode with .
3. During biventricular mode: You arrive at the view “Pump size and single-step mode”
(Section 6.2.3 on p. 34).
During univentricular mode, the connector seal test follows: The Ikus checks that the blue
marked driving tube connector is closed.
Univentricular mode: Connector seal test
Instructions
1. The message “Please close the right outlet” appears. Check the blue marked driving tube
connector. If the connector is open: Close it with the seal plug.
2. Move the cursor to OK, then confirm the message with . The Ikus checks that
the connector is actually closed. If this is the case, you arrive at the view “Pump size and
single-step mode”. Otherwise, the Ikus repeats the connector seal test.
Note
• The Ikus repeats the connector seal test up to three times. Then the system switches
itself off. Then contact Berlin Heart GmbH service.
6.2.3 Selecting the pump size
Instructions
1. In the popup menu, select the desired pump size with ↓,↑ .
2. During biventricular mode: Move the cursor with ← / → to the field “right pump”, then
select the desired pump size with ↓,↑ .
Popup menu for pump size selection
Note
• The selected size and rate of the right blood pump cannot be larger than the left pump.
The list of the pump sizes for the right pump is restricted accordingly.
34 1000002 Rev. 4.9.1

6.2.4 Setting the startup parameters
Systole [mmHg]
left/right
“Pump size and single-step mode” view with recommended startup parameters
Warning!
• Especially after previous ECMO it is necessary to change the settings of the start
parameters before starting the system.
Intraoperative drive management
Instructions
1. Place the cursor with ↑ in the parameter table and navigate with ← / → to the desired field
in the parameter table. Adjust the value with ↓,↑ or / , then confirm with
.
2. Setting the startup parameters:
Startup parameters
Diastole [mmHg]
left/right
6.2.5 Connect the blood pump(s) to the Ikus
Rate [bpm]
100/ 80 -5/-5 30 40/40
Note
• Condition of the blood pump(s) on connecting: Filled with sterile saline solution, with
the de-airing needle fitted. For easier handling after connecting the pump(s), the driving
tubes are not connected until after the inflow and outflow cannulae are connected to the
pump (see page 50).
Instructions
1. Open the red marked connector (univentricular) or both connectors (biventricular).
To do so, pull the seal plug out of the connector(s).
2. Connect the driving tube to the Ikus. To do so, insert the plug of the tube into the
connector. The plug snaps audibly into place. Check that each plug is firmly seated.
To do so, pull the plug above the ribbed plug body. Never pull on the tube!
3. During biventricular mode: Observe the colored markings.
4. During biventricular mode: Repeat with the second pump.
Operating mode Connector on the Ikus
biventricular LVAD: red marked connector
RVAD: blue marked connector
univentricular LVAD or RVAD: red marked connector
Allocation: Operating mode, blood pump, connector
Rel. systolic duration [%]
left/right
1000002 Rev. 4.9.1 35

Intraoperative drive management
Start up the Ikus and set the parameters
Caution!
• Do not bend the driving tubes!
6.2.6 De-air the pump(s) in single-step mode
Note
• With each de-airing step, one half pump cycle (= one systole or one diastole) is covered;
first step: diastole. Normally, several de-airing steps are required for each pump.
• The pumps work in single-step mode with the pressures shown in the parameter table.
• Only when at least one de-airing step per pump has been performed is it possible to
switch to normal view.
Instructions
1. Bring the patient into the Trendelenburg position.
2. Move the cursor into the field “Step left”.
3. Lift up the pump. The de-airing nipple of the blood pump is the highest point.
4. Confirm with to trigger a single-step. If necessary, de-air the pump via the
de-airing needle (see page 43). In consultation with the surgeon: With , trigger
additional individual steps until the pump is completely de-aired. If the pump does not fill
correctly: If necessary, increase the suction pressure slightly.
5. During biventricular mode: Move the cursor into the field “Step right”. Repeat the deairing
with the second pump.
Single-step mode; transfer to constant mode is not yet possible (OK is deactivated)
6.2.7 Start the pump (switch to normal view)
Warning!
• Only start the blood pump(s) after they are completely de-aired!
• Only remove the de-airing needle if the blood pump is running and the parameters have
been adjusted (see below and page 51).
Instructions
1. Move the cursor to OK, then confirm with . The system now starts with the
parameter values visible in the parameter table.
6.2.8 Check and adjust the parameters when the pump is started
Warning!
• Adjust all parameters only gradually to prevent the aspiration of air into the blood pump
through the cannula anastomosis. However, should air get inside the system, pull the
driving tubes off the driving unit and de-air the system via the de-airing needle.
• Constantly monitor all of the settings.
Instructions
1. Observe the left blood pump. Does the pump eject completely? If not: If necessary,
increase the driving pressure on the left.
2. Observe the right blood pump. Does the pump eject completely? If not: If necessary,
increase the driving pressure on the right.
36 1000002 Rev. 4.9.1

Intraoperative drive management
Note
• If the pump filling is very poor in this phase, volume can firstly be supplied from the
HLM and then the membrane movement and the ejecting can be optimized. To do so,
proceed according to the table:
Observe: Corrective action
Right pump:
Is the pump filling well?
(see below)
Left pump:
Is the pump ejecting well?
Compare the left and right pumps
Is the left pump filling clearly
worse than the right?
Pump filling criteria
When filling the right pump, observe:
The target is an extensive bypass of the right ventricle, not a complete bypass. Evidence
of a complete bypass of the right ventricle includes:
• Pump filling is strongly dependent on the respiratory cycle
• Empty / limp ventricle
• Abrupt stopping of the membrane during filling
Important: If the above three points all apply, corresponding corrective action must
be taken:
• Reduce the suction pressure
• Substitute volume
Adjust the parameters
Instructions
1. Move the cursor with ← / → to the desired field in the parameter table. The active field
is colored underneath.
2. Set the parameter value with ↓,↑ or / , then confirm with .
Parameter: possible ranges
If not: Check the filling pressure (central venous pressure; CVP).
CVP low: Substitute volume
CVP high: Increase the suction pressure, while avoiding the aspiration of air.
If no improvement occurs: Check the cannula position via echo!
If not: Check the mean arterial pressure
(Guideline value: 70 mmHg)
If yes: Increase the suction pressure on the left, while avoiding the aspiration
of air.
If no improvement occurs: Check the cannula position via echo!
Parameter possible range ↓,↑ changed to
Systolic pressure
[mmHg]; driving pressure
Diastolic pressure
[mmHg]; suction pressure
60 to 350 2.5 25
0 to -100 2.5 25
Rate [bpm] 30 to 150 1 10
Relative systolic duration
[%]
20 to 70 1 10
/
changed to
Biventricular: Adjust the operating mode
If you want the pumps to work in any other mode than synchronous mode, you can set the
desired operating mode.
• asychronous mode is recommended for patients with a small thorax volume in relation
to the pump volume. Through the asynchronous mode, the intrathoracic blood volume
1000002 Rev. 4.9.1 37

Intraoperative drive management
Start up the Ikus and set the parameters
remains identical.
• separate pulse is sometimes helpful in patients with intracardial shunts.
Instructions
1. Move the cursor with ← / → to the field with the current operating mode display.
A popup menu appears showing the possible operating modes.
2. Select the desired operating mode with ↓,↑, then confirm with . The system
works in the set operating mode.
Target values
Systole [mmHg]
left/right
The most important criterion when selecting the drive parameters is good filling and emptying
of the pump; the settings must be oriented toward achieving this goal.
Note
• The systolic driving pressure must be higher than the systolic pressure of the patient.
Important: When the systolic duration is shortened or with very small cannulas, a higher
value may need to be selected than recommended here.
• The driving pressures reached are dependent on the diameter of the cannulas used.
• The following values are only guideline values; they are not authoritative in individual
cases!
Diastole [mmHg]
left/right
Recommended target values for normal operation
Recommendation
• Now remove the de-airing needle (see page 51).
Warning!
• On removing the de-airing needle, never pull on the de-airing tube, but rather on the deairing
needle itself.
6.2.9 Switching from HLM to VAD
Rate [bpm]
220/150 -40/-40 80 40/40
rel. systolic duration [%]
left/right
The goal is to reduce the HLM flow and thus shift the volume from the HLM to the
patient (to the VAD).
Instructions
1. If firstly the right blood pump and then the left blood pump too begin to fill, reduce the
HLM flow and increase the EXCOR rate firstly from 30 bpm stepwise, until the desired
flow is reached. Important: In doing so, ensure sufficient filling, and if necessary regulate
the driving pressure!
2. If necessary, regulate the suction pressure.
Note
• If stage cannulas or a connecting set are used, the pumps do not eject fully at a rate
of > 100 bpm. With these cannulas, rates of > 100 bpm should be avoided.
Recommendation
• To secure the driving tubes to the cannulas, as soon as the system is running stably
(see page 51).
38 1000002 Rev. 4.9.1

6.2.10 Possible complications
Intraoperative drive management
Deteriorated filling after stable inflow conditions
If at first a good filling is achieved with sufficient drainage and target rate (generally
80 bpm) (filling pressure LA/CVP < 10mmHg and/or diastolic pulmonary-arterial
pressure < 15mmHg), which deteriorates afterwards, an increase in the suction pressure
is not useful.
Filling that deteriorates after stable inflow conditions suggests a lack of volume or an
inflow obstruction, the causes of which must be identified and eliminated.
Note
• Manipulations during the implantation may massively influence the inflow temporarily
– before adjusting the values, wait for the situation to stabilize.
Instructions
1. Substitute volume (remaining volume from HLM, etc.) or correct the cannula position.
Deteriorated filling with thorax closure
In atrial cannulation with thorax closure, a slight deterioration in drainage can
sometimes be observed. This can be caused by a compression of the atria or a slight
shifting of the cannulas.
Instructions
1. Substitute volume. Important: Observe the effect of the pump filling!
2. Increase the vacuum. However: Extremely high vacuums in pumps with tilting-disk
valves only appear to lead to better filling (due to the increased leakage flow through the
closed outflow valve in the diastole).
Clear deterioration or generally poor inflow conditions on the right
Instructions
1. Rule out the possibility of an upper inflow congestion.
2. If a vacuum below -50mmHg is necessary, also extend the relative diastole duration.
To do so, reduce the relative systolic duration. Important: Increase the driving pressure
accordingly!
Incomplete ejecting on the right / left
Instructions
1. Observe the arterial blood pressure; at the same time, observe the ejecting movement
of the pump membrane.
2. Adjust the driving pressure accordingly if complete emptying of the pump no longer
occurs. Important: Do not react to extreme – but temporary – arterial pressure increases
(due to manipulation, catecholamine, etc.).
1000002 Rev. 4.9.1 39

Postoperative drive management
Start up the Ikus and set the parameters
6.3 Postoperative drive management
Precondition: The patient comes from the operating room with stable circulatory status.
Note
• Post-operative patient care after EXCOR implantation is similar to the care required after
any open heart cardiac procedure.
• Positioning of the patient is possible.
6.3.1 After transfer to the ward
If, directly after the operation, good filling and secure ejecting of the pump(s) is
observed, then adjustment of the driving and negative pressure is generally not required.
• Good filling, i.e. sufficient suction pressure
• Secure ejecting (at normal arterial blood pressures), i.e. sufficient driving pressure
Warning!
• Check at least three times a day by visual inspection over several pump cycles that the
pump(s) is/are filling and emptying completely. If a pump does not fill and/or empty
completely, then corresponding corrective action must be taken.
Note
• On the regular inspection of blood pump(s) and cannulas, see page 58.
6.3.2 After further progress
Note
• Target values and criteria for adjustment of the parameter values: see page 38.
• A driving pressure adjustment at the left is only necessary
• if the arterial blood pressure increases (e.g. after ending sedation, awakening of
the patient).
• during mobilization (upright body posture, sitting, standing – to compensate for
the additional hydrostatic pressure).
40 1000002 Rev. 4.9.1

Preparing the components and materials
7 Implantation: Preparation in the operating room
7.1 Preparing the components and materials
General
• 500 ml sterile saline solution
• 2 conical metal beakers
• Disposable syringe 50 ml
• Ligature (for de-airing nipples)
• Shears
• Towel clamp
• Instruments and equipment as usual for open-heart surgery
EXCOR components and accessories
• Blood pump(s), each with a pump seal
• One driving tube per blood pump
• univentricular: Red driving tube
• biventricular: One red driving tube and one blue driving tube
• Inflow cannula(s) (atrial or apex cannula)
• Outflow cannula(s)
• Accessory set T00L-001 / T00L-002 (for blood pumps with tilting-disk valves / PU valves)
• Pressure gauge set with pressure valve (T00L-001)/ membrane set (T00L-002)
• De-airing set (2 x trocar, 2 x de-airing tube)
• De-airing hammer
• Tube attachment set (cable tie strap, cable tie pliers)
Note
• Selection of the blood pump(s): See“Overview: Ratio of body weight - pump size” on
page 87.
Recommendation
• In addition, provide a sterile table to prepare the components.
7.2 Unpacking the sterile components
Warning!
• Use only sterile components with intact sterile packaging (undamaged sterile package,
unexpired use-by date)!
• Only use blood pumps with intact aluminum-coated outer packaging.
Instructions
1. Pump: Nonsterile person opens aluminum-coated outer packaging and removes
double-sterile-packaged pump.
2. Nonsterile person opens outer sterile package.
3. Sterile person removes and opens inner sterile package and prepares components.
7.3 Atrial cannulas with mandrin: Prepare the cannula
Note
• Atrial cannulas with mandrins are recommended for the cannulation of the left atrium.
For the cannulation of the right atrium, a cannula with a mandrin is not required.
1000002 Rev. 4.9.1 41

Pump with PU valve
Implantation: Preparation in the operating room
Instructions
1. Moisten the entire inner surface of the cannula. To do so, bend the cannula slightly, hold
it horizontally, fill it with sterile saline solution and move it slightly backward and forward.
2. Moisten the mandrin with sterile saline solution.
3. Introduce the mandrin straight into the cannula from the outflow side. To do so,
superextend the cannula head slightly. Pull the mandrin forward and backward slightly.
Caution: Avoid rotating movements to prevent damage to the inner surface of the
cannula! Proceed with extreme caution!
4. Situate the mandrin. The mandrin is correctly situated if the cannula head is locked.
Tighten the lock nut of the mandrin to fix the mandrin in place.
7.4 Pump with PU valve
b
a
De-airing nipple and driving tube connector
Move the membrane into the end-of-diastole position
Instructions
1. Have the adapter tube and disposable syringe (membrane set) and the pump at hand.
2. Fit the adapter tube to the disposable syringe.
3. Fit the free end of the adapter tube to the driving tube connector of the pump.
4. Suck the air completely out of the air chamber of the pump. The membrane is located in
the end-of-diastole position.
5. Lock the adapter tube with the tube clamp to secure the membrane position.
7.5 Pump with tilting-disk valve
Check the tightness and bring the membrane into the end-of-diastole position
a
b
c
d
Pressure gauge set
a De-airing nipple (blood chamber)
b Driving tube connector (air chamber)
42 1000002 Rev. 4.9.1
e
f
g
a Seal
b Short tube section 12 mm
c Adapter
d Short tube section 9 mm
e Air filter
f Pressure gauge
g Long tube section

Instructions
1. Keep the pressure gauge set and the pump at hand.
2. Seal the outflow side of the pump with the seal.
3. Connect the pressure gauge set together (see image). To do so, moisten all the
silicone parts.
4. Fit the free end of the pressure gauge set to the inflow side of the pump.
5. Increase the pressure with the pressure gauge. The membrane is located in the end-ofdiastole
position.
6. Build up more pressure: 300 mmHg. The pressure must remain constant over 30 s.
Continue maintaining the pressure.
7. If the pressure remain constant over 30 s: Check that the connector nuts are firmly seated.
To do so, hold the titanium connector tightly, fix the supplied key to the connector nut
and check carefully that the nut can be tightened in the direction of the arrow (see table).
8. Leave the pressure gauge set connected to secure the membrane position.
Caution!
• Never twist the connectors because this would damage the seals.
Status of the pump and nuts What should be done?
The connector nut is firmly seated, and the pump
does not leak air.
The connector nut can be turned, and the pump
does not leak air.
The connector nut can be turned,
and the pump leaks air.
The connector nut is firmly seated, but the pump
leaks air.
7.6 De-air the pump
Preparation:
• Pump with pump seal
• For each pump, there is one de-airing set (trocar and de-airing tube)
• Each pump has one disposable syringe (50 ml)
Pump with inserted trocar (de-airing needle with inserted obturator)
Situate the de-airing needle
c
b
d
e
Use the pump. Never overtighten the nut.
Carefully turn the nut in the direction of the arrows
until tight.
Carefully turn the nut in the direction of the arrows until
tight, then check again. The pump is still leaking air: Do
not use the pump. Return the pump to the manufacturer.
Do not use the pump. Return the pump to the
manufacturer.
a
a Trocar (de-airing needle with inserted obturator)
b De-airing nipple
c Blood chamber
d Membrane in end diastole position
e Air chamber
Caution!
• The membrane must now be located in the end-of-diastole position. The membrane set
or pressure gauge set is now connected.
De-air the pump
1000002 Rev. 4.9.1 43

De-air the pump
Implantation: Preparation in the operating room
Instructions
1. Have the trocar (de-airing needle with obturator) at hand. Remove the protective silicone
cap.
2. Insert the trocar as shown above through the middle of the de-airing nipple of the pump
up to the stop. To do so, turn the trocar slightly (max. 10°) back and forth.
3. Remove the obturator.
4. Pull back the de-airing needle approx. 2 mm. Important: The tip of the cannula is still
visible in the blood chamber.
5. Fix the de-airing needle to the de-airing nipple using the ligature.
6. Pump with PU valves: Pull the adapter tube off the pump.
7. Pump with tilting-disk valves: Pull the tube of the pressure gauge set off the pump, pull
the pump seal off the outflow side and lay both of them out.
Rinse and fill the blood pump
Instructions
1. Fill the pump once or twice with sterile saline solution. To do so, pour sterile saline
solution through the inflow connector into the pump. Empty the pump.
2. Insert the free end of the de-airing tube onto the de-airing needle up to the stop.
3. Fill the syringe with sterile saline solution.
4. Connect the syringe to the stop cock of the de-airing tube.
5. Slowly fill the pump with sterile saline solution. Move possible air bubbles to the outflow
stub by swinging the pump.
6. Lock the stop cock of the de-airing tube.
7. Tap lightly with the de-airing hammer against the pump housing to dislodge air bubbles.
De-air the pump fully via the de-airing needle and the outflow stub.
8. Close both titanium connectors with the pump seal.
9. Lay out the prepared pump. The connectors point upward.
Recommendation
• Before starting the operation, mark the later incision wound sites of the cannulas.
The goal is a stable and tension-free spatial end position of the cannulas. In the case
of biventricular assistance/ support, ensure that two of the four cannulas cross over.
If possible, this should occur outside of the thorax.
44 1000002 Rev. 4.9.1

8 Implantation – Surgical procedure
This chapter describes the product-specific measures during the implantation of an
EXCOR blood pump. The setting of the Ikus parameters during and after implantation are
described separately in section “Start up the Ikus and set the parameters” on page 31. If
the Driving Unit Ikus is brought into the operating room, it should be prepared as
described in section 6.1: “Preparations outside of the operating room”, p. 31.
If not described otherwise, all actions must be performed as in large cardiothoracic
surgery interventions. The implantation is accomplished with the use of the HLM,
utilizing standard techniques of cardiothoracic surgery. The implantation may be
performed under induced ventricular fibrillation or on the beating heart. Hypothermia is
not normally required.
Warning!
• Only start the blood pumps after they are completely de-aired!
• Do not touch the pump with pointed or sharp-edged objects (surgical instruments)!
• If a cannula is bent with a flexible metal reinforcement to adjust it to the anatomical
conditions: Determine by visual inspection that the blood flow in the cannula is not
restricted.
Recommendation
• For BVAD, perform the anastomosis of the cannulas in the following sequence:
• apical cannulation:
1. apex
2. right atrium
3. pulmonary artery
4. aorta
• atrial cannulation:
1. left atrium
2. right atrium
3. pulmonary artery
4. aorta
8.1 Access
Instructions
1. Median sternotomy Ensure complete blood dryness.
2. Apply cannulation for HLM (bicaval cannulation).
3. Start the cardiopulmonary bypass.
4. Place a vent in the LA if necessary.
8.2 Apex cannula(s)
8.2.1 Anastomosing the apex cannula
Warning!
• During the anastomosis of the apex cannula, ensure the orientation of the cannula head:
The long side of the head should lie parallel to the sidewall of the heart. In this way,
aspiration of the sidewall can be prevented. After introducing the cannula head, its
position can be checked by means of the flow direction arrow on the cannula body
(except for apex cannulas C10A-030, C14A-040 and C18A-020): The arrow is aligned with
the long side of the cannula head.
Access
1000002 Rev. 4.9.1 45

Apex cannula(s)
Implantation – Surgical procedure
Head of an apex cannula
Instructions
1. Start fibrillation if necessary.
2. Perform the apical excision. The excision of a cone is recommended. Select the diameter
of the excision so that it is slightly smaller than the cannula diameter.
3. Inspect the cutting edge for cut trabeculae.
On cannulas without a separate suture ring
Instructions
a
a Long side of the cannula head
Circularly applied sutures at the apical incision
On a cannula with an additional suture ring (apex cannula C41A-050, inner diameter 16 mm)
Instructions
1. Induce ventricular fibrillation if necessary.
2. Apply 12 - 14 felt-underlaid, double-reinforced sutures (monofilament threads,
e.g. 3-0 SH-1) circularly around the apical incision. Do not fasten.
3. Pierce the suture ring with the apex sutures.
4. Lead the suture ring under the sutures and fasten the sutures. Ensure that the ring lies
flat and without folds.
5. Introduce the inflow cannula into the apex of the ventricle.
6. Stitch the apex ring with the suture ring of the inflow cannula: running suture.
8.2.2 Create the transcutaneous passage for the apex cannula
1. Apply 12 - 14 felt-underlaid, double-reinforced sutures
(monofilament threads, e.g. 3-0 SH-1) circularly around
the apical incision. Do not fasten.
2. Pierce the suture ring of the cannula with the apex
sutures.
3. Lead the cannula under the sutures and fasten the
sutures.
4. De-air the cannula and close it underneath the
anastomosis with a tube clamp or vent over the cannula.
Warning!
• Ensure that the cannulas assume a stable and tension-free spatial end position!
• Never touch silicon cannulas with pointed or sharp-edged objects (surgical instruments).
• When using the dressing forceps, always ensure that the inside of the cannula is not
damaged. Place a compress over the cannula opening and then access it with the forceps.
• The incision must be smaller than the cannula diameter (for good healing), but
sufficiently large to prevent necrosis.
• Ensure a sufficient expanse of unbroken skin between the incision wounds.
46 1000002 Rev. 4.9.1

Instructions
1. Prepare the incision wound. Ensure an appropriate incision size.
2. Open the pericardium wide laterally. Prepare the cannula tunnel bluntly. Important: Do
not tunnel transperitoneally.
3. Pull the apex cannula through the tunnel with the aid of dressing forceps. Important: Do
not twist the cannula when pulling it. At the end, the cardiac apex should assume a
natural, torsion-free position.
4. Defibrillate if necessary.
8.3 Atrial cannula(s)
Recommendation
• For cannulas with flexible metal reinforcement, create the transcutaneous passage first
and then create the anastomosis.
• If a mandrin is used, the anastomosis must be created first before removing the mandrin
and then creating the transcutaneous passage.
• For all other cannulas, the sequence is arbitrary.
8.3.1 Creating a transcutaneous passage for atrial cannula(s)
Instructions
1. Prepare the incision wound. Ensure an appropriate incision size.
2. Prepare the cannula tunnel bluntly. Important: Do not tunnel transperitoneally.
3. Pull the atrial cannula through the tunnel with the aid of dressing forceps. Important: Do
not twist the cannula when pulling it.
Warning!
• Ensure that the cannulas assume a stable and tension-free spatial end position!
• Never touch silicon cannulas with pointed or sharp-edged objects (surgical instruments).
• When using the dressing forceps, always ensure that the inside of the cannula is not
damaged. Place a compress over the cannula opening and then access it with the forceps.
• The incision must be smaller than the cannula diameter (for good healing), but
sufficiently large to prevent necrosis.
• Ensure a sufficient expanse of unbroken skin between the incision wounds.
8.3.2 Anastomize the inflow cannula(s) with an atrium
1
Right atrium
a) Closed technology
Anastomosing the atrial cannula(e)
Instructions
2 1. With a monofilament thread, describe a running
suture underlaid at four points with felt.
2. On four sides of the octagon thus formed, apply
Teflon-reinforced individual U-sutures.
Suture technique for the right atrium
Atrial cannula(s)
1000002 Rev. 4.9.1 47

Outflow cannula(s)
Implantation – Surgical procedure
Cannulation of the right atrium
b) Open technique with bicaval cannulation
In bicaval cannulation, the right atrial cannula can be introduced in an open technique.
Left atrium
The anastomosis on the left atrium is performed in a similar way to the right atrium. For
the use of an atrial cannula with a mandrin: Remove the mandrin before de-airing the
cannula. In doing so, only pull the mandrin longitudinally, never twist it!
Recommendation
• To create the anastomosis at the junction of the upper right pulmonary vein in the left
atrium. The atrium wall is recommended as the implantation site. The pulmonary vein
itself should be left intact.
8.4 Outflow cannula(s)
3. Make a sufficiently long incision in the suture
circle and extend it.
4. Lead the cannula under the sutures,
simultaneously throttle the venous backflow
slightly to the HLM and inflate the lung to
prevent underpressure in the LA.
5. De-air the cannula and close it underneath the
anastomosis with a tube clamp.
Recommendation
• For cannulas with flexible metal reinforcement, create the transcutaneous passage first
and then create the anastomosis.
• If a mandrin is used, the anastomosis must be created first before removing the mandrin
and then creating the transcutaneous passage.
• For all other cannulas, the sequence is arbitrary.
8.4.1 Creating transcutaneous passages for outflow cannula(s)
Instructions
1. Prepare the incision wound. Ensure an appropriate incision size.
2. Prepare the cannula tunnel bluntly. Important: Do not tunnel transperitoneally.
3. Pull the outflow cannula(s) through the tunnel with the aid of dressing forceps.
Important: Do not twist the cannula(s) when pulling.
Warning!
• Ensure that the cannulas assume a stable and tension-free spatial end position!
• Never touch silicon cannulas with pointed or sharp-edged objects (surgical instruments).
• When using the dressing forceps, always ensure that the inside of the cannula is not
damaged. Place a compress over the cannula opening and then access it with the forceps.
• The incision must be smaller than the cannula diameter (for good healing), but
sufficiently large to prevent necrosis.
• Ensure a sufficient expanse of unbroken skin between the incision wounds.
48 1000002 Rev. 4.9.1

8.4.2 Anastomosing the outflow cannula(s)
Aorta
Instructions
Anastomosis of the aortal cannula
Pulmonary artery
Instructions
Cannulation of the pulmonary artery
8.5 If necessary: Shorten the cannulas
If necessary: Shorten the cannulas
1. Clamp off the aorta ascendens tangentially and open it
longitudinally in a stretch appropriate to the cannula
diameter. Stagger the incision up to 45° dextrolaterally.
2. Anastomize the cannula with ten Teflon-backed,
double-reinforced individual U-sutures (monofilament
threads, e.g. 4-0 EB) (alternatively with a continuous
suture).
3. De-air the cannula and close it underneath the
anastomosis with a tube clamp.
1. Open the pulmonary artery longitudinally in a stretch
appropriate to the cannula diameter.
2. Anastomize the cannula with ten Teflon-backed,
double-reinforced individual U-sutures
(monofilament threads, e.g. 4-0 EB) (in clear
conditions, alternatively with a circulating suture).
3. De-air the cannula and close it underneath the
anastomosis with a tube clamp.
Instructions
1. Cut the cannula to the desired length. Cut perpendicular to the cannula axis and ensure
a straight cut.
2. Ensure that the length of both cannulas corresponds: The cannulas must be connected
to the pump without tension.
Recommendation
• To shorten the cannulas, use the cutting tool available from Berlin Heart GmbH
(see page 88).
1000002 Rev. 4.9.1 49

Connect the pumps to the cannulas
Implantation – Surgical procedure
8.6 Connect the pumps to the cannulas
Warning!
• When connecting the blood pump(s), pay attention to the arrows on the inflow and
outflow stubs. These show the blood flow direction.
Note
• Depending on the site of the anastomosis, the air or blood chambers of the pump
point upward:
Support
LVAD
but
LVAD with P80M-004 and P80M-005
(in/ out exchanged)
Anastomosis of inflow
cannula in
points upward...
Instructions
1. Bring the patient into the Trendelenburg position.
2. Loosen the tube clamps, rinse the cannulas, then lock the cannulas underneath the
incision wound with tube clamps.
3. Connect the prefilled pump first on the inflow site and then on the outflow side. In doing
so, sprinkle sterile saline solution on it to connect the pump approximately without air.
Proceed carefully to prevent damage to the glove or the inner surface of the cannula.
4. Loosen the tube clamps, then de-air the pump(s) and cannulas.
5. Connect the driving tube to the pump.
Caution!
• Ensure the tension-free and bend-free positioning of the cannulas, blood pump(s) and
driving tubes.
End position of the blood pumps with biventricular assistance/ support, left apical
Note
• Then the driving tube is connected to the Ikus. The Ikus is started and the parameters
50 1000002 Rev. 4.9.1
Apex
Apex
Blood chamber
Air chamber
RVAD Atrium Air chamber
LVAD Atrium Air chamber
a
b
c
f
e
d
a RVAD/ right pump (air chamber points upward)
b Inflow cannula of the right atrium
c Outflow cannula to the pulmonary artery
d LVAD/ left pump (blood chamber points upward)
e Inflow cannula of the apex
f Outflow cannula to the aorta ascendens

are adjusted gradually (see page 36).
8.7 Remove the de-airing needle
Remove the de-airing needle
Note
• Only remove the de-airing needle if the blood pump is running and the parameters have
been adjusted (see page 36).
Warning!
• On removing the de-airing needle, never pull on the de-airing tube, but rather on the
de-airing needle itself.
Instructions
1. Loosen the fixation of the de-airing needle on the de-airing nipple [1]. Important: The
ligature itself remains on the de-airing nipple [2]!
2. Pull the de-airing needle out of the de-airing nipple.
Loosen the fixation of the de-airing needle
8.8 Secure the connections
If the patient has been weaned from the HLM and the system is running stably:
Instructions
1. Keep the tube attachment set to hand.
2. Secure the following points with 2 cable tie straps each (position the locking heads
staggered): Inflow cannula on the connector, outflow cannula on the connector, driving
tube to the driving tube connector.
3. Tighten the connections with cable tie pliers.
8.9 Anesthesia
• Sufficient quantities of crossed blood products, fresh frozen plasma and thrombocyte
concentrates should be available at short notice.
• The number of transfusions of foreign blood products should be kept to an absolute
minimum.
• Devices for autotransfusion (e.g. Cellsaver) should be available in the operating room.
• Medication for reducing right ventricular afterload (nitric oxide NO, phosphodiesterase
inhibitor, prostaglandin, etc.) should be available in the operating room.
Monitoring procedure
Intraoperative monitoring corresponds to the usual monitoring for major cardiosurgical
interventions:
• CVL
• Sheath and pulmonary arterial catheter
• Arterial catheter
• ECG
• Pulse oxymetry
1000002 Rev. 4.9.1 51

After the operation
Implantation – Surgical procedure
• Central temperature
• Urinary catheter
Additionally recommended monitoring procedures
• Cardiac output calculation
• Intraoperative transesophageal echo control (location of inflow cannula, valve function,
intracardial shunts, volume status).
Other monitoring procedures (e.g. neuromonitoring) are at the discretion of the
anesthesiologist.
8.9.1 Intraoperative anticoagulation therapy
Preoperative
• Perform thrombelastography to check for hypercoagulative state.
Intraoperative
• While supplying the patient via HLM administration of heparin
• At the end of the operation, administer protamine for the complete antagonization of the
heparin effect and to achieve a normal hemostasis.
8.10 After the operation
Instructions
1. Fill out the implantation log and fax it to Berlin Heart GmbH. For an example, see page
83.
52 1000002 Rev. 4.9.1

9 Intensive care and aftercare
Postoperative anticoagulation therapy
Note
• All information in this chapter constitutes manufacturer recommendations derived from
extensive experience with the EXCOR system and therefore strongly advisable. However,
individual adjustment of the therapy to the patient with due consideration of the
patient’s age, weight, infections or sepsis is essential.
9.1 Postoperative anticoagulation therapy
Patients with EXCOR must receive anticoagulation therapy. In addition, a platelet
aggregation inhibition therapy is recommended (see page 55). The anticoagulation
should begin approx. 12 - 24 h after the operation. So that this can occur without risk to
the patient, a “dry” operation is required, i.e. the patient should experience as little
postoperative bleeding as possible (for infants and young children: no bleeding!).
The setting of the heparin dosage should be checked at regular intervals of 6 h. This can
be done either in the laboratory or with the aid of a PTT fast test (bedside). Once per day,
the coagulation progress should be recorded by means of thromboelastography: The
goal is normal to slightly inhibited global coagulation.
Warning!
• Heparin results in strong thrombocyte activation. Therefore, keep the heparin dose and
the duration of heparin administration as low as possible.
9.1.1 Example: Anticoagulation therapy - Adolescents/adults
Start of therapy
In the first 12 - 24 h postoperatively, no administration of anticoagulants.
After approx. 12 - 24 h, start of heparin administration (i.v.) depending on the
thrombocyte count (>80,000/μl) and bleeding (80s
• If fibrinogen >300g/l: Target PTT 90-100s
1000002 Rev. 4.9.1 53

Postoperative anticoagulation therapy
Intensive care and aftercare
Oral anticoagulation
After complete stabilization of the patient, conversion to a vitamin K antagonist occurs
(target INR: 3.0 to 3.5). The INR value is checked once daily.
Until the target INR is reached, the simultaneous administration of a vitamin K
antagonist and heparin are necessary (duration approx. 4 days). Once the target value is
reached, the heparin is discontinued. If the value subsequently falls below the normal
value, the patient must immediately be supplied with heparin again:
INR 3.0 to 3.5 Vitamin K antagonist, p.o.
INR 2.2 to 2.9 0.3 ml/kg 2x/d low molecular weight heparin, s.c.
INR 80,000/μl) and bleeding (for infants and young children: no bleeding!).
Note
• If th patient was treated with ECMO for a longer period of time: According to the bleeding,
PTT, thromboelastography and platelet aggregation test, heparin administration begins
approx. 24 h postoperatively or later.
PTT
PTT should be performed every 6 h.
• At a thrombocyte count of 100,000/μl, the target PTT is 60-80s
Thromboelastography
Thromboelastography once per day. If necessary, the result makes a target PTT of
80s necessary:
• If the thrombocyte function is substantially disturbed (e.g. due to hemofiltration):
Target PTT 300,000/μl:
Target PTT >80s
• If fibrinogen >300g/l: target PTT 90-100s
Oral anticoagulation
After complete stabilization of the patient, conversion to a vitamin K antagonist occurs
(target INR: 2.8 to 3.5), initial dose 0.2 mg/kg/d. The INR value is checked once daily.
Until the target INR is reached, the simultaneous administration of a vitamin K
antagonist and heparin are necessary (duration approx. 4 days). After reaching the target
value, heparin is discontinued. If the value subsequently falls below the normal value,
the patient must immediately be supplied with heparin again:
INR 2.8 to 3.5 Vitamin K antagonist, p.o.
INR 2.0 to 2.7 Age-specific dose, s.c.
INR

Postoperative platelet aggregation inhibition therapy
Note
• Many types of baby food contain high doses of vitamin K.
• The accuracy of the INR measurement of a laboratory varies by 0.2; between different
laboratories, it varies by up to +/-0.7.
If the INR value does not stabilize, then instead of heparin and/or a vitamin K
antagonist, low molecular weight heparin (Depending on the INR, ACT or PTT, start
administration of LMW heparin with an initial dose of 1mg/kg/2xd (every 12 h; applies
for enoxaparin ® ). The target dose varies according to the preparation used. Every
6 to 8 h after administration of LMW heparin, antifactor Xa (therapeutic range 0.6 to
0.8 U/ml) is checked.
9.1.3 Monitoring the blood values
The following blood values are monitored daily during the first week postoperatively:
• Antithrombin III level (target value > 75%)
• Fibrinogen
• D-dimers
• Leukocytes
• CRP
Note
• Every infection activates the coagulation system. Therefore, careful and regular
monitoring of the blood values is essential. If necessary, appropriate corrective action
should be taken immediately.
• Antithrombin is often reduced in infants and must be substituted accordingly.
9.2 Postoperative platelet aggregation inhibition therapy
The dose of the platelet aggregation inhibition substances acetylsalicylic acid and
dipyridamol should be adjusted on an individual basis. This can be monitored by means
of thrombocyte mapping or a platelet aggregation test. Since individual patients react
differently to platelet aggregation inhibition substances, the optimal dose should
minimize the risk of occurrence of thrombo-embolic complications (in the case of
underdose) or bleeding complications (in the case of overdose).
Start of therapy
• After removing all drainage shunts
• No earlier than days 2-4 postoperatively
• If the thrombocyte count is >100,000/μl
Monitoring frequency
• Week 1 postoperatively: 1x daily
• Week 2 postoperatively: every two days
• Week 3 postoperatively: 2x per week
• Subsequently: 1x per week
Note
• Some medications used to treat cardiac insufficiency have a positive effect on
anticoagulation and in particular on platelet aggregation inhibition. We recommend:
• Beta blockers
• ACE inhibitors
• Psychotropics such as serotonin reuptake inhibitors
• Inflammation parameters in patients with VAD oftentimes exceed the normal
thresholds. Omega-3 fatty acids have an anti-inflammatory effect (DHA, EPA; 3g/d) and
also lead to resistance of the thrombocyte membrane against premature activation.
• Antioxidants also have an anti-inflammatory effect.
1000002 Rev. 4.9.1 55

Antibiotic therapy
Intensive care and aftercare
9.2.1 Example: Platelet aggregation inhibition therapy - Adolescents/adults
Platelet aggregation inhibition
The required daily dose of the platelet aggregation inhibitor acetylsalicylic acid (Aspirin ® ,
75 to 500 mg/d, p.o.) is divided into two daily doses (morning and evening) to
counteract the strong thrombocyte neoformation.
Sufficient inhibition by Aspirin ® is achieved if, in the platelet aggregation test,
arachidonic acid is reduced to < 30% and epinephrine to 40-50%.
Platelet adhesion inhibition
At a thrombocyte count of > 150,000/μl and/or higher amplitude in thromboelastography
(> 80mm): Start of administration of the platelet adhesion inhibitor dipyridamol (150 to
600 mg/d).
9.2.2 Example: Platelet aggregation inhibition therapy - EXCOR Pediatric
Platelet aggregation inhibition
The required daily dose of the platelet aggregation inhibitor acetylsalicylic acid (Aspirin ® ,
initial dose 1 mg/kg/d, p.o.) is divided into two daily doses (morning and evening) to
counteract the strong thrombocyte neoformation.
Sufficient inhibition by Aspirin ® is achieved if, in the platelet aggregation test,
arachidonic acid is reduced to < 30% and epinephrine to 40-50%.
Platelet adhesion inhibition
At a thrombocyte count of > 150,000/μl and/or higher amplitude in thromboelastography
(> 80mm): Start of administration of the platelet adhesion inhibitor dipyridamol
(4 mg/kg/d).
9.3 Antibiotic therapy
Recommendation
• Perform the therapy over 7 days.
• A perioperative antibiotic prophylaxis with good staphylococcus coverage
(e.g. cephalosporin, 2nd generation).
• In the event of signs of local infection in the area of the transcutaneous passage or
evidence of systemic infection: targeted antibiotic therapy after pathogen isolation in all
accessible media (hemoculture, swab).
• In the event of a cannula infection, perform a long-term oral antibiotic therapy, because
otherwise repeated infection flareups may occur.
9.4 Wound care
The incision wound sites must be treated like open wounds. Wound care should be
performed in the inpatient area, and always by the same person. If the patient is
discharged to outpatient care, the patient and family members must be instructed
accordingly. The risk of infection can only be minimized by practicing careful wound care.
Cautionary measure
• For wound care, wear sterile disposable gloves, hood and face mask.
Material (for biventricular access):
• 1 pair of disposable gloves
• 1 hood
• 1 sterile face mask
• 1 pair of sterile disposable gloves
• 1 sterile drape (75x90 cm)
• Disinfectant according to prescription
• 8 sterile-packaged wound plasters (approx. 7x5 cm)
56 1000002 Rev. 4.9.1

• 4 sterile-packaged gauze compresses (each approx. 10x20 cm)
• 4 Metalline ® drain compresses (approx. 6x7 cm) or corresponding product
Removing the old dressing material
Instructions
1. Unpack all materials required for wound care and lay them out on a sterile drape.
2. Put on disposable gloves and remove old dressing material.
3. Remove disposable gloves and put on sterile disposable gloves.
4. Examine the incision wound sites of the cannulas and take corrective action if necessary
in the event of changes.
5. Clean the skin with disinfectant in the area of the cannula incision wound sites.
6. Clean the incision wound sites. To do so, fold sterile compresses soaked in disinfectant
lengthwise and move them back and forth directly on the incision wound site.
7. Clean the cannulas on the upper side and underside.
Creating the new dressing
Instructions
1. Place a Metalline ® drain compress around each cannula (from right to left, with the slit
facing upward).
2. Fix Metalline ® drain compresses with sterile plaster above the cannula. Fix the outer
compresses first, then the inner compresses.
1
3. Slide a gauze compress folded lengthwise underneath the two left cannulas. The open
side of the folded compress then faces in the direction of the incision wound site.
Position the cannulas by pulling moderately on the compress.
4. Fold the left end of the compress diagonally upward to the right and fix it with sterile
plaster.
5. Fold the right end of the compress diagonally upward to the left and fix it with sterile
plaster.
3 4 5
2
Wound care
1000002 Rev. 4.9.1 57

Regular inspection of blood pump(s) and cannulas
Intensive care and aftercare
6. Perform the same treatment for the two right cannulas. A load-relieving cushioning of
the four cannulas has now been created.
7. Cover everything generously with sterile gauze compresses.
6 7
8. Fix the upper part of the dressing with sterile plaster.
9. With one strip of sticking plaster in each place, close the dressing on the right and left
underneath the cannulas and between the cannulas.
8 9
Recommendation
• The cannulas must not be stuck together with plaster. Over time, residues of adhesives
lead to contamination of the cannulas and an increased risk of infection.
Frequency of change of dressing
• Wound dry and infection-free: Wound care and change of dressing initially once daily,
then if the wound conditions are normal, every two days after 10-14 days.
• Wound infected: Wound care and change of dressing twice a day.
9.5 Regular inspection of blood pump(s) and cannulas
Monitoring frequency
• First three days postoperatively: hourly
• Inpatient care: three times daily
Warning!
• Check at least three times a day by visual inspection over several pump cycles that the
blood pump(s) is/are filling and emptying completely. If a pump does not fill and/or
empty completely, then corresponding corrective action must be taken.
• On EXCOR blood pumps with a 10 ml stroke volume, due to the low air volume moved,
the message “Left / right pump is filling insufficiently” is not generated in certain
circumstances. Therefore, pay particular attention on this pump size to the membrane
movement and the complete filling and emptying of the blood chamber.
Note
• Any person entrusted with the care of an EXCOR patient must be capable of performing
a visual inspection, evaluating the filling of the blood pump(s) and detecting deposits.
58 1000002 Rev. 4.9.1

9.5.1 Visual inspection: Filling/ ejecting of the blood pump
Regular inspection of blood pump(s) and cannulas
A blood pump fills and empties optimally if, in the end-of-systole and end-of-diastole
positions, the membrane surface is completely smooth. Check over several pump cycles
that the pump(s) is/are filling and emptying completely. If a pump does not fill and/or
empty completely, then corresponding corrective action must be taken.
Corrective action
• For each blood pump: Check the position and condition of the driving tube and cannulas.
(Inflow deterioration due to breaking off of the cannulas/driving tubes is rather
uncommon.)
• For each blood pump: Check the membrane movement.
• Medicinal monitoring of the patient: Check CVP; check mean arterial pressure and adjust
if necessary.
• Check volume situation:
• Quantity of bleeding
• Increased elimination (diuretics?)
• Tamponade
• Important: Increasing the negative pressure cannot cause any major
improvement if a corresponding volume supply is not available.
• For LVAD: Pay attention to the right heart function.
Adjusting the parameter values
Only adjust the parameters if the above-mentioned corrective action has no effect or for
• Mobilization of patient: Adjustment of the left and right systolic pressure. Do not reduce
pressures which have been increased while the patient is lying down.
• Signs of cardiac insufficiency: With good membrane movement, a decline in urine
elimination, lactate increase and shortness of breath must be observed. In this case,
increase the rate and adjust other settings. If necessary, consider replacing the pump
(larger volume).
Instructions
1. Move the cursor with ← / → to the desired field in the parameter table. The active field
is colored underneath.
2. Adjust the value with ↓,↑/ / , then confirm with . The system
works with the new value.
Cautionary measure
• Confirm each changed parameter value individually with . The system only
applies the changed values after this confirmation.
9.5.2 Visual inspection: Deposits
At least three times per day, check the blood pump(s) for deposits (fibrin, thrombi).
Record any findings in the “EXCOR Pump Log” (standard form see page 94). If deposits
are beginning: Check the anticoagulation therapy!
1000002 Rev. 4.9.1 59

Regular inspection of blood pump(s) and cannulas
Intensive care and aftercare
Inspection of the pump areas with blood contact
1 11 1 transition inflow cannula - inflow connector
2 Only on pumps with PU valves: Inflow stub in front of inflow valve
2 10
3 inflow valve
4 inflow stub behind inflow valve
3 9
5 area between inflow and outflow stubs
6 remaining area of blood chamber
5
7 transition blood chamber - membrane
4 8
(directly above the reinforcement ring)
6
8 outflow stub in front of outflow valve
9 outflow valve
10 Only on pumps with PU valves: Outflow stub behind outflow valve
7
11 transition outflow connector - outflow cannula
Diagram of EXCOR blood pump (supervision of blood chamber)
Recommendation
• When performing the inspection, illuminate the blood chamber of the pump with a
flashlight. This makes it easier to detect deposits.
Corrective action
• If deposits are beginning: Check the anticoagulation therapy and adjust it if necessary.
• Floating deposits in the pump: Replace the pump!
9.5.3 Inspection via the monitoring program
• Log the drive parameters and adjust them if necessary.
• Goal: Complete filling and emptying of the pump in each cycle, lowest possible diastolic
pressures.
Recommendation
• Log the parameter values once per day.
• To log the parameters, use the standard form “EXCOR parameters” (standard form see
page 95).
60 1000002 Rev. 4.9.1

10 Explantation
10.1 Bridge-to-Transplant (BTT)
Bridge-to-Transplant (BTT)
Note
• When planning and timing the transplantation, be aware that massive adhesions may
exist in the transplant recipient.
Removing the donor organ
Recommendation
• Leave a sufficiently long segment of the aorta and pulmonary artery on the donor organ
so that it is possible to do without the sections applied through the cannula anastomosis.
Switch off the Ikus
Instructions
1. Supply the patient via the HLM.
2. In the monitoring program, select the option “Drive off”, then confirm with .
3. Confirm the decision in the dialog window with or . The system stops operating
immediately and writes an operating log.
4. Pull the driving tube(s) out of the connector(s). To do so, grab the plug by the ribbed
plug body and pull it out of the connector.
5. Seal the driving tube connection sockets with seal plugs.
6. Wait until the log has been prepared. When the message “Switch off drive at the key
switch” appears, exit the monitoring program with , then confirm the decision in
the dialog window with or .
7. In the start menu, select “End” (), then switch off the laptop.
8. When the batteries are completely charged (see below), switch off the Ikus. In addition,
set the key switch to OFF [O].
Warning!
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN -
even when the Ikus is switched off! The only exception is battery mode: Before switching
to battery mode, move the power switch (mains power switch) to the OFF/Aus [O]
position. Immediately after restoring the power connection, move the power switch back
to the ON/Ein [I] position.
Caution!
• Always follow the sequence described above. Always switch off the Ikus at the key switch.
• Only switch off the Ikus when the batteries are completely charged. To do so, leave the
Ikus switched on until all the yellow LEDs light up. Then switch off the Ikus at the key
switch.
Remove the VAD cannulas
Instructions
1. Disconnect the cannulas.
2. Disconnect the pump from the cannulas.
3. Remove the cannulas. Stitch over the insertion sites on the atrium.
The following steps correspond to those of a primary orthotopic transplantation.
1000002 Rev. 4.9.1 61

Weaning (Bridge-to-Recovery, BTR)
Explantation
10.2 Weaning (Bridge-to-Recovery, BTR)
10.2.1 Explantation with univentricular support
Procedure identical to BTT. Stitch over the insertion sites of all cannulas.
10.2.2 Explantation with biventricular assistance/support
Stop the right pump
Instructions
1. Select the option “Pause right”, then confirm with . Confirm the decision in the
dialog window with or . The right pump stops. You arrive at the view “Pump size
and single-step mode”. The cursor is on OK.
2. Pull the driving tube of the right pump out of the connector on the Ikus. Close the
connector with the seal plug.
3. Confirm with . The Ikus continues to work. You arrive at the normal view.
Switch off the Ikus
Instructions
1. Supply the patient via the HLM.
2. In the monitoring program, select the option “Drive off”, then confirm with .
3. Confirm the decision in the dialog window with or . The system stops operating
immediately and writes an operating log.
4. Pull the driving tube(s) out of the connector(s). To do so, grab the plug by the ribbed
plug body and pull it out of the connector.
5. Seal the driving tube connection sockets with seal plugs.
6. Wait until the log has been prepared. When the message “Switch off drive at the key
switch” appears, end the monitoring program with , then confirm the decision in
the dialog window with or .
7. In the start menu, select “End” (), then switch off the laptop.
8. When the batteries are completely charged (see below), switch off the Ikus. In addition,
set the key switch to OFF [O].
Warning!
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN -
even when the Ikus is switched off! The only exception is battery mode: Before switching
to battery mode, move the power switch (mains power switch) to the OFF/Aus [O]
position. Immediately after restoring the power connection, move the power switch back
to the ON/Ein [I] position.
• Always follow the sequence described above. Always switch off the Ikus at the key switch.
• Only switch off the Ikus when the batteries are completely charged. To do so, leave the
Ikus switched on until all the yellow LEDs light up. Then switch off the Ikus at the key
switch.
• Always keep unused driving tube connectors closed.
62 1000002 Rev. 4.9.1

11 Error messages and corrective action
This chapter lists all the Ikus error messages and informs you of the appropriate
corrective action to be taken.
• For each message, proceed as exactly as described here.
• Always remain calm!
• Be particularly vigilant as long as there is a message and its cause has not been
eliminated!
• For all EXCOR-related questions, call the hotline 0700-berlinheart (+49(0)700 23754643).
If an error message exists,
• An acoustic signal sounds (continuous tone).
• The visual signal display on the grip lights up.
• The field “Alarm off” in the monitoring program has a red border.
• A text appears in the message window of the monitoring program informing you about
the time of occurrence, the type of error and the appropriate corrective action to be
taken. Important: You must always follow these instructions! Some more complex error
messages also contain an 8-digit or 16-digit binary code which allows Berlin Heart
service to clearly identify the cause of the error.
What should you do if an error message occurs?
• Check the status of your patient!
• Check by visual inspection over several pump cycles that each pump is/are filling and
emptying!
• Take the corrective action corresponding to the error message and acknowledge the
message.
Acknowledging the error message
Instructions
1. Acknowledge the error message by pressing the button on the grip. The acoustic signal
stops. The field “Alarm off” in the monitoring program lights up in red.
2. Read the message in the message window carefully. Pay attention to the instructions in
the message text.
3. Take the corresponding corrective action immediately.
4. Then acknowledge the message in the monitoring program. To do so, move the cursor
to the field “Alarm off”, then confirm with . Otherwise, the acoustic alarm
sounds again after ten minutes.
Note
• With some error messages, a reference to system 1, 2 or 3 appears in the monitoring
program. This means the following allocation:
• System 1 (left): system connected to the red connector
• System 2 (right): system connected to the blue connector
• System 3 (backup): Backup system
The system designations left and right relate to the system-internal allocation of the
pneumatic systems and not to the left or right pumps.
• All messages are saved together with their time of occurrence in the log file.
• With some error messages, the cause of the error clears up spontaneously after a short
time. Then a corresponding elimination message appears (e.g. “Please check the left
tube and pump!” - “Left: Tube and pump OK”).
Warning!
• Messages are only displayed when the monitoring program is running. If the monitoring
program has been exited, only an acoustic signal and the indicator lamp on the grip of
the Ikus indicate the existence of messages. There is no way to determine the nature of
the message.
• If the monitoring program has been exited, no actual events are stored and the log files are
1000002 Rev. 4.9.1 63

Batteries discharged; battery mode not possible
Error messages and corrective action
incomplete. Therefore, only end the monitoring program when it is absolutely necessary
(for example, to set new user profiles)! Then restart it again as soon as possible!
11.1 Batteries discharged; battery mode not possible
The batteries have become discharged during running mains power operation.
Warning!
• You must continue to operate the Ikus on mains power! There is a threat of total failure
if battery mode is used!
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: Supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
11.2 Updating the parameter block failed
The Ikus cannot store the changed parameter values in the internal system memory. The
driving unit continues to work with the changed values; however, in the case of an
internal reset triggered by the Ikus, the old values would become valid again.
Notify hotline! +49(0)30 8187 2772
Instructions
1. Check the parameter values regularly. After a reset, if the Ikus continues to work with the
old parameter values: Readjust the parameter values.
Note
• During a reset, the Ikus emits a short acoustic alarm.
11.3 The acoustic alarm is not correctly detected
If, within 8 seconds, the message Acoustic alarm: OK appears,
the Ikus is working perfectly. No further corrective action is necessary.
If the message Acoustic alarm: OK does not appear within 8 seconds,
the alarm circuit is defective. A possible error might not be detected.
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Important: Do not operate the Ikus without supervision!
3. If possible,: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: Supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
64 1000002 Rev. 4.9.1

11.4 Alarm circuit fault – horn remains off (or on)
Alarm circuit fault – horn remains off (or on)
During the “Alarm circuit self-test” or in the event of an alarm, an error in the alarm
circuit is determined.
Depending on the error, this message appears:
• “Alarm circuit fault – horn remains off”
• “Alarm circuit fault – horn remains on”
• “The acoustic alarm was not correctly detected”
Warning!
• In the event of an alarm, the Ikus does not generate an acoustic signal or generates an
incorrect acoustic signal. Follow the messages in the message window carefully and pay
attention to the visual signal display in the display and operating panel. Do not operate
the Ikus without supervision!
Notify hotline! +49(0)30 8187 2772
11.5 Connect the driving tube
Instructions
1. Check the driving tube and plug.
2. Is the plug position incorrect? Correct the plug position. To do so, grab the plug by the
ribbed plug body and pull it out of the connector, then insert it into the connector again.
Check that the plug is firmly seated. To do so, pull the plug above the ribbed plug body.
Never pull on the tube!
3. Driving tube fault: Replace the driving tube.
11.5.1 Replace the driving tube
The driving tubes (red/blue) have a maximum lifespan of 500 days (see section 13.2:
"Technical specifications", p. 89). Then they must be replaced.
Recommendation
We recommend also replacing the driving tubes (in univentricular mode red or blue)
each time the pump is replaced, unless the last replacement was very recent.
Warning!
• Replacing a driving tube requires stopping the pump briefly. If the left driving tube is
replaced in biventricular mode, the right pump must also be stopped for the duration of
the replacement to prevent overloading of the pulmonary circulation (risk of pulmonary
edema).
Material
• 1 Driving tube, red or blue
• 1 Tube attachment set from accessory set (cable tie strap, cable tie pliers)
Instructions
1. Carefully cut through the cable tie strap on the faulty driving tube.
2. If necessary, enter the user number and password in the monitoring program, then
confirm with .
3. Select the option “Drive pause”, then confirm with . Confirm the decision in the
dialog window with or . The Ikus stops.
4. As soon as the pump stops, remove the faulty driving tube from the pump.
5. Connect the new driving tube to the pump. To do so, slide the tube carefully onto the
driving tube connector.
6. Pull the faulty driving tube out of the connector on the Ikus. To do so, grab the plug by
the ribbed plug body and pull it out of the connector.
1000002 Rev. 4.9.1 65

Do not operate the driving unit without supervision!
Error messages and corrective action
7. Connect the new driving tube to the connector that is now free. The plug snaps audibly
into place. Check that the plug is firmly seated. To do so, pull the plug above the ribbed
plug body. Never pull on the tube!
8. The view “Operating mode” appears in the monitoring program. Select Univentricular or
biventricular, then confirm the desired operating mode with . In biventricular
mode, the view “Pump size and single-step mode” follows. In univentricular mode, the
connector seal test follows first, ad then the view “Pump size and single-step mode”.
9. Confirm with .
10. The system restarts with the set parameters.
11. Observe the pump filling. If necessary, adjust the parameters.
12. Secure the new driving tube on the pump side with cable tie straps.
11.6 Do not operate the driving unit without supervision!
Note
• This message appears if, when the message “Left/right flow sensor defective. Contact
Service department!” on page 69 exists, you do not replace the faulty Ikus with an intact
Ikus.
Warning!
• Only operate the Ikus under supervision!
11.7 Backup operation left/right
The left or right pneumatic system has failed. The corresponding pump is operated by
the backup system.
Notify hotline! +49(0)30 8187 2772
11.8 Please check the tube and the left/right pump
The Ikus has detected an excessively high/low flow.
Warning!
• On EXCOR blood pumps with a 10 ml stroke volume, due to the low air volume moved,
the message “Check the left / right tube and pump” is not generated in certain
circumstances. Therefore, pay particular attention on this pump size to the membrane
movement and the complete filling and emptying of the pump(s).
Instructions
1. Check the driving tube and cannulas: Is there an obstruction due to bends? Ensure an
unobstructed flow.
2. Check the driving tube and plug: Is the plug position incorrect? Correct the plug
position. Is the driving tube faulty? Replace the driving tube (see Section 11.5.1, p. 65).
3. Adjust the parameters if necessary.
4. Consider changing the cannula position if necessary.
5. Evaluate the hemodynamics of the patient (volume, MAP, PAP, CVP, etc.).
11.9 Fault: ()
Notify hotline! +49(0)30 8187 2772
Note
• If you pass on the error code directly (via phone, fax) to service: Always state all 16 digits!
• Service may request that you read out and send the log files. see Section 12.7 “Read out
the log files” on page 83.
66 1000002 Rev. 4.9.1

Throttle valve error in system 1 (or system 2 or 3), please wait...
11.10 Throttle valve error in system 1 (or system 2 or 3), please wait...
In an active system, the Ikus has detected a throttle valve error (throttle: internal
subassembly for pneumatic test) and is switching to backup operation (see Section 11.7,
p. 66).
Notify hotline! +49(0)30 8187 2772
11.11 Pressure error/ time error in system 1 (or system 2 or 3)
The air volume moved by the Ikus per cycle or the required pressure has changed. The
Ikus checks whether an internal system error exists (e.g. faulty compressor) or whether
an external error exists (e.g. driving tube not connected/ leaks air).
Note
• During the test phase, the blood pump of the corresponding system stops (max. 15 s).
If the Ikus detects a pneumatic error,
the Ikus switches to backup operation and the message “Backup operation left/right”
appears (see Section 11.7, p. 66) and the request to contact service.
Notify hotline! +49(0)30 8187 2772
If the Ikus detects an external error,
the message “Please connect driving tube” appears (see Section 11.5, p. 65).
If the main processor cannot complete the test phase,
the backup processor generates the message “Backup processor reports testing
malfunction” (see Section 11.12.4, p. 68).
In this case, proceed as described in the respective paragraphs.
Warning!
• The blood pump driven by the tested system has been stopped since the start of the test.
Take action immediately!
11.12 Backup processor...
11.12.1 ...flow measurement deviation on the left (or right)
The main processor has detected a flow error. This message only appears in conjunction
with the message “Please check the tube and the left/right pump” on page 66.
Immediately take the corrective action described there.
Notify hotline! +49(0)30 8187 2772
11.12.2 ...is reporting abnormal measurements on the left (or right)
The main and backup processors have arrived at different results.
If this message appears only once within eight seconds,
no further corrective action is necessary.
If the message appears again:
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
1000002 Rev. 4.9.1 67

FATAL: Battery failure! Inform Service urgently!
Error messages and corrective action
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: Supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
11.12.3 ...is reporting the error: Flow measurement on the left (or right)
The backup processor has detected a flow error, but the main processor has not detected
a flow error.
Instructions
1. Check the filling and emptying of the blood pump(s).
2. Check the plausibility of the measured values.
3. Reset all of the parameter values. In addition, log out of the monitoring program and then
log back into it. Navigate the cursor with ← / → to the desired field, adjust the value with
↓,↑/ / , then confirm with . The system works with the new value.
If the message appears again:
Notify hotline! +49(0)30 8187 2772
11.12.4 ...is reporting a checking error
The main processor cannot end the test phase to check the system after the error
message “Pressure error/time error in system 1 (or 2 or 3)” (see Section 11.11, p. 67).
Warning!
• The blood pump driven by the tested system has been stopped since the start of the test
phase. Take corrective action immediately!
Instructions
1. Evaluate the status of the patient.
2. Immediately ensure the supply of the patient by means of a replacement Ikus (see
Section 12.4, p. 80) or a manual pump (see Section 12.5, p. 81).
Notify hotline! +49(0)30 8187 2772
11.13 FATAL: Battery failure! Inform Service urgently!
Warning!
• You must continue to operate the Ikus on mains power! There is a threat of total failure
if battery mode is used!
Instructions
1. In the case of battery mode: Connect the Ikus to the mains power supply immediately!
2. Check the status of the patient.
3. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
4. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: Supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
5. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
68 1000002 Rev. 4.9.1

11.14 Error: no data/no reaction from the control processor
Error: no data/no reaction from the control processor
In the event of the simultaneous failure of both control processors or the failure of the
power supply, the Ikus cannot generate a specific error message in the message window.
Instructions
1. Check the status of the patient.
2. Evaluate the failure scenario:
• no alarm, but the Ikus continues to function: no communication between the
control processors or between the control processors and the laptop
• optical and acoustic alarm, and the Ikus is working in emergency pulse mode: both
control processors are defective
• The Ikus is halted; acoustic alarm only: defective power supply
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80).
If no replacement Ikus is available and the Ikus is running: check the filling and emptying of
the blood pump(s), and monitor the function of the Ikus. Do not operate the Ikus
without supervision!
If no replacement Ikus is available and the defective Ikus is halted: supply the patient with
the manual pump (see Section 12.5, p. 81)!
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
11.15 The error is only detected by the active (or passive) controller
Only the active (or passive) controller has detected an error. This message only appears
in conjunction with an additional, actual error message. Immediately take all of the
necessary corrective action for this second message.
Notify hotline! +49(0)30 8187 2772
11.16 Left/right flow sensor defective. Contact Service department!
The corresponding flow sensor is defective. Although the Ikus continues to run, the
excessively low flow would not be detected - possibly due to the snapping off of a cannula
or the driving tube.
Warning!
• Do not operate the Ikus without supervision!
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
Note
• If the defective Ikus is not replaced, this message appears cyclically at 10-minute intervals.
1000002 Rev. 4.9.1 69

No internal communication
Error messages and corrective action
11.17 No internal communication
The active control processor and the backup control processor cannot communicate
with each other. Possible causes to be considered include the lack of power supply or a
severe system error.
Instructions
1. Check the status of the patient.
2. Check the charge level indicator of the batteries. In the case of battery mode: Connect
the Ikus to the mains power supply. Ensure that the power switch (mains power switch)
is set to ON/EIN.
Notify hotline! +49(0)30 8187 2772
11.18 Emergency operating mode
11.18.1 Univentricular
The pump is driven by the last intact pneumatic system.
The pneumatic system continues operating with the set parameters. The parameters
may now be adjusted. However, it is not possible to switch to biventricular mode.
Warning!
• No system is available any longer as a redundancy. In the event of the failure of the intact
pneumatic system, there is a risk of stoppage of the Ikus.
Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
11.18.2 Biventricular
Both pumps are jointly driven by the last intact pneumatic system.
The pneumatic system works with fixed parameters (synchronous mode, 250 mmHg
systolic pressure, -100 mmHg diastolic pressure, 70 bpm, relative systolic duration
40 %). These parameters cannot be changed.
Possible causes:
• Two of the three pneumatic systems are faulty.
• The Driving Unit Ikus was run for too long in battery mode (message: “Emergency
operating mode due to empty batteries - threat of total failure!”). The Ikus could no
longer construct any reliable values. To rule out a fault in the control, the Ikus has
switched to the backup system and the backup control processor. The message “Backup
processor started” is displayed.
Warning!
• No system is available any longer as a redundancy. In the event of the failure of the intact
pneumatic system, there is a risk of stoppage of the Ikus.
Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
70 1000002 Rev. 4.9.1

11.19 Problem:
If this message appears during the start test: see “Error messages during the start test” on
page 73.
If this message appears outside of the self-test,
a serious problem exists.
The Ikus has detected a serious problem.
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
Notify hotline! +49(0)30 8187 2772
11.20 Processor failure. Contact service!
One of the processors has failed. Immediately do the following:
Notify hotline! +49(0)30 8187 2772
11.21 The self-test is not ended by the passive processor
The passive processor was unable to end the self-test of the alarm circuit.
If, within 8 seconds, the message alarm circuit OK appears,
the Ikus is working perfectly. No further corrective action is necessary.
If the message alarm circuit OK does not appear within 8 seconds,
the alarm circuit is defective. A possible error might not be detected.
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80). If no replacement Ikus is available: supply the patient, if
necessary (in the event of a failure malfunction of the defective Ikus), by means of the
manual pump (see Section 12.5, p. 81)!
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
11.22 System 1 (or 2) is faulty
The corresponding pneumatic system is faulty.
In normal operation
The backup system (system 3) is activated.
Notify hotline! +49(0)30 8187 2772
In backup operation
The Ikus is working in emergency operating mode.
Problem:
1000002 Rev. 4.9.1 71

System 3 is faulty
Error messages and corrective action
Notify hotline! +49(0)30 8187 2772
11.23 System 3 is faulty
The backup pneumatic system is faulty.
In normal operation
The Ikus firstly continues working normally. In the event of the failure of another
pneumatic system, the Ikus would start working in emergency operating mode.
Notify hotline! +49(0)30 8187 2772
In backup operation
The Ikus is working in emergency operating mode.
Notify hotline! +49(0)30 8187 2772
11.24 System has reached maximum capacity
The information message “System 1 (or system 2 or system 3) has reached maximum
capacity!” appears if, in the current pump cycle, the compressed air constantly generated
by the processor cannot achieve the pressure required to meet the set parameters.
The message may have the following causes:
• Extreme parameter values (extremely high values or extremely low values)
• Restricted performance capability of the pneumatics (maintenance required)
• Malfunction in the system
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s), and monitor the function of the
Ikus. Do not operate the Ikus without supervision!
3. Compared the set target parameter values with the achieved actual values. In the event
of deviation from high set values: Reduce the rate if necessary and/or vary the relative
systolic duration, reduce the driving pressure parameters.
4. By scrolling through the message window, check whether the message has already
occurred previously.
5. Observe whether the message occurs again.
If the message occurs several times in the course of 24 h:
Notify hotline! +49(0)30 8187 2772
Note
• Damage to the Driving Unit Ikus by exceeding maximum capacity is technically
impossible!
• In the case of high set parameter values, a further increase in the rate or the driving
pressures should be avoided. Otherwise, the Ikus performs a test phase if necessary,
which involves a short stoppage of the blood pump(s).
• The information message “System has reached maximum capacity!” is not
accompanied by an acoustic signal.
72 1000002 Rev. 4.9.1

11.25 Temperature sensors:
Temperature sensors:
In most cases, overheating of the Ikus is due to external factors like direct heat
irradiation (e.g. caused by direct sunlight, heating, etc.). Overheating due to internal
factors is possible but uncommon.
Warning!
• Never use water or other fluids to cool the Ikus!
Instructions
1. Determine whether internal or external factors have caused the overheating. Is the Ikus
exposed to direct heat irradiation? Is the ambient temperature is too high?
2. If possible, change the ambient conditions. (Move the Ikus away from heating, etc.).
Ensure adequate ventilation. Confirm the message. It takes a few minutes for the Ikus to
cool down. Confirm the message again if necessary.
If external factors can be excluded as the message cause...
Note
• When transmitting the error code to Berlin Heart service (by phone or e-mail). Always
transmit all eight digits!
• Berlin Heart service may ask you to read out the log files and send them to Berlin Heart
(see page 83).
11.26 Faulty connection to the laptop
This message informs you that the communication between the control processors and
the monitoring program has been temporarily interrupted. This occurs if the monitoring
program is exited, for example to administer user numbers and passwords. Since this
message only appears when the communication is re-established, this message does
not require any corrective action to be taken.
11.27 Error messages during the start test
11.27.1 Battery mode test skipped due to battery problem
The charge level of the batteries is too low to permit battery mode.
Instructions
1. Operate the Ikus on mains power. Battery mode is only possible if all of the yellow LEDs
are illuminated.
11.27.2 Faulty connection to the laptop
This message informs you that the communication between the control processors and
the monitoring program has been temporarily interrupted. Since this message only
appears when the communication is re-established, this message does not require any
corrective action to be taken.
1000002 Rev. 4.9.1 73

Error messages during the start test
Error messages and corrective action
11.27.3 Additional messages during the start test
If the Ikus detects an error during the start test, one of the following messages appear
in the message window depending on the nature of the error:
• Problem: Batteries have very different charge levels.
• Problem: Battery controller.
• Problem: Defective mains power supply. Please inform Service.
• Problem: Laptop! Please inform Service.
• Problem: Power circuit - inform Service.
• Problem: Power supply sensor defective. Inform Service.
• Problem: Power supply voltage - check mains connection.
• Problem: Defective mains power supply. Please inform Service.
• Problem: Error in WR2/ circuit board.
• Problem: Circuit 1 defective. Inform Service.
• Problem: Circuit 2 defective. Inform Service.
• Problem: WR1 does not switch. Inform Service.
Restart the Ikus
Instructions
1. According to the display:
If necessary: enter to read message; go back by pressing .
Essential: enter or to exit the monitoring program. A second window appears.
2. Second window: According to the display, select the option . The monitoring
program writes a log file and is terminated. Wait until the message “You can now switch
off the drive.” appears.
3. Switch off the key switch and then switch it back on again.
If the Ikus now ends the start test without a message:
Start up the Ikus.
If one of the above messages appears again:
Do not start up the Ikus.
Notify hotline! +49(0)30 8187 2772
74 1000002 Rev. 4.9.1

12 Detecting and eliminating problems
Possible problems
Problem Cause / Corrective action
Visible defects on the Ikus Inform 0700-berlinheart
Visible defects on the pump Replace the pump: see page 75
For all questions / uncertainties:
Notify hotline! +49(0)30 8187 2772
Replace the blood pump(s)
Deposits in the pump If deposits are beginning: Check the anticoagulation therapy and adjust it if necessary
In the case of floating deposits: Replace the pump: see page 75
The pump fills/empties
incorrectly
Ikus: Curves are at a
standstill, parameters
cannot be adjusted
Curves are still at a
standstill
Audible and visible alarm
from the Ikus, message
“Error: no data from the
control processor” or
“Error: no reaction from the
control processor”
Note
• If you must contact Berlin Heart service due to a malfunction: If possible, use the
“EXCOR VAD emergency log” (standard form see page 96). This log records relevant
information that can contribute to identifying the malfunction.
12.1 Replace the blood pump(s)
Necessary if
• a visible defect exists in the pump(s)
• floating deposits are found in the pump(s)
Recommendation
Evaluate the status of the patient and the hemodynamics
Adjust the parameters if necessary
Consider changing the cannula position; see page 66
Possible causes
- Communication error between control processor and laptop
- Batteries supply insufficient current
- Electronics have failed (main and backup control processors)
What should be done?
Switch the laptop off and on, wait during the start process, then restart the
monitoring program. Important: The Ikus continues operating during this time with
the set parameters!
The Ikus works in emergency pulse mode (synchronous mode, systolic pressure
200 mmHg, diastolic pressure -40 mmHg, rate 90 bpm, relative systolic duration 40%).
Inform 0700-berlinheart. Restart the Ikus after discussing with service: see page 79
Possible causes:
- Simultaneous failure of both control processors
- Power supply failure
What should be done?
Evaluate the status of the patient and the hemodynamics
Inform 0700-berlinheart immediately.
We recommend also replacing the driving tubes each time the pump is replaced (in
univentricular mode red or blue) (see section 13.2, “Technical specifications”, p. 89 and
section 11.5.1, “Replace the driving tube”, p. 65), unless the last replacement was very
recent.
1000002 Rev. 4.9.1 75

Replace the blood pump(s)
Detecting and eliminating problems
Warning!
• Replace the pump under sterile conditions!
• When connecting the blood pump(s), pay attention to the arrows on the inflow and
outflow stubs. These show the blood flow direction.
Note
• If the backup pump has a larger volume than the blood pump to be replaced,
• it is necessary to check whether a connecting set must be used.
• The corresponding parameter must be updated in the view “Pump size and
single-step mode”.
Cautionary measure
• Sedate your patient slightly and administer a heparin bolus.
12.1.1 Prepare the replacement blood pump
Material
• 1 blood pump of appropriate type and size
• 1 driving tube (red or blue)
• 1 accessory set (for blood pumps with PU valves or tilting-disk valves)
Instructions
1. Prepare the replacement pump: Bring the membrane into the end-of-diastole position,
situate the de-airing needle, rinse and fill the pump with sterile saline solution (page 42 ff.).
2. Fit the new driving tube onto the driving tube connector of the pump.
3. Lay out the pump. The titanium connectors face upward.
12.1.2 Replacing a blood pump
Material
• 1 prepared replacement blood pump (see Section 12.1.1, p. 76)
• 1 tube attachment set from accessory set (cable tie strap, cable tie pliers)
Warning!
• If the left blood pump is replaced in biventricular mode, the right pump must also be
stopped for the duration of the replacement to prevent overloading of the pulmonary
circulation (risk of pulmonary edema).
Note
• When replacing the blood pump in univentricular mode (LVAD and RVAD), proceed as
described in point 11 and 15 under “When replacing the left pump”.
Instructions
1. Bring the patient into the Trendelenburg position.
2. Carefully cut through the cable tie strap on the inflow and outflow cannula of the faulty
pump. Immediately check the integrity of the cannulas.
3. If necessary, log on to the monitoring program: Enter the user number and password,
then confirm with .
4. In the monitoring program, select the option “Drive pause”, then confirm with .
Confirm the decision in the dialog window with or . The Ikus stops.
5. As soon as the pump has stopped, disconnect the cannulas underneath the faulty pump
and slide them off the pump.
6. Check the cannulas for deposits. If necessary, remove the deposits carefully.
7. Pull the driving tube of the faulty pump out of the connector. To do so, grab the plug by
the ribbed plug body and pull it out of the connector.
8. Close the connector on the Ikus that has become free with the seal plug.
9. Fill the free cannula ends with sterile saline solution. Ensure that they are absolutely free
of air. Connect the prepared replacement pump to the cannulas.
76 1000002 Rev. 4.9.1

Replace the blood pump(s)
10. The view “Operating mode” appears in the monitoring program. Select Univentricular or
biventricular, then confirm the desired operating mode with . In biventricular
mode, the view “Pump size and single-step mode” follows. In univentricular mode, the
connector seal test follows first, ad then the view “Pump size and single-step mode”.
11. Pull the seal plug out of the connector. When replacing the left pump: red marked connector;
when replacing the right pump: blue marked connector! Insert the plug of the new driving
tube into the connector that has become free. The plug snaps audibly into place.
12. Check that the plug is firmly seated. To do so, pull the plug above the ribbed plug body.
Never pull on the tube!
13. Loosen the tube clamps on the cannulas.
14. In the monitoring program, move the cursor to the single-step mode field.
15. When replacing the left pump: Confirm “Step left” with to trigger a single-step.
With , trigger additional individual steps until the left pump is completely deaired.
If the pump is completely de-aired: Remove the de-airing needle. In the monitoring
program, move the cursor to “Step right”, then confirm with .
16. When replacing the right pump: Confirm “Step left” with to trigger a single-step.
Move the cursor to “Step right”, then confirm with to trigger a single-step. With
, trigger additional individual steps until the right pump is completely de-aired.
If the pump is completely de-aired: Remove the de-airing needle.
17. Move the cursor to OK, then confirm with . The system restarts with the set
parameters.
18. Observe the pump filling. If necessary, adjust the parameters.
19. Secure all the connections with cable tie straps.
12.1.3 Replacing the two blood pumps
Material
• 2 prepared replacement blood pumps (see Section 12.1.1, p. 76)
• 1 tube attachment set from accessory set (cable tie strap, cable tie pliers)
Warning!
• If the left blood pump is replaced in biventricular mode, the right pump must also be
stopped for the duration of the replacement to prevent overloading of the pulmonary
circulation (risk of pulmonary edema).
Instructions
1. Bring the patient into the Trendelenburg position.
2. Carefully cut through the cable tie straps on all the inflow and outflow cannulas.
Immediately check the integrity of all the cannulas.
3. If necessary, log on to the monitoring program: Enter the user number and password,
then confirm with .
4. Select the option “Drive pause”, then confirm with . Confirm the decision in the
dialog window with or . The Ikus stops.
5. As soon as the pumps have stopped, disconnect the cannulas underneath the pumps
and slide them off the pump.
6. Check the cannulas for deposits. If necessary, remove the deposits carefully.
7. Pull the driving tubes of the pumps out of the connectors. To do so, grab the plug by the
ribbed plug body and pull it out of the connector.
8. Close the connectors on the Ikus that have become free with seal plugs.
9. Moisten the free cannula ends with sterile saline solution. Ensure that they are
absolutely free of air. Connect the prepared replacement pumps to the cannulas.
10. The view “Operating mode” appears in the monitoring program. Select biventricular,
then confirm with . The “Pump size and single-step mode” view appears.
11. Pull the seal plug out of both connectors on the Ikus.
12. Insert the plugs of the new driving tubes into the connectors. While doing so, observe the
colored markings: Insert the driving tube of the left pump into the red marked connector,
and insert the driving tube of the right pump into the blue marked connector. The plugs
snap audibly into place.
13. Check that each plug is firmly seated. To do so, pull the plug above the ribbed plug body.
1000002 Rev. 4.9.1 77

Restart the Ikus
Detecting and eliminating problems
Never pull on the tube!
14. Loosen the tube clamps on the cannulas.
15. In the monitoring program, move the cursor to the single-step mode field. Confirm
“Step left” with to trigger a single-step. With , trigger additional
individual steps until the left pump is completely de-aired.
16. Move the cursor to “Step right”, then confirm with to trigger a single-step. With
, trigger additional individual steps until the right pump is completely de-aired.
17. If both pumps are completely de-aired: Remove the de-airing needles.
18. Move the cursor to OK, then confirm with . The system restarts with the set
parameters.
19. Observe the pump filling. If necessary, adjust the parameters.
20. Secure all the connections with cable tie straps.
12.2 Restart the Ikus
Warning!
• Only switch off and restart the Ikus when requested to do so by service (e.g. in emergency
operating mode).
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN -
even when the Ikus is switched off! The only exception is battery mode: Before switching
to battery mode, move the power switch (mains power switch) to the OFF/Aus [O]
position. Immediately after restoring the power connection, move the power switch back
to the ON/Ein [I] position.
• If the curves in the monitoring program are at a standstill and the parameters cannot be
adjusted even after restarting the laptop and monitoring program, the Ikus works in
emergency pulse mode. In this case, do not proceed as described here. Proceed
according to section 12.3, “Emergency pulse mode”, p. 79.
Note
• If the Ikus is only restarted after a controlled shutdown, the Ikus runs through the start
test and all of its parameters must be set again (see page 81).
• If the Ikus is inadvertently switched off at the key switch and immediately restarted, the
Ikus resumes working with the last set parameters. If the Ikus is only restarted after more
than five minutes, the Ikus runs through the start test and all of its parameters must be
set again. If the parameters are not set again, the Ikus works with the default standard
parameters (see page 81).
Instructions
1. Supply the patient with a replacement Ikus (see Section 12.4, p. 80) or manual pump
(see Section 12.5, p. 81).
2. Seal the driving tube connectors on the Ikus with seal plugs.
3. Switch off the Ikus. To do so, in the monitoring program, select the option “Drive off”,
then confirm with . Confirm the decision in the dialog window with or .
Important: If the option “Drive off” cannot be selected, the Ikus is working in emergency
pulse mode. In this case, proceed as described in the section 12.3, “Emergency pulse
mode”, p. 79.
4. Wait until the log has been prepared. In the case of the message “Switch off drive at key
switch”, set the key switch to OFF [O].
5. Switch off the laptop.
6. Switch on the Ikus again immediately. To do so, set the key switch to ON [I].
7. Switch on the laptop. Select the option “Start program”() from the start menu. Enter
the user number and password, then confirm with .
8. Check all of the parameters and adjust them if necessary.
9. Open the red marked connector (univentricular) or both connectors (biventricular). To
do so, pull the seal plug out of the connector(s).
10. Pull the driving tube(s) off the replacement Ikus or manual pump and connect them to
the Ikus. Important: Observe the colored markings. Each plug snaps audibly into place.
11. Check that each plug is firmly seated. To do so, pull the plug above the ribbed plug body.
78 1000002 Rev. 4.9.1

Never pull on the tube!
12. Move the cursor to OK, then confirm with . The normal view appears. The
system works with the current settings.
13. Switch off the replacement Ikus (see Section 5.3.3, p. 25).
12.3 Emergency pulse mode
Emergency pulse mode
If the curves in the monitoring program are at a standstill and the parameters cannot be
adjusted even after restarting the laptop and monitoring program, the Ikus works in
emergency pulse mode. Both control processors have failed and can no longer
communicate with each other. The emergency pulse circuit board has taken over control
of the left and right pneumatic systems.
If possible, replace the Ikus with a replacement Ikus. If there is no replacement Ikus
available, the Ikus supplies your patient in emergency pulse mode until a replacement
unit can be used.
In emergency pulse mode, the Ikus works with the following settings: Synchronous
mode (biventricular), systolic pressure 200 mmHg, diastolic pressure - 40 mmHg, rate
90 bpm, relative systolic duration 40%.
Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
Warning!
• If the Ikus is working in emergency pulse mode, the complete filling and emptying of the
pump(s) must be checked immediately by visual inspection. If a pump is not filling and/
or emptying completely, the patient must be supplied immediately with the manual
pump (see section 12.5, “Operate the blood pump(s) with the manual pump”, p. 81).
• If, when emergency pulse mode begins, the backup pneumatic system was active,
the Ikus can no longer drive both pumps. In this case, the patient must be supplied
immediately with the manual pump (see section 12.5, “Operate the blood pump(s) with
the manual pump”, p. 81).
Note
• In emergency pulse mode, a controlled shutdown is not possible.
12.3.1 Emergency pulse mode - Switching off the Ikus
Warning!
• Proceed only as described here if there is no replacement Ikus available that can take
over the supply of your patient.
• The power switch (mains power switch) on the Ikus must always remain on ON/EIN -
even when the Ikus is switched off! The only exception is battery mode: Before switching
to battery mode, move the power switch (mains power switch) to the OFF/Aus [O]
position. Immediately after restoring the power connection, move the power switch back
to the ON/Ein [I] position.
Instructions
1. Supply the patient with a replacement Ikus (see Section 12.4, p. 80).
2. Seal the driving tube connectors on the Ikus with seal plugs.
3. Switch off the Ikus. In addition, set the key switch to OFF [O].
4. Switch off the laptop.
12.3.2 Ikus start test after emergency pulse mode
Warning!
• Only resume using the Ikus after Berlin Heart service has evaluated the log files or
1000002 Rev. 4.9.1 79

Connect the patient to the replacement Ikus
Detecting and eliminating problems
performed maintenance on the driving unit.
• After switching off in emergency pulse mode, always wait five minutes. Otherwise, the
Ikus may only be restarted by service.
Instructions
1. After five minutes: Switch on the Ikus. To do so, set the key switch to ON [I]. The charge
level indicator lights up and the elapsed operating hours are displayed. The mains power
indicator lights up.
2. Switch onn the laptop. The language selection menu appears.
3. Select the language by entering the corresponding number. A confirmation with
is not required. The start menu appears.
4. Select the option “Start program”() from the start menu. Enter the user number and
password, then confirm with . The system runs through the start test.
5. Wait for the test phase (a few minutes). Do not acknowledge the acoustic signal.
Messages in the message window inform you about the current status. If the system is
error-free, the “Operating mode” view appears.
6. Select “Drive off”, then confirm with .
7. Confirm the decision in the dialog window with or . The system sets the
operation immediately and writes an operating log.
8. Wait until the log has been prepared (message: “Switch off the drive at the key switch”).
Important: Do not switch on the Ikus yet.
9. Ending the monitoring program. To do so, press and confirm the decision in the
dialog window with or . The start menu appears.
10. Insert the data carrier (diskette) into the laptop. In the start menu, select the option
“Save files to diskette”. The log files are saved onto the diskette. You then return to the
start menu.
11. Remove the diskette from the laptop.
12. Switch off the Ikus. In addition, set the key switch to OFF [O].
13. Switch off the laptop.
14. Send the log files by e-mail to service@berlinheart.de.
12.4 Connect the patient to the replacement Ikus
Necessary for
• Maintenance
• Faulty Ikus
Caution!
• When switching on the Ikus, always connect it to the power supply. This is the only way
to ensure that the start test is performed completely and possible malfunctions can be
detected.
Switch on the replacement Ikus
Instructions
1. Prepare the replacement Ikus and connect it to the power supply. Secure the mains
power cable with a plug clip. Ensure that the power switch (mains power switch) is set
to ON/EIN.
2. Seal both driving tube connectors with seal plugs.
3. Switch on the replacement Ikus. To do so, set the key switch to ON [I]. The charge level
indicator lights up and the elapsed operating hours are displayed. The mains power
indicator lights up.
4. Switch onn the laptop. The language selection menu appears.
Adjust the settings of the replacement Ikus
Instructions
1. Select the language by entering the corresponding number. A confirmation with
is not required. The start menu appears.
80 1000002 Rev. 4.9.1

Systole [mmHg]
left/right
Operate the blood pump(s) with the manual pump
2. Select the option “Start program”() from the start menu. Enter the user number and
password, then confirm with . The system runs through the start test.
3. Wait for the test phase (a few minutes). Do not acknowledge the acoustic signal.
Messages in the message window inform you about the current status. If the system is
error-free, the “Operating mode” view appears.
4. Select Univentricular or biventricular, then confirm the desired operating mode with
.
5. In biventricular mode, you arrive at the view “Pump size and single-step mode”. In
univentricular mode, the connector seal test follows (duration approx. 10 seconds). The
Ikus checks that the blue marked driving tube connector is closed. Then the “Pump size
and single-step mode” view appears.
6. Transfer all parameter values from the old Ikus to the replacement Ikus.
7. Move the cursor to “Step left”, then confirm with . Biventricular: Move the cursor
to “Step right”, then confirm with .
8. Move the cursor to OK. Important: Do not confirm by clicking OK yet.
Note
• If no parameter values are entered into the replacement Ikus, the replacement Ikus starts
up with the following default parameter values (standard parameters):
Diastole [mmHg]
left/right
Default standard parameters
Rate [bpm]
• The default settings for systole, diastole and relative systolic duration depend on
whether the pump is registered as the left or right pump in the monitoring program.
• Univentricular: Default setting as for left pump.
Connecting the blood pump(s) to the replacement Ikus
Rel. systolic duration [%]
left/right
Instructions
1. Open the red marked connector (univentricular) or both connectors (biventricular). To
do so, pull the seal plug out of the connector(s).
2. If possible, log on to the monitoring program of the old Ikus. Select the option “Drive off”,
then confirm with . Confirm the decision in the dialog window with or .
The Ikus sets the operation. If the option “Drive off” cannot be selected, continue with
step 15 without switching off the Ikus.
3. As soon as the old Ikus has stopped, pull the driving tube(s) off the old Ikus. To do so,
grab the plug by the ribbed plug body and pull it out of the connector.
4. Connect the driving tube(s) to the replacement Ikus. Important: Observe the colored
markings. Each plug snaps audibly into place. Check that each plug is firmly seated. To
do so, pull the plug above the ribbed plug body. Never pull on the tube!
5. Confirm with . The replacement Ikus works with the set parameters.
6. Observe the pump filling. If necessary, adjust the parameters.
7. Switch off the first Ikus (see Section 5.3.3, p. 25).
12.5 Operate the blood pump(s) with the manual pump
Operating mode/
mode
210/ 130 -40/ -20 80 40/40 biventricular,
synchronous mode
Necessary if
• the power supply of the Ikus is not guaranteed.
• The Ikus must be restarted (e.g. in emergency operating mode) and no replacement Ikus
is available.
Cautionary measure
• Bring in one or more other people to help.
• While supplying the blood pump(s) with the manual pump, your patient should be lying
1000002 Rev. 4.9.1 81

Failure of the power supply or both control processors
Detecting and eliminating problems
down.
Instructions
1. The patient should be lying down.
2. Pull out the piston of the manual pump one half stroke length.
3. Remove the driving tube(s) from the Ikus. To do so, grab the plug by the ribbed plug
body and pull it out of the connector.
4. Connect the driving tube(s) to the manual pump. Important: Observe the colored
markings.
5. Check that each plug is firmly seated. To do so, pull the plug above the ribbed plug body.
Never pull on the tube!
6. Pump slowly and rhythmically at around 60 to 80 strokes per minute. Important: Move
the piston to its stop, because this is the only way to exert uniform and controlled
pressures.
7. Check by visual inspection whether the pump is filling and emptying completely.
b
Manual pump
Note
• During biventricular mode: Blood pumps are driven asynchronously by the manual pump.
• Seal the connector(s) of the Ikus immediately after removing the driving tube.
12.6 Failure of the power supply or both control processors
In the event of the simultaneous failure of both control processors or the failure of the
power supply, the Ikus cannot generate a specific error message in the message window.
An acoustic signal sounds and the visual signal display on the grip lights up. In the
message window, the following message appears: “Error: no data from the control
processor” or “Error: no reaction from the control processor”.
The Ikus is working in emergency pulse mode (see Section 12.3, p. 79).
Instructions
1. Check the status of the patient.
2. Check the filling and emptying of the blood pump(s).
3. If possible: provide the patient with a replacement Ikus and switch off the malfunctioning
Ikus (see Section 12.4, p. 80).
4. Always do the following immediately:
Notify hotline! +49(0)30 8187 2772
a
a Connector for blue marked driving tube
b Connector for red marked driving tube
82 1000002 Rev. 4.9.1

12.7 Read out the log files
Necessary if
• malfunctions cannot be clearly identified even after consulting with service.
Instructions
1. Exit the monitoring program with , then confirm the decision in the dialog window
with or . The start menu appears. The Ikus continues to work with the current
settings.
2. Insert the data carrier (diskette) into the laptop. In the start menu, select the option
“Save files to diskette”. The log files are saved onto the diskette. You then return to the
start menu.
3. Remove the diskette from the laptop.
4. In the start menu, select the option “Start program”() to return to the monitoring
program.
5. Enter the user number and password, then confirm with .
6. Send the log file by e-mail to service@berlinheart.de.
Warning!
• If you exit the monitoring program, you cannot identify incoming messages! Therefore,
restart the monitoring program immediately after saving the data.
• Only use diskettes for data storage. Never connect a USB stick to the laptop!
Note
• Log files are deleted from the hard drive as soon as they are transferred to a diskette.
12.8 Battery fuse
The Ikus battery unit is protected against overcurrent. In the event of overcurrent, the
battery unit is isolated by an automatic fuse. The battery fuse button on the connection
panel pops out.
Battery fuse triggered in mains power operation
Warning!
• If the battery fuse is triggered, never isolate the Ikus from the mains power. Otherwise,
the driving unit would immediately fail.
Instructions
1. Ensure that the Ikus is connected to the mains power.
2. Press the battery fuse back in to restore the power supply. Important: Only press the
button briefly. Never keep the button pressed for a longer period, because otherwise the
retriggering of the battery fuse would not be detected.
3. If the battery fuse is triggered again, do not press the button! Never keep the button
pressed down for a long period of time! If possible, supply the patient with a replacement
Ikus.
Notify hotline! +49(0)30 8187 2772
Read out the log files
1000002 Rev. 4.9.1 83

Battery fuse
Detecting and eliminating problems
Battery fuse triggered in battery mode
Warning!
• The Ikus stops immediately. The blood pumps are no longer driven.
• As long as the Ikus is in battery mode, a second person trained in the use of the manual
pump must be constantly present with the patient.
Instructions
1. Immediately supply the patient with the manual pump.
Notify hotline! +49(0)30 8187 2772
Note
• If the battery fuse is triggered in battery mode, the Ikus generates an audible alarm.
• If the power supply of the Ikus is restored within five minutes by pressing the battery fuse
button, the Ikus continues working with the last set parameters. If the Ikus is only
restarted after more than five minutes, the Ikus runs through the start test and all of its
parameters must be set again (duration approx. 10 minutes).
84 1000002 Rev. 4.9.1

13 Appendix
13.1 Overview: Product range and combination options
Overview: Product range and combination options
Note
• Custom designs can be obtained on consultation with the manufacturer.
Blood pumps with PU valves
Description Article number Inflow / outflow [mm]
Blood pump PU valve
10 ml in/out ø 6 mm
Blood pump PU valve
25 ml in/out ø 9 mm
Blood pump PU valve
30 ml in/out ø 9 mm
Blood pump PU valve
50 ml in/out ø 12 mm
Blood pump PU valve
60 ml in/out ø 12 mm
Blood pump PU valve
80 ml in/out ø 12 mm
Blood pump with tilting-disk valves
P10P-001 6/6
P25P-001 9/9
P30P-001 9/9
P50P-001 12/12
P60P-001 12/12
P80P-001 12/12
Description Article number Inflow / outflow [mm]
Blood pump tilting-disk valves
50 ml in/ out ø 12mm
Blood pump tilting-disk valves
60 ml in/ out ø 12mm
Blood pump tilting-disk valves
80 ml in/ out ø 12mm
Blood pump tilting-disk valves
80 ml out/ in ø 12mm
in/out exchanged
Blood pump tilting-disk valves
80 ml in/ out ø 16 mm
Blood pump tilting-disk valves
80 ml out/ in ø 16 mm
in/out exchanged
P50M-001 12/12
P60M-001 12/12
P80M-001 12/12
P80M-005 12/12
P80M-003 16/16
P80M-004 16/16
1000002 Rev. 4.9.1 85

Overview: Product range and combination options
Appendix
Description
Apex cannulas
Atrial cannulas
Arterial cannulas
Article
number
Head length
[mm]
Total length
[mm]
Inner diameter
[mm]
Apex cannula for newborns, staged C10A-030 10 175 5, 3; head 3
Apex cannula for infants C14A-040 14 220 5
Apex cannula for small children C18A-020 18 250 6
Apex cannula for children, staged C22A-004 28 270 12, 9; head 9
Apex cannula (Hancock-connector) C21A-001 21 200 (body length) 12
Apex cannula C27A-001 38 265 12
Apex cannula C41A-050 41 330 16
Description
Article
number
Head length
[mm]
Body length
[mm]
Inner diameter
[mm]
Atrial cannula for newborns, staged C10V-030 10 150 5, 3; head 3
Atrial cannula for infants C15V-040 15 200 5
Atrial cannula for small children C19V-020 19 250 6
Atrial cannula for children, staged
(with mandrin)
Atrial cannula for children, staged
(with mandrin)
C22V-004 22 280 9, 12; head 9
C25V-004 25 280 9, 12; head 9
Atrial cannula (with mandrin) C22V-002 22 330 12
Atrial cannula (with mandrin) C26V-002 26 330 12
Atrial cannula (with mandrin) C30V-002 30 330 12
Description
Article
number
Head angle [°]
Body length
[mm]
Inner diameter
[mm]
Arterial cannula for newborns, staged C80G-031 80 150 5, 3; head 3
Graft-adapter cannula for infants C00P-021 - 130 5
Arterial cannula for infants C80G-040 80 200 5
Arterial cannula for small children C80G-021 80 250 6
Arterial cannula for children, staged C60G-004 60 280 9, 12; head 9
Arterial cannula for children, staged C85G-004 85 280 9, 12; head 9
Graft-adapter cannula for children, staged C00P-004 - 260 9, 12; head 9
Arterial cannula C60G-002 60 330 12
Arterial cannula C85G-002 85 330 12
Arterial cannula, staged C85G-050 85 360 12, 16; head 12
Graft-adapter cannula C00P-001 - 260 12
Graft-adapter cannula C00P-050 - 260 16
86 1000002 Rev. 4.9.1

Pump: ø
connectors
[mm]
Overview: Which cannulas for which pump?
Which pump?
Cannula: ø Internal
[mm] at transition
cannula/pump
Overview: Ratio of body weight - pump size
Note
• At a body weight of above 60 kg:
• LVAD: 80 ml blood pump
• BVAD: LVAD 80 ml blood pump, RVAD 60 ml blood pump
Overview: Product range and combination options
Which inflow
cannula?
6 P10P-001 (PU) 5/ 6 C10V-030 (VH)
C15V-040 (VH)
C19V-020 (VH)
C10A-030 (AP)
C14A-040 (AP)
C18A-020 (AP)
9 P25P-001 (PU)
P30P-001 (PU)
12 P50P-001 (PU)
P60P-001 (PU)
P80P-001 (PU)
P50M-001 (KS)
P60M-001 (KS)
P80M-001 (KS)
P80M-005 (KS)
16 P80M-003 (KS)
P80M-004 (KS)
a) After cutting, the cannula is identical to C-85G-002
Explanation: • PU: PU valve
• KS: Tilting-disk valve
9 C22V-004 (VH;SZ)
C25V-004 (VH;SZ)
C22A-004 (AP;SZ)
12 C22V-004 (VH;SO)
C25V-004 (VH;SO)
C22V-002 (VH)
C26V-002 (VH)
C30V-002 (VH)
C22A-004 (AP;SO)
C21A-001 (AP)
C27A-001 (AP)
Which outflow
cannula?
(Arterial cannula)
C80G-031
C80G-040
C80G-021
C60G-004 (SZ)
C85G-004 (SZ)
C00P-004 (GA;SZ)
C60G-004 (SO)
C85G-004 (SO)
C60G-002
C85G-002
C85G-050 (SZ) a
C00P-001 (GA)
C00P-004 (GA;SO)
16 C41A-050 (AP) C85G-050 (SO)
C00P-050 (GA)
• VH: Atrial cannula
•AP: Apex cannula
• SO: Stage cannula, original diameter
• SZ: Stage cannula, diameter after cutting
• GA: Cannula with graft-adapter
1000002 Rev. 4.9.1 87

Overview: Product range and combination options
Appendix
System accessories
Description Article number
Vessel model consisting of two pressure vessels 1600171
Accessory set for blood pump with tilting-disk valves (pressure gauge, pressure gauge
set, de-airing set, de-airing hammer, tube attachment set)
Accessory set for blood pump with PU valves (membrane set, de-airing set, de-airing
hammer, tube attachment set)
Driving units
Special range
T00L-001
T00L-002
Cutting tool T00C-001
Red driving tube; length: 200 cm L20H-002
Blue driving tube; length: 200 cm L20H-003
Tensile stress relieving belt L20Z-001
Description Article number
EXCOR stationary Driving Unit Ikus (230V/50Hz) D03I-001
EXCOR stationary Driving Unit Ikus (115V/60Hz) D03I-110
EXCOR mobile driving system Excor D01E-001
Description Article number
Transmitral cannula ø12mm, length: 330 mm C90T-001
Connecting set for cannulas ø 6 mm to ø 9 mm A06-009
Connecting set for cannulas ø 9 mm to ø 12 mm A09-012
Connecting set for cannulas ø 12 mm to ø 16 mm A12-016
88 1000002 Rev. 4.9.1

13.2 Technical specifications
Product
Manufacturer and distributor
Classification
Overall system (excluding pump)
Electro-pneumatic ventricular assist Ikus EXCOR VAD with
EXCOR stationary Driving Unit Ikus
Berlin Heart GmbH
Wiesenweg 10
12247 Berlin
Germany
Class 3
Ambient operating temperature + 10 to +30 °C, with restrictions up to 35 °C
Ambient temperature in storage and
transport
Max. ambient magnetic field 10 A/m
Relative ambient air humidity 45 to 75%
Ambient atmospheric pressure 900 hPa to 1060 hPa
Pump
Dimensions see product datasheets
- 10 to +50 °C
6 h rest phase after transport before commissioning
Material Housing and membranes: polyurethane
Driving tube adapter: polyoxymethylene
Connectors: titanium
Coating of the blood contact surfaces Carmeda ® BioActive Surface (CBAS TM )
Ambient temperature of blood pump storage max. +30 °C
Duration of use recommended: 1 year; max.: 500 days
Cannulas
Dimensions see product datasheets
Material Silicone; partially textile-reinforced; partially surrounded
by suturable polyester velour; with partial flexible metal
reinforcement: wire 2 mm, steel Rd 1.4301; apex cannula
with titanium sheath; mandrin POM
Ikus
Dimensions (WxHxD) 46 x 95 x 73 cm (with the laptop closed)
46 x 120 x 73 cm (with the laptop open)
Driving tube (red/blue) Recommended lifespan: 1 year; max.: 500 days
Weight 93 kg
Input voltage AC 115 V or AC 230 V (see identification plate)
Power input 575 VA
Mains power fuse 5 A (115 V) to 3 A (230 V)
External alarm connector Electrical data: max. 24 V /1 A
Insulation data: 2.5mm/ 4 mm strike and creep distance between
alarm contact and 24V safety-low voltage inside the device
(coil side)
Insulation test voltage: 500V
Protection class IPX0 (protection against accidental contact not tested, no water
protection)
Pump frequency 30 to 150 bpm
Systolic pressure 60 to 350 mmHg
Technical specifications
1000002 Rev. 4.9.1 89

Symbols
Appendix
Diastolic pressure - 100 to 0 mmHg
Precision of pressure display ± 10%
Relative systolic duration 20 to 70%
Off-mains operating time max. 50 min (at max. 30 °C ambient temperature, otherwise less)
Battery charge duration 6 h
Maintenance interval 2000 operating hours or 6 months (at max. 30 °C ambient
temperature, otherwise 1000 operating hours or 3 months)
Max. Ikus service life 10 years
13.3 Symbols
13.3.1 Ikus: Identification plate
Symbols on the Ikus identification plate: Application component type B according to DIN EN
60601-1: 1990 + A1:1993 + A2:1995 (left); certification mark (right)
13.3.2 Ikus: connection panel
Ikus main switch (key switch) in position OFF [O] (left) and ON [I] (right)
Symbol: Connection of potential equalization according to DIN EN 60601-1: 1990 + A1:1993 + A2:1995
13.3.3 Marking of Numlock status LED
Example for marking of the Numlock status LED on the laptop
90 1000002 Rev. 4.9.1

13.4 EXCOR standard forms implantation record
EXCOR standard forms implantation record
Please fill out the implantation record form (a total of 2 pages) and fax or send a copy of it to the Berlin Heart
GmbH immediately after implantation.
After explanting the system or replacing a pump resp., please fill out the “Follow up” or the “Pump Replacement”section
resp. Fax or send a copy of the completed form to the Berlin Heart GmbH.
Berlin Heart GmbH, Wiesenweg 10, 12247 Berlin, Germany
Tel.: +49(0)30. 8187 2600, Fax: +49(0)30. 81872737, service@berlinheart.de
Hospital: City/ Country:
Patient data (for Berlin Heart registry)
Patient’s initials:
Implantation
Followup
Pump replacement
Sex m O / f O Date of birth:
Body size:
[cm]
Weight:
[kg]
Id.No.: IABP pre-op n O y O ECMO pre-op n O y O , since ___ days
On transplantation list n O y O, since _______ months
Ischemic CMP O Idiopathic CMP O Acute Myocarditis O Postcardiotomy O
Acute Myocardial Infarction O Congenital: O ____________________ Other: O ______________________
PAP mean
[mmHg]
CVP
[mmHg]
Cl
[l/min/m²] NYHA
Creatinine
[mg/dl]
Total Bilirubin
[mg/dl]
Date: Surgeon:
MAP
[mmHg]
LVEDP
[mmHg]
Platelet count
[ /μl]
LVEF %
FS %
LVEDD
[mm]
Leukocytes
[ /μl]
Type: BVAD O LVAD O RVAD O Access: medial O lateral O Left sided cannulation:atrial O apical O
LVAD Pump type: PU valve O Tilting-disk valve O
Pump size: 10 ml O 25ml O 30 ml O 50 ml O 60ml O 80ml O
RVAD Pump type: PU valve O Tilting-disk valve O
Pump size: 10 ml O 25ml O 30 ml O 50 ml O 60ml O 80ml O
Ikus no.:__________ Ikus hours of operation: ____________________________________
Date: Signature
Date: Weaning O Out of hospital O TX O Expired O
Left pump O Reason for replacement: _________________________________________
Date: Location of deposit: inflow O outflow O pump chamber O
Right pump O Reason for replacement: _________________________________________
Date: Location of deposit: inflow O outflow O pump chamber O
1000002 Rev. 4.9.1 91

EXCOR standard forms implantation record
Appendix
Please add the lot numbers of the used EXCOR ® components to this list, and fax or send a copy of it
to the Berlin Heart GmbH immediately after implantation (fax: + 49 (0)30. 8187-2737).
Hospital/City: Date of implantation:
Item
EXCOR Blood Pumps with PU valves
Lot-No.: Article number
10 ml in/out Ø 6 mm P10P-001
25 ml in/out Ø 9 mm P25P-001
30 ml in/out Ø 9 mm P30P-001
50 ml in/out Ø 12 mm P50P-001
60 ml in/out Ø 12 mm P60P-001
80 ml in/out Ø 12 mm
EXCOR Blood Pumps with Tilting-disk valves
P80P-001
50 ml in/out Ø 12 mm P50M-001
60 ml in/out Ø 12 mm P60M-001
80 ml in/out Ø 12 mm P80M-001
80 ml out/in Ø 12 mm (in/out exchanged) P80M-005
80 ml in/out Ø 16 mm P80M-003
80 ml out/in Ø 16 mm (in/out exchanged)
EXCOR Apex Cannulas
P80M-004
Ø 5/3 mm, L 17.5 cm (Apex cannula for newborns, staged) C10A-030
Ø 5 mm, L 22 cm (Apex cannula for infants) C14A-040
Ø 6 mm, L 25 cm (Apex cannula for small children) C18A-020
Ø 12/9 mm, L 27 cm (Apex cannula for children, staged) C22A-004
Ø 12 mm, L 20 cm (Apex cannula, Hancock-connector) C21A-001
Ø 12 mm, L 26,5 cm (Apex cannula, one-piece) C27A-001
Ø 16 mm, L 33 cm (Apex cannula)
EXCOR Atrial Cannulas
C41A-050
Ø 5/3 mm, L 15 cm (Atrial cannula for newborns, staged) C10V-030
Ø 5 mm, L 20 cm, head 15 mm (Atrial cannula for infants) C15V-040
Ø 6 mm, L 25 cm, head 19 mm (Atrial cannula for small children) C19V-020
Ø 12/9 mm, L 28 cm, head 22 mm (Atrial cannula for children, staged) C22V-004
Ø 12/9 mm, L 28 cm, head 25 mm (Atrial cannula for children, staged) C25V-004
Ø 12 mm, L 33 cm, head 22 mm C22V-002
Ø 12 mm, L 33 cm, head 26 mm C26V-002
Ø 12 mm, L 33 cm, head 30 mm C30V-002
Ø 12 mm, L 33 cm (Transmitral cannula, one-piece)
EXCOR Arterial Cannulas
C90T-001
Ø 5/3 mm, L 15 cm (Arterial cannula for newborns, staged) C80G-031
Ø 5 mm, L 13 cm (Graft-adapter cannula for infants) C00P-021
Ø 5 mm, L 20 cm (Arterial cannula for infants) C80G-040
Ø 6 mm, L 25 cm (Aterial cannula for small children) C80G-021
Ø 12/9 mm, L 26 cm (Graft-adapter cannula for children, staged) C00P-004
Ø 12/9 mm, L 28 cm, 85° (Aterial cannula for children, staged) C85G-004
Ø 12/9 mm, L 28 cm, 60° (Aterial cannula for children, staged) C60G-004
Ø 12 mm, L 33 cm, 60° C60G-002
Ø 12 mm, L 33 cm, 85° C85G-002
Ø 12 mm, L 26 cm (Graft-adapter cannula) C00P-001
Ø 16/12 mm, L 36 cm, 85° (Arterial cannula, staged) C85G-050
Ø 16 mm, L 26 cm (Graft-adapter cannula)
Accessories
C00P-050
Accessory set Tilting-disk valves T00L-001
Accessory set PU-valves T00L-002
Driving tube, red Ø 6/8 mm, L 2 m L20H-002
Driving tube, blue Ø 6/8 mm, L 2 m
Connecting set for Cannulas
L20H-003
Ø 6/9 mm A06-009
Ø 9/12 mm A09-012
Ø 12/16 mm A12-016
92 1000002 Rev. 4.9.1

13.5 Standard form: EXCOR pump log
13.5.1 Explanations on the pump log
7
1 11
2 10
3
5
Numbering of the checkpoints
To briefly describe the findings, we recommend the following letter codes:
p = small speck-like deposits a = small laminar deposits f = small suture t = small thrombus
P = large speck-like deposits A = large laminar deposits F = large suture T = large thrombus
~ = above the respective letter indicates floating deposits
Example: Plotting of the deposits
9
4 8
6
Example: Notation with letter code
Standard form: EXCOR pump log
1 transition inflow cannula - inflow connector
2 Only on pumps with PU valves: Inflow stub in front of inflow valve
3 inflow valve
4 inflow stub behind inflow valve
5 area between inflow and outflow stubs
6 remaining area of blood chamber
7 transition blood chamber - membrane (directly above the reinforcement ring)
8 outflow stub in front of outflow valve
9 outflow valve
10 Only on pumps with PU valves: Outflow stub behind outflow valve
11 transition outflow connector - outflow cannula
1 small laminar
3 small suture on the inflow valve
6 small specks
8 larger laminar deposits
1000002 Rev. 4.9.1 93

Standard form: EXCOR pump log
Appendix
13.5.2 EXCOR pump log
7
1
2
4
3
5
6
11 1 transition inflow cannula - inflow connector
2 Only on pumps with PU valves: Inflow stub in front of inflow valve
3 inflow valve
10
4 inflow stub behind inflow valve
9 5 area between inflow and outflow stubs
6 remaining area of blood chamber
7 transition blood chamber - membrane (directly above the reinforcement ring)
8
8 outflow stub in front of outflow valve
9 outflow valve
10 Only on pumps with PU valves: Outflow stub behind outflow valve
11 transition outflow connector - outflow cannula
Patient: Lot no. of left pump: Lot no. of right pump:
94 1000002 Rev. 4.9.1

13.6 Standard form: EXCOR parameter log
Patient: Lot no. of left pump: Lot no. of right pump:
Standard form: EXCOR parameter log
Left pump vol. Rate Drive pressure Membrane movement
Right pump vol. left right left (mmHg) right (mmHg) left right
Date Time Abbreviation bpm bpm Systole Diastole Systole Diastole Emptying Filling Emptying Filling
Example 8:00 e.g. 60 60 180 - 30 130 - 30 + + + - ++ ++
Membrane movement: Explanation of the notation
• + + : Complete or almost complete filling (max. 1 small fold in the membrane), membrane moves
to the end-of-systole or end-of-diastole position
• + - : incomplete filling or emptying movement (membrane shows more than one fold, if it is in the
end-of-systole or end-of-diastole position)
• - - : incorrect filling or emptying (membrane moves only partially or not at all)
1000002 Rev. 4.9.1 95

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

Standard form: Blood pump replacement
Appendix
13.8 Standard form: Blood pump replacement
Warning!
• Replace the pump under sterile conditions!
• When connecting the blood pump(s), pay attention to the arrows on the inflow and
outflow stubs. These show the blood flow direction.
• If the left blood pump is replaced in biventricular mode, the right pump must also be
stopped for the duration of the replacement to prevent overloading of the pulmonary
circulation (risk of pulmonary edema).
Cautionary measure
• Sedate your patient slightly and administer a heparin bolus.
Material
• 1 Blood pump of appropriate type and size
• 1 driving tube (red or blue)
• 1 accessory set (for blood pumps with PU valves or tilting-disk valves)
• 1 tube attachment set from accessory set (cable tie strap, cable tie pliers)
• or connecting set (may be necessary if the replacement pump has a larger volume than
the pump to be replaced)
What OK
Prepare the replacement pump: Bring the membrane into the end diastolic position, situate the de-airing
needle, rinse and fill the pump with sterile saline solution.
Fit the new driving tube onto the driving tube connector of the pump.
Lay out the pump. The titanium connectors face upward.
Lay out the pump. The titanium connectors face upward.
Bring the patient into the Trendelenburg position.
Carefully cut through the cable tie strap on the inflow and outflow cannula of the faulty pump.
Immediately check the cannulas for integrity.
If necessary, log on to the monitoring program: Enter the user number and password, then confirm
with .
In the monitoring program, select the option “Drive pause”, then confirm with . Confirm the
decision in the dialog window with or . The Ikus stops.
As soon as the pump has stopped, disconnect the cannulas underneath the faulty pump and slide them
off the pump.
Check the cannulas for deposits. If necessary, remove the deposits carefully.
Pull the driving tube of the faulty pump out of the connector. To do so, grab the plug by the ribbed plug
body and pull it out of the connector.
Close the connector on the Ikus that has become free with the seal plug.
Moisten the free cannula ends with sterile saline solution. Ensure that they are absolutely free of air.
Connect the prepared replacement pump to the cannulas.
The view “Operating mode” appears in the monitoring program. Select Univentricular or biventricular, then
confirm the desired operating mode with . In biventricular mode, the view “Pump size and singlestep
mode” follows. In univentricular mode, the connector seal test follows first, ad then the view “Pump
size and single-step mode”. If the backup pump is larger than the pump to be replaced: Adjust the parameter
pump size!
Pull the seal plug out of the connector. When replacing the left pump: red marked connector; when replacing
the right pump: blue marked connector! Insert the plug of the new driving tube into the connector that has
become free. The plug snaps audibly into place.
Check that the plug is firmly seated. To do so, pull the plug above the ribbed plug body. Never pull on
the tube!
Loosen the tube clamps on the cannulas.
In the monitoring program, move the cursor to the single-step mode field.
Confirm “Step left” or “Step right” with to trigger a single-step. With , trigger additional
individual steps until the pump is completely de-aired. If the pump is completely de-aired: Remove the
de-airing needle. When replacing the left pump: In the monitoring program, move the cursor to “Step
right”, then confirm with .
Move the cursor to OK, then confirm with . The system restarts with the set parameters.
Observe the pump filling. If necessary, adjust the parameters.
Secure all the connections with cable tie straps.
98 1000002 Rev. 4.9.1

13.9 Additional information: Laptop Panasonic CF29
Additional information: Laptop Panasonic CF29
Warning!
• The laptop is supplied without an internal battery and must not be upgraded under any
circumstances. The laptop is ready to use as soon as the Ikus is switched on at the main
switch. If the Ikus main switch is switched off, the laptop also cannot be operated further.
Please always adhere to the following procedure:
• Switching on: Always switch on the Ikus at the key switch first before switching on
the laptop.
• Switching off: Always shut down the laptop first before switching off the Ikus at the
key switch.
If you do not do this, data loss may occur in the .log file. The .log file is important
for service.
1000002 Rev. 4.9.1 99

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

Electromagnetic immunity - Part 1
EMC tables
14.2 Electromagnetic immunity - Part 1
Noise immunity
tests
Discharges of static
electricity (ESD)
according to
IEC 61000-4-2
Fast transient
electrical
disturbance
variables/bursts
according to
IEC 61000-4-4
Surge voltages
according to
IEC 61000-4-5
Voltage dips, shortterm
interruptions
and fluctuations of
the power supply
according to
IEC 61000-4-11
Magnetic field at the
supply frequency
(50/60 Hz)
according to
IEC 61000-4-8
The EXCOR stationary Driving Unit Ikus system is intended for operation in the electromagnetic
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.
IEC 60601 testing level Compliance level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains
power lines
± 1 kV for input and
output lines
± 1 kV alternate
mode voltage
± 2 kV synchronous
mode voltage
< 5 % UT (>95 % dip in the UT) for ½ period
40 % U T
60 % dip in the U T )
for 5 periods
70 % U T
30 % dip in the U T)
for 25 periods
< 5 % U T
(>95 % dip in the U T )
for 5 seconds
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains
power lines
± 1 kV for input and
output lines
± 1 kV alternate
mode voltage
± 2 kV synchronous
mode voltage
< 5 % UT (>95 % dip in the UT) for ½ period
40 % U T
60 % dip in the U T )
for 5 periods
70 % U T
30 % dip in the U T)
for 25 periods
< 5 % U T
(>95 % dip in the U T )
for 5 seconds
Electromagnetic environment -
guidelines
Floors should be made from wood or
concrete or be equipped with ceramic
tiles. If the floor is equipped with a
synthetic material, the relative
atmospheric humidity must be
at least 30%.
The quality of the supply voltage should
correspond to a typical commercial and
hospital environment.
The quality of the supply voltage should
correspond to a typical commercial and
hospital environment.
The quality of the supply voltage should
correspond to a typical commercial and
hospital environment. If the user of the
EXCOR stationary Driving Unit Ikus
system requires continued functionality
even when interruptions in the energy
supply occur, it is recommended to
supply the EXCOR stationary Driving
Unit Ikus system from an
uninterruptible power supply or a
battery.
3 A/m 3 A/m Magnetic fields at the mains power
frequency should correspond to
the typical values encountered in
commercial and hospital environments.
NOTE U T is the mains power AC voltage before the application of the testing level.
102 1000002 Rev. 4.9.1

14.3 Electromagnetic immunity - Part 2
Electromagnetic immunity - Part 2
The EXCOR stationary Driving Unit Ikus system is intended for operation in the electromagnetic
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.
Noise immunity tests IEC 60601 testing level Compliance level
Derived HF disturbance
variable according to
IEC 61000-4-6
Irradiated HF disturbance
variable according to
IEC 61000-4-3
3 V eff
150 kHz to 80 MHz
outside of the ISM
bands a
10 V eff
150 kHz to 80 MHz
within the ISM bands a
10 V/m
80 MHz to 2.5 GHz
[V 1]=10 V
[V 2]=10 V
[E 1 ]=10 V/m
Electromagnetic environment -
guidelines
Wearable and mobile radio devices
should not be used at a shorter distance
from the EXCOR stationary Driving Unit
Ikus system including its cables than the
recommended protection distance
calculated according to the appropriate
equation for the transmission
frequencies.
Recommended protection distance
d = 0,
35
d = 1,
2
d = 1,
2
d =
2,
3
80 MHz to 800 MHz
800 MHz to 2.5 GHz
With P as the maximum rated power
of the transmitter in watts (W)
according to the data from the
transmitter manufacturer and d as the
recommended protection distance in
meters (m). b The field strength of
stationary radio transmitters should,
at all frequencies according to an
on-site investigation, c be less than
the compliance level. d Interference is
possible in the vicinity of devices that
bear the following pictogram.
• NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
• NOTE 2 These guidelines may not be applicable to all cases. The propagation of electromagnetic variables is influenced by
absorption and reflections from the building, objects and people.
• a) The ISM frequency bands (for industrial, scientific and medical applications) between 150 kHz and 80MHz are 6,765 MHz
to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz and 40,66MHz to 40,70MHz.
• b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz to
2.5 GHz are set in order to reduce the probability of mobile/wearable communication devices causing interference if they
are inadvertently brought into the vicinity of the patient. For this reason, the additional factor of 10/3 is applied when calculating
the recommended protection distances in these frequency ranges.
• c) The field strength of stationary transmitters, e.g. base stations for cellular telephones and mobile terrestrial radio devices,
amateur radio stations, AM and FM radio and television transmitters can theoretically not be predetermined precisely.
To determine the electromagnetic environment with respect to the stationary transmitter, a study of the site should be considered.
If the measured field strength at the location exeeds the above conformance level, the normal operation for the
EXCOR stationary Driving Unit Ikus system must be monitored at each site of use to demonstrate proper function. If unusual
performance features are observed, additional corrective action may be required, e.g. a modified orientation or another
site for the EXCOR stationary Driving Unit Ikus system .
• d) Over the frequency range 150 kHz to 80 MHz, the field strength should be less than 10 V/m.
1000002 Rev. 4.9.1 103
P
P
P
P

Recommended protection distances
EMC tables
14.4 Recommended protection distances between wearable and
mobile HF telecommunications devices and the Ikus
Rated power of
the transmitter
W
The EXCOR stationary Driving Unit Ikus system is intended for operation in an electromagnetic
environment in which the HF disturbance variables are controlled. The customer
or user of the EXCOR stationary Driving Unit Ikus system can help to prevent
electromagnetic disturbances by observing the minimum distance between wearable
and mobile HF telecommunications devices (transmitters) and the EXCOR stationary
Driving Unit Ikus system - depending on the power output of the communication device
as indicated below.
Protection distance depending on the transmission frequency (m)
150 kHz to 80 MHz
outside of the ISM bands
150 kHz to 80 MHz
within the ISM bands
800 MHz to 2.5 GHz 800 MHz to 2.5 GHz
d = 0,
35 P d = 1,
2 P d = 1,
2 P d =
2,
3 P
0.01 0.04 0.12 0.12 0.23
0.1 0.11 0.38 0.38 0.73
1 0.35 1.20 1.20 2.30
10 1.11 3.79 3.79 7.27
100 3.50 12.00 12.00 23.00
For transmitters the maximum rated power of which is not indicated in the above table,
the distance can be determined using the equation in the respective column, where P is
the maximum rated power of the transmitter in watts (W) according to the information
of the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: The ISM frequency bands (for industrial, scientific and medical applications)
between 150 kHz and 80 Hz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz;
26,957 MHz to 27,283 MHz and 40,66 Hz to 40,70MHz.
NOTE 3: The compliance levels in the ISM frequency bands between 150 kHz and
80 MHz and in the frequency range of 80 MHz to 2.5 GHz are set in order to reduce the
probability of mobile/wearable communication devices causing interference if they are
inadvertently brought into the vicinity of the patient. For this reason, the additional factor
of 10/3 is applied when calculating the recommended protection distances in these frequency
ranges.
NOTE 4: These guidelines may not be applicable to all cases. The propagation of electromagnetic
variables is influenced by absorption and reflections from the building, objects
and people.
104 1000002 Rev. 4.9.1

15 About these instructions for use
The most important changes at a glance
These instructions for use provide information on the setup, functionality and use of the
EXCOR VAD with the EXCOR stationary driving unit Ikus (referred to below as Ikus). The
new Ikus (ver. 2.1 described in this manual 4.9.1) incorporates significant technical
changes from the preceding model (ver. 2.0 described in manual version 4.7.1).
• Please read all instructions for use carefully for your patients safety!
• Always ensure that only medical personnel with product-specific training are permitted
to work with the EXCOR!
15.1 The most important changes at a glance
Comparison of instructions for use versions 4.7.1 (Ikus ver. 2.0) and 4.9.1 (ver. 2.1)
Version 4.7.1 Version 4.9.1
Starting and configuring Ikus
6.1.1 Connecting the tank unit
6.1.4 Setting test parameters
6.2.1 Disconnecting the tank unit from Ikus
6.2.4 Setting the start parameters
Surgery
7Implantation 7 Implantation - Preparation in the operating room
8 Implantation - surgery
Error messages and measures
11.1 Discharging the battery pack; no battery
operation possible
11.2 Updating the parameter block failed
11.3 Acoustic alarm not correctly recognized
11.4 Alarm circuit defective - beeper stays off (or
on)
11.6 Only operate driving unit with supervision
10.3Left/right pump fills insufficiently 11.8 Please check tube and pump on left/right
10.9.2Backup processor reports error
11.12.1 Backup processor reports deviating flow
measurement on left (or right)
11.12.3 Backup processor reports error: flow
measurement on left (or right)
11.12.4 Backup processor reports incorrect testing
Appendix
13.8 Example: Blood pump replacement
13.9 Additional information: Laptop Panasonic
CF29
15.2 Explanations
Starting and configuring Ikus
The most important new information in chapter 6 (6: "Start up the Ikus and set the
parameters", S. 31) relates to use of the tank unit, which did not exist in the previous
Ikus model. Correctly configured test parameters prevent Ikus from generating false
error messages.
Surgery
The surgical procedures are described and organized differently in the two versions of
1000002 Rev. 4.9.1 105

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

Table of contents
First page................................................................................................................................................ 3
New structure of the safety information ............................................................................................... 3
Safety information.................................................................................................................................. 4
1 Important safety information................................................................................................................. 4
Warranty ................................................................................................................................................. 6
2.5 Manufacturer's warranty........................................................................................................................ 6
Start menu.............................................................................................................................................. 7
5.1 Start menu.............................................................................................................................................. 7
Unintended change of the operating mode .......................................................................................... 7
5.3.1 Pause drive: stop the Ikus temporarily.................................................................................................. 7
5.5 Switching from univentricular to biventricular operation..................................................................... 7
New transport crate ............................................................................................................................... 8
5.8 Packaging and transport ........................................................................................................................ 8
De-airing hammer ................................................................................................................................ 13
7.1.1 Preparing components and materials................................................................................................. 13
Cannula position and transcutaneous exit sites................................................................................. 13
8 Surgery.................................................................................................................................................. 13
Transcutaneous tunnel and cannula tunneling tip ............................................................................. 14
8 Surgery.................................................................................................................................................. 14
Using the connecting set ..................................................................................................................... 15
8 Surgery.................................................................................................................................................. 15
Anastomosis of inflow cannula with apex........................................................................................... 16
8.2.1 Anastomosis of inflow cannula with apex........................................................................................... 16
Securing the connections..................................................................................................................... 18
8.8 Securing the connections .................................................................................................................... 18
Tie-band gun......................................................................................................................................... 19
8.8 Securing the connections .................................................................................................................... 19
Anticoagulation therapy in young persons and adults ....................................................................... 21
9 Intensive care and post-operative care................................................................................................ 21
9.1 Postoperative anticoagulation therapy................................................................................................ 21
9.2 Postoperative platelet aggregation inhibition therapy........................................................................ 21
Replacing the driveline......................................................................................................................... 24
11.5.1 Replacing the driveline......................................................................................................................... 24
Messages.............................................................................................................................................. 24
11.8 Please check left/right pump and tube ............................................................................................... 24
11.15 The error is only detected by the active (or passive) computer ......................................................... 24
11.20 Processor failure. Contact customer service!...................................................................................... 24
11.27.3 Additional messages during the start test .......................................................................................... 25
Replacing the blood pump................................................................................................................... 25
12.1 Replacing the blood pump(s).............................................................................................................. 25
12.1.1 Replacing the blood pump because of growth of the patient ............................................................ 25
Emergency pulse mode........................................................................................................................ 26
12.3 Emergency pulse mode........................................................................................................................ 26
12.3.2 Ikus start test after emergency pulse mode ........................................................................................ 26
Reading out the log files/data storage media: USB stick ................................................................... 27
12.7 Reading out the log files ...................................................................................................................... 27
Discontinuation of the mandrin .......................................................................................................... 28
13.1 Overview: product range and combination options ........................................................................... 28
Technical specifications ....................................................................................................................... 28
13.2 Technical specifications....................................................................................................................... 28
2/28 1000095x14 Rev. 8

�
First page
Changes:
• New hotline phone number
• The text has been supplemented.
HOTLINE
DANGER
WARNING
CAUTION
NOTICE
ADVICE
Notify hotline! +49 (0)30 81 87 27 72
This document refers to the following versions
• Laptop type: CF27 to CF29 with disks; from CF30 with USB sticks
New structure of the safety information
Changes:
• Identification and classification of the safety information have been revised.
Indicates a hazardous situation which, if not avoided, will result in
death or serious injury to the patient.
Indicates a hazardous situation which, if not avoided, may result in
death or serious injury to the patient.
Indicates a hazardous situation which, if not avoided, may result in
minor or moderate injury to the patient. The device may suffer
damage.
Indicates practices which do not entail personal injury. The device may
suffer damage.
This symbol identifies measures and working techniques which have
proved useful and successful in conjunction with EXCOR and which
we therefore recommend.
IMPORTANT: the notes on safety which are identified in the instructions for use with
the signal word Danger do not necessarily fall into the above-named category of
Danger. As a rule they are notes on safety of the Warning category.
1000095x14 Rev. 8 3/28

Safety information
1 Important safety information
Changes:
• The safety information has been supplemented.
WARNING
The EXCOR system and its components may be used only by
prescription of the attending physician.
Only system components may be used with the EXCOR system. No
components other than those supplied by Berlin Heart may be used.
The warranty shall otherwise be voided.
The long-term storage conditions for all sterile products must be
observed: temperature +15°C to 25°C, relative humidity 35% to 50%.
Store in a dry place! Otherwise there is a risk that the products may no
longer be sterile.
Do not resterilize or reuse EXCOR sterile components! Otherwise
there is a risk of infection or damage to materials. EXCOR sterile components
are: blood pumps, cannulae, drivelines, accessory set (de-airing
set, tube connecting set, membrane set, pressure gauge set).
Do not resterilize or reuse EXCOR sterile components after the use-by
date. Otherwise there is a risk of infection or damage to materials. The
use-by date is printed on the labels of the inner and outer packaging.
Only remove the de-airing needle if the blood pump is running and the
parameters have been adjusted.
During implantation: ensure that the blood pumps are completely free
of air at the start. Do this by first triggering a single step, then if
necessary expelling any air bubbles using the de-airing needle. See
section 6.2.6 of the instructions for use.
Do not reintroduce de-airing needles that have been once removed.
Otherwise the membrane may be damaged. See section 6.2.5 of the
instructions for use.
Do not touch the pumps or cannulae under any circumstances with
pointed or sharp objects (e.g. surgical instruments). See chapter 8 of
the instructions for use.
4/28 1000095x14 Rev. 8

During implantation: ensure that the connection between the pump
and cannula is stable and airtight. Always secure each connection with
at least one cable tie, using a tie-band gun. See section 8.8 of the
instructions for use.
Immediately after implantation: visually inspect the cannulae and their
connections.
Post-operative care: check the blood pumps and the visible parts of
the cannulae at least 3 times a day for thrombi and deposits. Check
the cannulae at least once a day for damage. See section 9.5 of the
instructions for use.
Post-operative care: ensure that the pumps, cannulae and drivelines
are never exposed to tension, version and kinks. Otherwise there is a
risk that the patient will receive inadequate support. Use a mirror to
avoid unnecessary kinking in the cannulae when visually inspecting
the underside of the pump.
Cleaning: do not use acetone or mineral oil products in the immediate
vicinity of the blood pump and driveline. Do not use corrosive agents,
solutions containing dyes, or organic solvents for cleaning the blood
pump and drivelines, since they may alter the surface of the product.
We recommend using only water or alcohol to clean the blood pump
and driveline.
Cleaning: Do not use corrosive agents, solutions containing dyes, or
organic solvents for cleaning the cannulae and transcutaneous exit
site, since they may alter the surface of the product.
We recommend using chlorhexidine solution to clean the cannulae
and transcutaneous exit site.
Monitoring program: To save data, use only the data storage media
supplied (disks/USB sticks). Otherwise there is a risk that the data
storage medium is not recognized and data are lost.
End the monitor program only in an emergency. Since the text of a
message is displayed only in the monitor program, there is no possibility
of determining the type of the message when the monitor program
is ended. When the monitor program is shut down, the only indications
that there is an error message are an acoustic signal and the fact that
the indicator lamp on the Ikus handle lights up.
1000095x14 Rev. 8 5/28

Warranty
2.5 Manufacturer's warranty
Monitor program: plug the USB stick in the USB port or pull it out only
when the laptop is switched off. Otherwise there is a risk that the USB
stick is not recognized and data are lost.
Switching between mains power and battery mode: if the LEDs on the
charge level indicator are flashing or the message Batteries discharged
- use power supply! appears: switch to mains power immediately!
If the batteries are completely discharged (the red LED light
up), if you continue to run on batteries there is a risk of total failure of
the Ikus and damage to the batteries. It is not guaranteed that Ikus can
be started after connection to the mains power. See section 5.4 of the
instructions for use.
Changes:
• The section has been revised and supplemented.
The General Terms and Conditions of Business of Berlin Heart GmbH apply, wherein
a legal warranty of 1 year is provided for. Batteries, as wearable components, are
excluded from the legal warranty. However, Berlin Heart GmbH offers a 6-month
commercial warranty on the batteries.
The legal and commercial warranties are valid only when the device is stored and
used as directed, and when the packaging is intact. This applies in particular to all
sterile packaging as well as the aluminum-coated outer packaging of the blood pump.
Claims for legal and commercial warranty are voided if the Ikus is opened by anyone
other than the service personnel of Berlin Heart GmbH or persons authorized by the
Service Department of Berlin Heart GmbH.
The following applies regarding the intended maximum periods of use:
• EXCOR blood pumps: 1 year when used as directed
• EXCOR driveline (red/blue): 1 year when used as directed
• EXCOR cannulae: no time restriction if used as directed
6/28 1000095x14 Rev. 8

Start menu
5.1 Start menu
Changes:
• The section has been supplemented.
4. Save data The LOG files can be saved on a data storage medium
(disk/USB stick) with this option. This should be done
only after consulting the Service department.
Unintended change of the operating mode
5.3.1 Pause drive: stop the Ikus temporarily
Changes:
• The section has been supplemented.
When restarting the system from the L/R separate mode there can be an unintentional
switch to the synchronous mode, although L/R separate continues to be displayed.
The pressure curves, however, will distinctly indicate the synchronous mode.
In this case:
INSTRUCTION
1. Navigate the cursor to Synchronous mode. Do not confirm with .
2. Navigate cursor to L/R separate. Do not confirm with .
3. Navigate cursor to an arbitrary pump parameter. Confirm with .
5.5 Switching from univentricular to biventricular operation
Changes:
• The section has been supplemented.
In the change from univentricular to biventricular support, an unintentional change
into the synchronous or separate mode can occur.
In this case:
INSTRUCTION
1. Select the desired mode anew.
2. Check the parameters.
1000095x14 Rev. 8 7/28

�
New transport crate
5.8 Packaging and transport
Changes:
• The section has been supplemented.
NOTICE
INSTRUCTION
1. Place the back of the crate against a wall and/or lock the brakes to prevent the
crate from moving when it is being unloaded.
2. Open the door latches. To do so, open the safety catch and turn it
counterclockwise to release the lock on the front door.
3. Swing the front door open to the left.
4. Release and fold down the ramp while keeping hold of the black securing plate.
5. Release and remove the securing plate (which is secured to the crate by a rope),
and place it next to the crate.
6. Take out the white accessory box.
7. Release the brake on the front wheel of the Ikus (by pushing the lever
upwards).
8. Stand on the ramp and carefully pull the Ikus out by the handle.
9. Remove the stretch film and plastic bag from the Ikus. Remove the stretch film
from the laptop.
HOTLINE
Do not dispose of the transport crate!
Unloading the Ikus from the transport crate
Questions:
Notify hotline! +49 (0)30 81 87 27 72
Loading the Ikus into the transport crate
During transport, the key remains in the main switch (key switch) in the [0] position.
Ikus dimensions (W x H x D): 46 x 95 x 73 cm with laptop closed
Ikus weight: 100.6 kg (approx. 219 lb)
8/28 1000095x14 Rev. 8

INSTRUCTION
1. Place the back of the crate against a
wall and/or lock the brakes to prevent
the crate from moving when it is
being loaded.
2. Open the door latches. To do so,
open the safety catch and turn it
counterclockwise to release the lock
on the front door.
3. Swing the front door open to the left.
4. Release and fold down the ramp
while keeping hold of the black
securing plate.
5. Release and remove the securing
plate (which is secured to the crate
by a rope), and place it next to the
crate.
6. Slide the laptop tray into the front
end position and secure with stretch
film.
7. The laptop tray should no longer be
able to slide or turn.
Fig. 1 Empty transport crate
Fig. 2 Laptop secured
1000095x14 Rev. 8 9/28

8. Check that the manual pump is fixed
in its mount.
9. Place a plastic bag over the Ikus and
secure on all sides with stretch film.
10. Push the Ikus straight up the ramp
and into the crate. IMPORTANT:
push by the handle.
11. Engage the brake on the front wheel
of the Ikus (by pushing the lever
downwards).
12. Place the accessory box on the floor
in front of the Ikus.
Fig. 3 Ikus packed in a plastic bag
Fig. 4 Packed white accessory box
10/28 1000095x14 Rev. 8

13. Mount the securing plate.
14. Lift up the ramp.
15. Secure the ramp with the safety
retainer.
16. Close the front door and close the
latches.
Fig. 5 Lifting up the ramp
Fig. 6 Ramp secured
Fig. 7 Closing the latch
1000095x14 Rev. 8 11/28

17. Secure the latches with cable ties.
18. The Ikus is now ready for
transportation.
Fig. 8 Securing the latch
Fig. 9 Ikus ready for transportation
12/28 1000095x14 Rev. 8

De-airing hammer
7.1.1 Preparing components and materials
Cannula position and transcutaneous exit sites
8 Surgery
Changes:
• The de-airing hammer is no longer needed.
Changes:
• The chapter has been supplemented.
Fig. 10 Cannula position following implantation
1000095x14 Rev. 8 13/28

Fig. 11 Recommended cannula exit sites (e. g. BVAD with LV apex cannulation)
Transcutaneous tunnel and cannula tunneling tip
8 Surgery
Changes:
• The chapter has been supplemented.
Cannula tunneling tip
WARNING
1 Aorta
2 Pulmonary artery
3 Right atrium
4 Apex
5 Median line
6 Sternal line
7 Parasternal line
8 Medioclavicular line
9 Possible transcutaneous tunnel for
LV apex cannulation (depending
on the size of the patient's heart)
Use the cannula tunneling tip in every possible case. If the cannula
has to be tunneled with the aid of a tube clamp: proceed as described
below. Otherwise the cannula may be damaged.
The cannula tunneling tip is a sterile single-use product and is supplied with each
cannula in the appropriate size. Exception: cannulae with � 5 mm. Cannula tunneling
tips of both sizes are enclosed with staged cannulae.
Fig. 12 Available sizes of the cannula tunneling tip
1 16 mm
2 12 mm
3 9 mm
4 6 mm
14/28 1000095x14 Rev. 8
1
2
3
4

INSTRUCTION
The sequence of anastomosis and tunneling will change depending on the type of
cannula. See section 8.2 ff. of the instructions for use.
Fig. 13 Handling the cannula tunneling tip
Tunneling cannula with the aid of a tube clamp
WARNING
INSTRUCTION
WARNING
Use the cannula tunneling tip in every possible case. If the cannula
has to be tunneled with the aid of a tube clamp: proceed as described
here. Otherwise the cannula may be damaged.
Using the connecting set
8 Surgery
1. Firmly slide the cannula tunneling tip onto the end of the cannula.
2. Advance the dressing forceps through the subcostal incision and the cannula
tunnel into the mediastinum until the end of the cannula tunneling tip can be
gripped.
3. Use the dressing forceps to firmly grip the flat end of the cannula tunneling tip,
pull it through the cannula tunnel and the incision and position it.
4. Pull the cannula tunneling tip carefully out from the cannula. In doing so, slighly
bend the cannula tunneling tip to and fro.
1. Attach tube clamps at the distal end of the cannula.
2. Pull the cannula through the transcutaneous exit site.
3. Cut of and dispose of the clamped cannula section.
Changes:
• The chapter has been supplemented.
1 Dressing forceps
2 Cannula tunneling tip
3 Cannula
Secure each of the connections with 1 cable tie. Otherwise the
connections may loosen and the patient may lose blood as a result.
1000095x14 Rev. 8 15/28

WARNING
When using a connecting set: observe the specified minimum lengths
of the connecting tube. See Tab. 1, page 16. If necessary: shorten the
cannulae to comply with the minimum length of the connecting tube.
Article No. Change in diameter Minimum length after
cutting
A12-016 16 to 12 mm 90 mm
A09-012 12 to 9 mm 75 mm
A06-009 9 to 6 mm 60 mm
Tab. 1 Connecting set: minimum lengths of the connecting tube
Anastomosis of inflow cannula with apex
8.2.1 Anastomosis of inflow cannula with apex
Changes:
• The section has been supplemented.
Make sure that the long side of the cannula tip lies remote from the
septum and parallel to the lateral wall. See Fig. 15, page 17. Otherwise
there is a risk of myocardial suction of the septal wall.
IMPORTANT: the flow direction arrow on the cannula body is aligned
with the long side of the cannula tip (except for apex cannulae C10A-
030, C14A-040 and C18A-020).
16/28 1000095x14 Rev. 8

INSTRUCTION
1. If indicated, start fibrillation.
2. Excision at the LV apex. The ideal
site is the lateral wall of the left ventricle
near the apex. Distance
between LAD (septum) and center of
the incision: approx. 2 cm in children,
approx. 3 to 4 cm in adults.
See Fig. 15, page 17. Make a cylindrical
excision. Select the diameter
of the excision so that it is slightly
smaller than the cannula diameter.
Start the incision remote from the
septum.
3. Inspect the incision edges and the
area surrounding the incision for any
thrombi and residual trabeculae and
excise these completely.
Fig. 15 Optimum cannula position
Fig. 14 Anastomosis of inflow cannula
with LV apex
1 approx. 2 cm (children)
approx. 4 cm (adults)
2 Start of the incision remote from the septum
1000095x14 Rev. 8 17/28

Securing the connections
8.8 Securing the connections
Changes:
• The section has been supplemented.
WARNING
Secure each of the connections with 1 cable tie. Otherwise the
connections may loosen and the patient may lose blood as a result.
Visually inspect the cannulae and their connections.
INSTRUCTION
1. Pick up the tube connecting set.
2. Secure each connection between
the cannula or driveline and connector
with a cable tie. To do so, position
the cable tie precisely over the
groove profile of the connector. See
Fig. 16, page 18. IMPORTANT: position
the head of the cable tie so that
it is facing away from the patient's
body.
3. Tighten the cable tie with the tieband
gun. IMPORTANT: observe
section 8.8.
4. Optional: secure the connection with
a second cable tie. 2. Position the
second cable tie above the first one.
The heads of the cable ties must
face in opposite directions and away
from the patient's body. See Fig. 17,
page 18.
5. When using an EXCOR connecting
set: finish by securing each of the
connections with 1 cable tie, follow-
Fig. 16 Correctly positioned cable tie
ing the procedure described above.
Fig. 17 Optional: second cable tie
When using an EXCOR connecting set
INSTRUCTION
1. Finish by securing each of the connections with 1 cable tie, following the
procedure described above.
18/28 1000095x14 Rev. 8

Tie-band gun
8.8 Securing the connections
Changes:
• The section has been supplemented.
WARNING
Use only a tie-band gun which has been set correctly. Otherwise the
cannula may be damaged and the patient may lose blood as a result.
Before using the tie-band gun supplied with the EXCOR tube connecting set, its
settings must be checked and corrected if necessary.
Fig. 18 Tie-band gun
Checking the settings
INSTRUCTION
1. Coarse setting: the letters STD must
be perfectly aligned with the tip of
the arrow embossed on the gun. See
Fig. 19, page 19; 2 and 3.
2. Fine setting: the black bar in the window
must be positioned precisely at
the level of the reference line numbered
5. See Fig. 19, page 19; 1.
1 2 3
Fig. 19 Checking the settings
1000095x14 Rev. 8 19/28

If necessary: correct the settings
INSTRUCTION
1. Loosen the screw. See Fig. 20,
page 20; 2.
2. Remove the safety cap. See Fig. 20,
page 20; 1.
Fig. 20 Removing the safety cap
3. Correct the coarse setting: turn the
wheel for the coarse setting so that
the letters STD are perfectly aligned
with the tip of the embossed arrow.
See Fig. 21, page 20; 2.
4. Correct the fine setting: turn the
wheel for the fine setting so that the
black bar in the window is positioned
precisely at the level of the reference
line numbered 5. See Fig. 21,
page 20; 1.
5. Replace the safety cap and secure
1 2
with the screw. Fig. 21 Correcting setting
20/28 1000095x14 Rev. 8
1
2

Anticoagulation therapy in young persons and adults
Changes:
• The chapter has been revised and supplemented.
9 Intensive care and post-operative care
9.1 Postoperative anticoagulation therapy
Start of therapy
No anticoagulants administered during first 24 hours postoperatively.
After approx. 24 hours, start i.v. administration of unfractionated heparin (UFH),
subject to platelet count (>80,000/µl) and the results of thrombelastography.
Oral anticoagulation
INR 3.0 - 3.5 Vitamin K antagonist, p.o.
INR 2.0 - 2.5 LMWH (e. g. enoxaparin) 1.0 mg/kg/ d - prophylactic doses
INR < 2.0 LMWH 1.0 mg/kg/ 2xd - therapeutic dose or UFH i. v.
9.2 Postoperative platelet aggregation inhibition therapy
Start of therapy
• not earlier than days 2-4 postoperatively
• if platelet count >100,000/µl
Monitoring frequency
• daily - until sufficient platelet inhibition is achieved
• weekly - until discharge
• monthly - after discharge
• after each dose adjustment
Platelet adhesion inhibition
2nd postoperative day - dipyridamol 150 mg/d to 1 g/d and ADP inhibition > 50%.
Platelet aggregation inhibition
4th postoperative day, drains removed and if activation by AA > 30% - start with ASA
50 mg/d and, if necessary, titration to 325 mg/d up to AA inhibition > 70% (AA =
arachidonic acid). If drains are still in on POD 7 and activation by AA > 30%: start
with ASA as described above.
In the event of aspirin resistance or thrombogenesis in the pumps, despite sufficient
anti-aggregation, clopidogrel 75 mg/d is sometimes administered
1000095x14 Rev. 8 21/28

Guidelines for anticoagulation therapy
Medication - start if... Dosage guidelines Laboratory and target values
UFH
• > 24 h post op
• Platelet count
(>50 k/µl)
• Coagulation
status normal
(TEG)
Vitamin K antagonist
Complete oral nutrition
possible
Inhibition of platelet aggregation
Start with 5 - 7 IU/kg/h
(no bolus)
• depending on
liver function
• At INR > 5:
pause
Check aPPT every 6 h
Platelet
count
POD 1,
platelet
count
normal
as of POD
2: < 40 k/µl
as of POD
2: 50 -
100 k/µl
as of POD
2: > 100 k/µl
Target
aPTT
50 - 60 s
normal
22/28 1000095x14 Rev. 8
INR
50 -60 s 1.5 - 2.0
60 -80 s 2.0 - 2.5
• Check INR daily
• Target INR 3.0 - 3.5
• With low INR see LMWH
guidelines (see below)
Collagen serves as control and should not be suppressed. Target value epinephrine: 40 – 50%
Dipyridamole: POD 2 and
ADP > 50%
Aspirin: POD 4, if all
drains and AA > 50%
Clopidogrel: in the event
of resistance to aspirin or
thrombo-embolic
complications
Start with 150 mg/d (up
to 1 g/d)
Start with 50 mg/d
(increase as required)
ADP < 50%
AA < 30%
Start with 75 mg/d ADP < 30%
Tab. 2 Guidelines for anticoagulation therapy in young persons and adults

Medication - start if... Dosage guidelines Laboratory and target values
Fractionated heparin (LMWH)
Start at suboptimum INR
or if
• oral
administration
not possible
• INR unstable
• changing
antibiotics
Omega 3 fatty acids
EPA/ DHA 1 - 3 g/d
Dosage (e.g.
enoxaparin): every 12 h
• INR = 2.0 - 2.5:
prophylactic
dosage
(1.0 mg/kg/d)
• INR < 2.0
(or use of i.v.
UFH):
therapeutic
dosage
(1.0 mg/kg,
2x/d)
Tab. 2 Guidelines for anticoagulation therapy in young persons and adults
Target: anti-Xa level
Therapeutic level 0.6 - 1.0 U/ml divided
over 2 doses per day
• blood withdrawal 4 h after
2nd dose
• at stable level: check once
weekly
1000095x14 Rev. 8 23/28

Replacing the driveline
11.5.1 Replacing the driveline
Changes:
• The section has been supplemented.
WARNING
Check drivelines regularly by visual inspection for irregularities or
damage. Replace drivelines immediately if damaged.
The drivelines (red/blue) have a maximum period of use of 1 year. After this period,
they must be replaced.
Messages
11.8 Please check left/right pump and tube
Changes:
• The section has been supplemented.
IMPORTANT: if this message appears during biventricular operation in one pump and
the user stops the other pump, the message will be deleted during the subsequent
start test, irrespective of whether the cause of the message still exists.
11.15 The error is only detected by the active (or passive) computer
Changes:
• The section has been supplemented.
Only the active computer has detected an error. This message only appears in conjunction
with an additional, actual error message. There may be a delay of several
seconds between the two messages. It is essential to wait for the second message to
appear. Immediately take all of the measures required by the second message.
11.20 Processor failure. Contact customer service!
Changes:
• The section has been supplemented.
IMPORTANT: it is possible that this message may not be displayed depending on the
time of occurrence of the error. Ikus will then raise an alarm only visually and acoustically.
24/28 1000095x14 Rev. 8

11.27.3 Additional messages during the start test
�
Changes:
• The section has been supplemented.
• Error: 0000 0011 0011 0111 (fault in power supply)
Replacing the blood pump
12.1 Replacing the blood pump(s)
Changes:
• This section has been supplemented by a note on safety.
• This section has been supplemented by section 12.1.1 Replacing blood pump
because of growth of the patient.
WARNING
CAUTION
HOTLINE
Remove cable tie at the connector stub of the blood pump with a blunt
tool. IMPORTANT: do not use pointed or sharp-edged objects (surgical
instruments) under any circumstances. Otherwise the cannula may be
damaged.
12.1.1 Replacing the blood pump because of growth of the patient
For children, plan for a switch to a larger blood pump(s) ahead of time.
Otherwise there is a danger of inadequate support due to a discharge
rate that is too low.
It is possible that the blood pump selected at the time of implantation cannot
guarantee adequate support for the entire period of therapy. Physical growth and/or
an increase in weight of the patient can mean that the patient is not adequately
supported with the present pump. Therefore plan for a replacement of the blood
pump ahead of time. Refer to the table showing the ratio between body weight and
pump size in section 13.1 Overview: product range and combination options. This
table serves solely for orientation purposes and cannot be applied in every individual
case. The surgeon must select a pump in consultation with the Berlin Heart GmbH.
Notify hotline! +49 (0)30 81 87 27 72
When replacing the blood pump(s), proceed according to the instructions for use.
See section 12.1 of the instructions for use.
1000095x14 Rev. 8 25/28

Emergency pulse mode
Changes:
• The sections have been supplemented.
12.3 Emergency pulse mode
In the emergency pulse mode, the acoustic alarm can neither be acknowledged at
the laptop nor muted at the handle.
12.3.2 Ikus start test after emergency pulse mode
INSTRUCTION
1. Wait for 5 minutes.
2. For laptops with a USB port: insert the USB stick into the USB port.
3. Switch on the Ikus. To do so, turn the main switch (key switch) to the ON/EIN [I]
position. The battery charge indicator will light up and the elapsed operating
hours will be displayed. The mains operation indicator will be illuminated.
4. Switch on the laptop. The language selection menu will appear.
5. Select the language by entering the corresponding number. A confirmation with
is not required. The start menu will appear.
6. Select option 1. Start program () from the start menu. Enter the user
number and password, then confirm with . The system will run through
the start test.
7. Wait for the test phase to complete (a few minutes). Do not mute the acoustic
signal. Messages in the message window inform you about the current status. If
the system is found to be operating correctly, the view Select operating mode
will appear next.
8. Select Drive OFF and confirm with .
9. Confirm the decision in the dialog window with or . The system will
cease operating immediately and will write an operating log file.
10. Wait until the log is complete (message: Switch off drive with key switch).
IMPORTANT: do not switch the Ikus off yet.
11. End the monitor program. Press and confirm the decision in the dialog
window with or . The start menu will appear.
12. For laptop with disk drive: insert the disk into the laptop.
13. Select option 4. Save data () from the start menu. The log files will be saved
onto the disk or USB stick. The start menu will reappear.
14. For laptop with disk drive: remove the disk from the laptop.
15. Switch off the Ikus. To do so, set the key switch to OFF [O].
16. Switch off the laptop.
17. For laptop with USB port: take the USB stick out of the USB port (never do this
when the laptop is still switched on).
18. E-mail the log files to service@berlinheart.de.
26/28 1000095x14 Rev. 8

Reading out the log files/data storage media: USB stick
12.7 Reading out the log files
Changes:
• The section has been supplemented.
WARNING
After reading out the log files: restart the monitor program immediately.
Otherwise incoming messages cannot be identified!
To save data, use only the data storage media supplied (disks/USB
sticks). Otherwise there is a risk that the (incorrect) data storage
medium will not be recognized or that the data will not be saved.
Use the supplied data storage media exclusively for reading and
saving the log files.
Laptops of type CF30 and higher: saving log files to USB stick
INSTRUCTION
1. End the monitor program with , then confirm the decision in the dialog
window with or . The start menu will appear. The Ikus will operate with
the current settings.
2. Switch off the laptop.
3. Insert the USB stick into the USB port (never do this while the laptop is
switched on).
4. Switch on the laptop.
5. Select option 4. Save data from the start menu. The log files will be saved onto
the USB stick. The start menu will reappear.
6. Switch off the laptop.
7. Remove the USB stick from the USB port (never do this while the laptop is
switched on).
8. Switch on the laptop. To return to the monitor program select the option 1. Start
program in the start menu.
9. Enter the user number and password, then confirm with .
10. E-mail the log files to service@berlinheart.de.
1000095x14 Rev. 8 27/28

Discontinuation of the mandrin
13.1 Overview: product range and combination options
Changes:
• Due to design changes to the cannulae, the mandrins for the atrial cannulae
(C23V-004, C22V-002 and C26V-002) are no longer applicable with immediate
effect. Only the apex cannula C27A-003 (previously cannula S-111) will
continue to be delivered with mandrin).
Technical specifications
13.2 Technical specifications
Changes:
• The section has been revised and supplemented.
Ambient atmospheric pressure max. 2000 m (6562 ft) above sea level
Long-term storage conditions for sterile Temperature +15°C to +25°C
products
Relative humidity 35% to 50%
Store in a dry place!
28/28 1000095x14 Rev. 8