EXCOR VAD. with Stationary Driving Unit Ikus. Instructions for use: version Berlin Heart GmbH Wiesenweg Berlin Germany

Transcription

1 EXCOR VAD with Stationary Driving Unit Ikus for use: version Berlin Heart GmbH Wiesenweg Berlin Germany Tel.+49 (0) Fax+49 (0) Hotline +49 (0)

2

3 Hotline: 0700-berlinheart (+49(0) ) 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 The EXCOR ventricular assist device (UMDNS number: ) 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 Manufacturer Berlin Heart GmbH Wiesenweg Berlin Imprint January 2008 Berlin Heart GmbH Wiesenweg 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 Rev i

4 ii Rev

5 Table of contents 1 Important safety information Conditions of use Handling Risks and adverse effects Combination with other products/procedures General product information Use in accordance with the intended applications Indications Contraindications Possible objectives of the therapy Manufacturer s warranty Operator obligations Packaging and sterility Transportation and storage Maintenance Disposal Description: Blood pump, cannulas, accessories EXCOR blood pumps EXCOR cannulas EXCOR accessories Description: Stationary Driving Unit Ikus Overview Displays and operating elements Connection panel Display and operating panel Power supply Operating modes Univentricular mode Biventricular mode Laptop with monitoring program Safety Fall-back redundancy of pneumatic systems for univentricular mode Fall-back redundancy of pneumatic systems for biventricular mode Control processor design with fall-back redundancy Rev iii

6 4.6.4 Battery mode Manual pump Password-protected user profiles (entry code) for use: Ikus Start menu Select options from the start menu Add/ change/ delete entry code Save data to floppy Change date/time Fundamentals of the monitoring program Starting the monitoring program Ending the monitoring program Logging on and off from the monitoring program Normal view of monitoring program Select options in the monitoring program Adjust the parameter values Scroll through the message window Stop the blood pumps, switch off the Ikus Drive pause: Stop the Ikus temporarily Pause left/pause right: Stop individual blood pumps (and switch them off if necessary) Drive off: Switch off the Ikus Switching between mains power and battery mode Switching from univentricular to biventricular mode Routine start test in the event of non-use Moving the Ikus Packaging and transport Start up the Ikus and set the parameters Preparations outside of the operating room Connecting the vessel model Switch on the Ikus Starting the monitoring program Setting the test parameters Intraoperative drive management Disconnect the vessel model from the Ikus Select the operating mode ( Operating mode view) Selecting the pump size Setting the startup parameters...35 iv Rev

7 6.2.5 Connect the blood pump(s) to the Ikus De-air the pump(s) in single-step mode Start the pump (switch to normal view) Check and adjust the parameters when the pump is started Switching from HLM to VAD Possible complications Postoperative drive management After transfer to the ward After further progress Implantation: Preparation in the operating room Preparing the components and materials Unpacking the sterile components Atrial cannulas with mandrin: Prepare the cannula Pump with PU valve Pump with tilting-disk valve De-air the pump Implantation Surgical procedure Access Apex cannula(s) Anastomosing the apex cannula Create the transcutaneous passage for the apex cannula Atrial cannula(s) Creating a transcutaneous passage for atrial cannula(s) Anastomize the inflow cannula(s) with an atrium Outflow cannula(s) Creating transcutaneous passages for outflow cannula(s) Anastomosing the outflow cannula(s) If necessary: Shorten the cannulas Connect the pumps to the cannulas Remove the de-airing needle Secure the connections Anesthesia Intraoperative anticoagulation therapy After the operation Intensive care and aftercare Postoperative anticoagulation therapy Rev v

8 9.1.1 Example: Anticoagulation therapy - Adolescents/adults Example: Anticoagulation therapy - EXCOR Pediatric Monitoring the blood values Postoperative platelet aggregation inhibition therapy Example: Platelet aggregation inhibition therapy - Adolescents/adults Example: Platelet aggregation inhibition therapy - EXCOR Pediatric Antibiotic therapy Wound care Regular inspection of blood pump(s) and cannulas Visual inspection: Filling/ ejecting of the blood pump Visual inspection: Deposits Inspection via the monitoring program Explantation Bridge-to-Transplant (BTT) Weaning (Bridge-to-Recovery, BTR) Explantation with univentricular support Explantation with biventricular assistance/support Error messages and corrective action Batteries discharged; battery mode not possible Updating the parameter block failed The acoustic alarm is not correctly detected Alarm circuit fault horn remains off (or on) Connect the driving tube Replace the driving tube Do not operate the driving unit without supervision! Backup operation left/right Please check the tube and the left/right pump Fault: <<16-digit binary code>> (<<Error type>>) Throttle valve error in system 1 (or system 2 or 3), please wait Pressure error/ time error in system 1 (or system 2 or 3) Backup processor flow measurement deviation on the left (or right) is reporting abnormal measurements on the left (or right) is reporting the error: Flow measurement on the left (or right) is reporting a checking error FATAL: Battery failure! Inform Service urgently! Error: no data/no reaction from the control processor...69 vi Rev

9 11.15 The error is only detected by the active (or passive) controller Left/right flow sensor defective. Contact Service department! No internal communication Emergency operating mode Univentricular Biventricular Problem: <<Text:>> Processor failure. Contact service! The self-test is not ended by the passive processor System 1 (or 2) is faulty System 3 is faulty System has reached maximum capacity Temperature sensors: <<8-digit binary code>> Faulty connection to the laptop Error messages during the start test Battery mode test skipped due to battery problem Faulty connection to the laptop Additional messages during the start test Detecting and eliminating problems Replace the blood pump(s) Prepare the replacement blood pump Replacing a blood pump Replacing the two blood pumps Restart the Ikus Emergency pulse mode Emergency pulse mode - Switching off the Ikus Ikus start test after emergency pulse mode Connect the patient to the replacement Ikus Operate the blood pump(s) with the manual pump Failure of the power supply or both control processors Read out the log files Battery fuse Appendix Overview: Product range and combination options Technical specifications Symbols Ikus: Identification plate Rev vii

10 Ikus: connection panel Marking of Numlock status LED EXCOR standard forms implantation record Standard form: EXCOR pump log Explanations on the pump log EXCOR pump log Standard form: EXCOR parameter log Standard form: EXCOR emergency log Standard form: Blood pump replacement Additional information: Laptop Panasonic CF EMC tables Electromagnetic immunity - Part Electromagnetic immunity - Part Recommended protection distances between wearable and mobile HF telecommunications devices and the Ikus About these instructions for use The most important changes at a glance Explanations viii Rev

11 INDEX 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 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 Rev ix

12 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: <<16-digit binary code>> (<<Error type>>) 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 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 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 x Rev 4.9.1

13 INDEX 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 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 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 Rev xi

14 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 Rev 4.9.1

15 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. 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) 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) to contact Berlin Heart GmbH. Here you can find answers to your questions relating to EXCOR Rev

16 Rev

17 Conditions of use 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 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 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 Rev

18 Risks and adverse effects 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 Important safety information 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 Rev

19 Use in accordance with the intended applications 2 General product information 2.1 Use in accordance with the intended applications 2.2 Indications 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 Rev

20 Operator obligations 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. General product information 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 (CBAS TM ) 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 Rev

21 Maintenance 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 Rev

22 Disposal General product information Rev

23 EXCOR blood pumps 3 Description: Blood pump, cannulas, accessories 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 Unit Ikus 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 a c b a Air chamber b Driving tube connector g e c Triple-layer membrane d Blood chamber (de-airing nipple on the back) h d e Arrow: points in the blood flow direction f Inflow stub i f g Outflow stub h Titanium connector: Outflow stub - Outflow cannula i Titanium connector: Inflow stub - Inflow cannula Blood pump 60 ml, here with PU valves Rev

24 EXCOR cannulas 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). Description: Blood pump, cannulas, accessories The blood contact surface of the pump is coated with Carmeda BioActive Surface (CBAS TM ). 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 Cannula heads: 1) Atrial cannula, 2) apex cannula, 3) arterial cannula Rev

25 EXCOR accessories 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) Rev

26 EXCOR accessories Description: Blood pump, cannulas, accessories Rev

27 Overview 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 Laptop with monitoring program Grip Connection panel Lifting bars Driving tubes Power cord Stationary Driving Unit Ikus 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 Rev

28 Displays and operating elements 4.2 Displays and operating elements Connection panel 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 4 Description: Stationary Driving Unit Ikus Connection panel 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 Rev

29 Power supply Display and operating panel 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) 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! Power supply 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 Rev

30 Operating modes 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 Univentricular mode LVAD RVAD In univentricular mode, the driving tube is connected to the blood pump always (even RVAD) via the red marked connector Biventricular mode Description: Stationary Driving Unit Ikus 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: " for use: Ikus", p. 19. Note If the laptop is switched off in running operation, the Ikus continues working with the currently set parameters ) Laptop, 2) Surface monitoring program Rev

31 Safety 4.6 Safety 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 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, mmhg diastolic pressure, 70 beats per minute and a relative systolic duration of 40%. Redundancy of the pneumatic systems in biventricular mode 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% Battery mode 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 Rev

32 Safety 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. Description: Stationary Driving Unit Ikus Rev

33 Start menu 5 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 <Numlock> 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 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 Select options from the start menu 1. Enter the option number (e.g. <1> 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 <2>, 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 Rev

34 Start menu Add/ change/ delete entry code 1. When the monitoring program is running: exit the monitoring program with <F10>. 2. In the start menu, select Add/ change/ delete entry code (<2>). 3. Enter the default user profile, then confirm with <Enter>. 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 <Enter>. 5. Enter the password, then confirm with <Enter>. 6. Repeat the entry, then confirm with <Enter>. 7. If necessary, repeat steps 3 to 5 to set additional user profiles. 8. Confirm all the settings together with <0>. 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 (<1>) to return to the monitoring program. 10. Enter the user number and password, then confirm with <Enter>. 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 ESC ENTF Action Reject entries not yet confirmed with <0>, end the entry code program Delete the selected users (confirmation with <Enter>) 5 Bring up help Additional options in the entry code program for use: Ikus Save data to floppy 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 Change date/time 1. When the monitoring program is running: Exit the monitoring program with <F10>. 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 <Enter>. Additional options in the program Change date/time Key <F6> <F10> ESC Action Toggle between the date or time entry fields Save and end Abort and return to the start menu Rev

35 Fundamentals of the monitoring program 5.2 Fundamentals of the monitoring program Starting the monitoring program 1. You are now at the start menu. Select the option Start program (<1>). 2. Enter the user number and password, then confirm with <Enter> Ending 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! 1. Press <F10> and confirm the decision in the dialog window with <X> or <1>. 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 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 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 <Enter>. The monitoring program shows the field Log off. You are logged on to the monitoring program. Log off 1. Select Log off, then confirm with <Enter>. The monitoring program shows the field User ID. You are logged off the monitoring program. Further entries are only possible after logging on again Rev

36 Fundamentals of the monitoring program Cautionary measure For the safety of your patient, log off the monitoring program before you leave the system Normal view of monitoring program A B C 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). for use: Ikus 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 Rev

37 Fundamentals of the monitoring program Select options in the monitoring program 1. Move the cursor with / to the desired field. A popup menu appears. 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 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 <Enter>. 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 Adjust the parameter values 1. Move the cursor with / to the desired field in the parameter table. The active field is colored underneath. 2. Adjust the value with, / <Bild >/ <Bild >, then confirm with <Enter>. 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! Rev

38 Stop the blood pumps, switch off the Ikus Note If the adjusted parameter value is not confirmed with <Enter>, then the parameter table shows the changed value, but the Ikus continues working with the original value. With <Esc>, you can discard the changed parameter display. The original value reappears in the parameter table. With <Enter>, you can confirm the change; the adjusted value is displayed in the parameter table. Parameter table Parameter possible range, changed to, changed to Systolic pressure [mmhg] 60 to Diastolic pressure [mmhg] 0 to Rate [bpm] 30 to Relative systolic duration [%] 20 to Adjust the parameters Scroll through the message window 1. Press the key <7> to move the cursor in the message window. 2. Scroll through the messages: Move one element further with,. Move four elements further with <Bild >/ <Bild >. 3. Exit the message window with <Esc> or <Enter>. The field Log off is automatically activated and underlined in black. for use: Ikus 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 Rev

39 Stop the blood pumps, switch off the Ikus Drive pause: Stop the Ikus temporarily 1. Select Drive pause, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. The Driving Unit Ikus stops. The Operating mode view appears. 2. Select Univentricular or biventricular, then confirm the desired operating mode with <Enter>. 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 <Enter>, 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.) Pause left/pause right: Stop individual blood pumps (and switch them off if necessary) 1. Select Pause left or Pause right, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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) Drive off: Switch off the Ikus Switch off the Ikus 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 <Enter>. 3. Confirm the decision in the dialog window with <X> or <1>. 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 <F10>, then confirm the decision in the dialog window with <X> or <1>. 5. In the start menu, select End (<3>), 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) Rev

40 Switching between mains power and battery mode 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 for use: Ikus 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 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.) Rev

41 Switching from univentricular to biventricular mode 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 always, except while the batteries are being charged 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 Battery status indicator flashing Message: Batteries discharged - use power supply! Remaining operating time < 10 min Remaining operating time < 2 min Remaining operating time 0 min 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! Behavior of the Ikus at different charge levels - Ikus with 8 LEDs What? When? Meaning The charge level indicator shows the charge level of the batteries always, except while the batteries are being charged 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! Displays and messages in battery mode Switch to mains power operation 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 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 <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 Rev

42 Routine start test in the event of non-use 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 <Enter>. 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. 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 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 Observe and evaluate the curve representation. 5. Select the option Drive off, then confirm with <Enter>. 6. Confirm the decision in the dialog window with <X> or <1>. 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 for use: Ikus 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) Rev

43 Moving the Ikus 5.7 Moving the Ikus Grip: Sliding the Ikus Lifting bars: Lifting 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 Rev

44 Packaging and transport Packing the Ikus 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 ) 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 for use: Ikus Rev

45 Preparations outside of the operating room 6 Start up the Ikus and set the parameters 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 <Numlock> 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 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) Connection panel Rev

46 Preparations outside of the operating room 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. Start up the Ikus and set the parameters 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! Switch on the Ikus 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 <Enter> 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 Starting the monitoring program 1. Select the option Start program (<1>) from the start menu. 2. Enter the user number and password, then confirm with <Enter>. 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 Rev

47 Intraoperative drive management Setting the test parameters 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. Systole [mmhg] left/right Diastole [mmhg] left/ right Rate [bpm] Rel. systolic duration [%] left/right Operating mode/ mode biventricular, synchronous mode Test parameters 1. Also with planned univentricular mode: Navigate the cursor to biventricular, confirm with <Enter>. 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 <Bild >/ <Bild >, then confirm with <Enter>. 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: 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 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. Notify hotline! +49(0) Intraoperative drive management Disconnect the vessel model from the Ikus 1. Disconnect both pressure vessels from the Ikus. 2. Seal the driving tube connection sockets with seal plugs Rev

48 Intraoperative drive management Select the operating mode ( Operating mode view) Operating mode view 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 <Enter>. 3. During biventricular mode: You arrive at the view Pump size and single-step mode (Section on p. 34). During univentricular mode, the connector seal test follows: The Ikus checks that the blue marked driving tube connector is closed. Start up the Ikus and set the parameters Univentricular mode: Connector seal test 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 <Enter>. 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 Selecting the pump size 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 Rev

49 Intraoperative drive management Setting the startup parameters 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. 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 <Bild >/ <Bild >, then confirm with <Enter>. 2. Setting the startup parameters: Systole [mmhg] left/right Diastole [mmhg] left/right Rate [bpm] Rel. systolic duration [%] left/right 100/ 80-5/ /40 Startup parameters Connect the blood pump(s) to the Ikus 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). 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 biventricular univentricular Connector on the Ikus LVAD: red marked connector RVAD: blue marked connector LVAD or RVAD: red marked connector Allocation: Operating mode, blood pump, connector Rev

50 Intraoperative drive management Caution! Do not bend the driving tubes! 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. Start up the Ikus and set the parameters 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 <Enter> 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 <Enter>, 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) 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). 1. Move the cursor to OK, then confirm with <Enter>. The system now starts with the parameter values visible in the parameter table 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. 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 Rev

51 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: 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? Corrective action 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! 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 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 <Bild >/ <Bild >, then confirm with <Enter>. Parameter possible range, changed to <Bild >/ <Bild > changed to Systolic pressure [mmhg]; driving pressure Diastolic pressure [mmhg]; suction pressure 60 to to Rate [bpm] 30 to Relative systolic duration [%] 20 to Parameter: possible ranges 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 Rev

52 Intraoperative drive management remains identical. separate pulse is sometimes helpful in patients with intracardial shunts. 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 <Enter>. The system works in the set operating mode. Target values 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. Start up the Ikus and set the parameters Systole [mmhg] left/right 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 Switching from HLM to VAD Rate [bpm] 220/150-40/ /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). 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) Rev

53 Intraoperative drive management Possible complications 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. 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. 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 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 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.) Rev

54 Postoperative drive management 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 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 Start up the Ikus and set the parameters 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 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) Rev

55 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. 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 Rev

56 Pump with PU valve 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. Implantation: Preparation in the operating room 7.4 Pump with PU valve b a De-airing nipple and driving tube connector Move the membrane into the end-of-diastole position 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 e a De-airing nipple (blood chamber) b Driving tube connector (air chamber) 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 Rev

57 De-air the pump 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 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. What should be done? 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. 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) c b 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 d Pump with inserted trocar (de-airing needle with inserted obturator) Situate the de-airing needle e Caution! The membrane must now be located in the end-of-diastole position. The membrane set or pressure gauge set is now connected Rev

58 De-air the pump Implantation: Preparation in the operating room 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 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 Rev

59 Access 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 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) 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 Rev

60 Apex cannula(s) a a Long side of the cannula head Head of an apex cannula 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 Implantation Surgical procedure Circularly applied sutures at the apical incision On a cannula with an additional suture ring (apex cannula C41A-050, inner diameter 16 mm) 1. Induce ventricular fibrillation if necessary. 2. Apply 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 Create the transcutaneous passage for the apex cannula 1. Apply 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 Rev

61 Atrial cannula(s) 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 Creating a transcutaneous passage for atrial cannula(s) 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 Anastomize the inflow cannula(s) with an atrium Right atrium a) Closed technology Anastomosing the atrial cannula(e) 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 Rev

62 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. 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! Implantation Surgical procedure 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) 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 Creating transcutaneous passages for outflow cannula(s) 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 Rev

63 If necessary: Shorten the cannulas Anastomosing the outflow cannula(s) Aorta 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. Anastomosis of the aortal cannula Pulmonary artery 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. Cannulation of the pulmonary artery 8.5 If necessary: Shorten the cannulas 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) Rev

64 Connect the pumps to the cannulas 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 Apex Apex points upward... Blood chamber Air chamber RVAD Atrium Air chamber LVAD Atrium Air chamber Implantation Surgical procedure 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. 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 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 Rev

65 Remove the de-airing needle are adjusted gradually (see page 36). 8.7 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. 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: 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 Rev

66 After the operation 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 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 After the operation Implantation Surgical procedure 1. Fill out the implantation log and fax it to Berlin Heart GmbH. For an example, see page Rev

67 Postoperative anticoagulation therapy 9 Intensive care and aftercare 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 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 Example: Anticoagulation therapy - Adolescents/adults Start of therapy In the first h postoperatively, no administration of anticoagulants. After approx h, start of heparin administration (i.v.) depending on the thrombocyte count (>80,000/μl) and bleeding (<50ml/h) and the result of the thromboelastography. PTT PTT should be performed every 6 h. At a thrombocyte count of <100,000/μl, the target PTT is 50-60s 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 <50s or >80s necessary: If the thrombocyte function is substantially disturbed (e.g. due to hemofiltration): Target PTT <50s If very good thrombocyte function exists at a thrombocyte count of >300,000/μl: Target PTT >80s If fibrinogen >300g/l: Target PTT s Rev

68 Postoperative anticoagulation therapy 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 INR 2.2 to 2.9 INR <2.2 Vitamin K antagonist, p.o. 0.3 ml/kg 2x/d low molecular weight heparin, s.c. Heparin, i.v. Note The accuracy of the INR measurement of a laboratory varies by 0.2; between different laboratories, it varies by up to +/ Example: Anticoagulation therapy - EXCOR Pediatric Start of therapy In the first h postoperatively, no administration of anticoagulants. After approx h, start of heparin administration (i.v.) depending on the thrombocyte count (>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. Intensive care and aftercare PTT PTT should be performed every 6 h. At a thrombocyte count of <100,000/μl, the target PTT is 50-60s 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 <50s or >80s necessary: If the thrombocyte function is substantially disturbed (e.g. due to hemofiltration): Target PTT <50s If very good thrombocyte function exists at a thrombocyte count of >300,000/μl: Target PTT >80s If fibrinogen >300g/l: target PTT s 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 INR 2.0 to 2.7 INR <2.0 Vitamin K antagonist, p.o. Age-specific dose, s.c. Heparin, i.v Rev

69 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 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 Rev

70 Antibiotic therapy 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) 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 Intensive care and aftercare 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) Rev

71 Wound care 4 sterile-packaged gauze compresses (each approx. 10x20 cm) 4 Metalline drain compresses (approx. 6x7 cm) or corresponding product Removing the old dressing material 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 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 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 Rev

72 Regular inspection of blood pump(s) and cannulas 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 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. Intensive care and aftercare 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 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 Rev

73 Regular inspection of blood pump(s) and cannulas Visual inspection: Filling/ ejecting of the blood pump 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). 1. Move the cursor with / to the desired field in the parameter table. The active field is colored underneath. 2. Adjust the value with, / <Bild >/ <Bild >, then confirm with <Enter>. The system works with the new value. Cautionary measure Confirm each changed parameter value individually with <Enter>. The system only applies the changed values after this confirmation 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! Rev

74 Regular inspection of blood pump(s) and cannulas Inspection of the pump areas with blood contact transition inflow cannula - inflow connector 2 Only on pumps with PU valves: Inflow stub in front of inflow valve inflow valve 4 inflow stub behind inflow valve 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! 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. Intensive care and aftercare Recommendation Log the parameter values once per day. To log the parameters, use the standard form EXCOR parameters (standard form see page 95) Rev

75 Bridge-to-Transplant (BTT) 10 Explantation 10.1 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 1. Supply the patient via the HLM. 2. In the monitoring program, select the option Drive off, then confirm with <Enter>. 3. Confirm the decision in the dialog window with <X> or <1>. 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 <F10>, then confirm the decision in the dialog window with <X> or <1>. 7. In the start menu, select End (<3>), 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 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 Rev

76 Weaning (Bridge-to-Recovery, BTR) 10.2 Weaning (Bridge-to-Recovery, BTR) Explantation with univentricular support Procedure identical to BTT. Stitch over the insertion sites of all cannulas Explantation with biventricular assistance/support Stop the right pump 1. Select the option Pause right, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 <Enter>. The Ikus continues to work. You arrive at the normal view. Switch off the Ikus 1. Supply the patient via the HLM. 2. In the monitoring program, select the option Drive off, then confirm with <Enter>. 3. Confirm the decision in the dialog window with <X> or <1>. 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 <F10>, then confirm the decision in the dialog window with <X> or <1>. 7. In the start menu, select End (<3>), 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. Explantation Rev

77 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) ). 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 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 <Enter>. 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 Rev

78 Batteries discharged; battery mode not possible 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! 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) Error messages and corrective action 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) 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 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. 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) Rev

79 Alarm circuit fault horn remains off (or on) 11.4 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) Connect the driving tube 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 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) 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 <Enter>. 3. Select the option Drive pause, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 Rev

80 Do not operate the driving unit without supervision! 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 <Enter>. 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 <Enter>. 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 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! Error messages and corrective action 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) 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). 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 , 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.) Fault: <<16-digit binary code>> (<<Error type>>) Notify hotline! +49(0) 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 Rev

81 Throttle valve error in system 1 (or system 2 or 3), please wait 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) 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) 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 , 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! Backup processor 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) 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: 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 Rev

82 FATAL: Battery failure! Inform Service urgently! 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) 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. 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, / <Bild >/ <Bild >, then confirm with <Enter>. The system works with the new value. If the message appears again: Notify hotline! +49(0) Error messages and corrective action 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! 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) 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! 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) Rev

83 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. 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) 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) 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! 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) Note If the defective Ikus is not replaced, this message appears cyclically at 10-minute intervals Rev

84 No internal communication 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. 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) Emergency operating mode 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. Error messages and corrective action 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) 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) Rev

85 Problem: <<Text:>> Problem: <<Text:>> 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. 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) Processor failure. Contact service! One of the processors has failed. Immediately do the following: Notify hotline! +49(0) 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. 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) 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) In backup operation The Ikus is working in emergency operating mode Rev

86 System 3 is faulty Notify hotline! +49(0) 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) In backup operation The Ikus is working in emergency operating mode. Notify hotline! +49(0) Error messages and corrective action 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 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) 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 Rev

87 Temperature sensors: <<8-digit binary code>> Temperature sensors: <<8-digit binary code>> 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! 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 ). 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) 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 Error messages during the start test Battery mode test skipped due to battery problem The charge level of the batteries is too low to permit battery mode. 1. Operate the Ikus on mains power. Battery mode is only possible if all of the yellow LEDs are illuminated 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 Rev

88 Error messages during the start test 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 Error messages and corrective action 1. According to the display: If necessary: enter <7> to read message; go back by pressing <Enter>. Essential: enter <1> or <x> to exit the monitoring program. A second window appears. 2. Second window: According to the display, select the option <Continue>. 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) Rev

89 Replace the blood pump(s) 12 Detecting and eliminating problems Possible problems Problem Visible defects on the Ikus Cause / Corrective action Inform 0700-berlinheart Visible defects on the pump Replace the pump: see page 75 Deposits in the pump 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 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 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. For all questions / uncertainties: Notify hotline! +49(0) 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 Replace the blood pump(s) Necessary if a visible defect exists in the pump(s) floating deposits are found in the pump(s) Recommendation 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 , Replace the driving tube, p. 65), unless the last replacement was very recent Rev

90 Replace the blood pump(s) 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 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) Detecting and eliminating problems 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 Replacing a blood pump Material 1 prepared replacement blood pump (see Section , 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. 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 <Enter>. 4. In the monitoring program, select the option Drive pause, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 Rev

91 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 <Enter>. 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 <Enter> to trigger a single-step. With <Enter>, 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 <Enter>. 16. When replacing the right pump: Confirm Step left with <Enter> to trigger a single-step. Move the cursor to Step right, then confirm with <Enter> to trigger a single-step. With <Enter>, 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 <Enter>. 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 Replacing the two blood pumps Material 2 prepared replacement blood pumps (see Section , 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). 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 <Enter>. 4. Select the option Drive pause, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 <Enter>. 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 Rev

92 Restart the Ikus 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 <Enter> to trigger a single-step. With <Enter>, trigger additional individual steps until the left pump is completely de-aired. 16. Move the cursor to Step right, then confirm with <Enter> to trigger a single-step. With <Enter>, 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 <Enter>. 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 Restart the Ikus Detecting and eliminating problems 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). 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 <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 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 (<1>) from the start menu. Enter the user number and password, then confirm with <Enter>. 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 Rev

93 Emergency pulse mode Never pull on the tube! 12. Move the cursor to OK, then confirm with <Enter>. The normal view appears. The system works with the current settings. 13. Switch off the replacement Ikus (see Section 5.3.3, p. 25) 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) 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 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. 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 Ikus start test after emergency pulse mode Warning! Only resume using the Ikus after Berlin Heart service has evaluated the log files or Rev

94 Connect the patient to the replacement Ikus 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. Detecting and eliminating problems 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 <Enter> is not required. The start menu appears. 4. Select the option Start program (<1>) from the start menu. Enter the user number and password, then confirm with <Enter>. 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 <Enter>. 7. Confirm the decision in the dialog window with <X> or <1>. 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 <F10> and confirm the decision in the dialog window with <X> or <1>. 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 to service@berlinheart.de 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 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 1. Select the language by entering the corresponding number. A confirmation with <Enter> is not required. The start menu appears Rev

95 Operate the blood pump(s) with the manual pump 2. Select the option Start program (<1>) from the start menu. Enter the user number and password, then confirm with <Enter>. 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 <Enter>. 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 <Enter>. Biventricular: Move the cursor to Step right, then confirm with <Enter>. 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): Systole [mmhg] left/right Diastole [mmhg] left/right Rate [bpm] Rel. systolic duration [%] left/right Operating mode/ mode 210/ / /40 biventricular, synchronous mode Default standard parameters 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 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 <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 <Enter>. 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) Operate the blood pump(s) with the manual pump 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 Rev

96 Failure of the power supply or both control processors down. 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. a Connector for blue marked driving tube b Connector for red marked driving tube a Detecting and eliminating problems 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 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). 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) Rev

97 Read out the log files 12.7 Read out the log files Necessary if malfunctions cannot be clearly identified even after consulting with service. 1. Exit the monitoring program with <F10>, then confirm the decision in the dialog window with <X> or <1>. 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 (<1>) to return to the monitoring program. 5. Enter the user number and password, then confirm with <Enter>. 6. Send the log file by to 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 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. 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) Rev

98 Battery fuse 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. 1. Immediately supply the patient with the manual pump. Notify hotline! +49(0) 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). Detecting and eliminating problems Rev

99 Overview: Product range and combination options 13 Appendix 13.1 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 P10P-001 6/6 P25P-001 9/9 P30P-001 9/9 P50P /12 P60P /12 P80P /12 Blood pump with tilting-disk valves 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 /12 P60M /12 P80M /12 P80M /12 P80M /16 P80M / Rev

100 Overview: Product range and combination options Apex cannulas Description Article number Head length [mm] Total length [mm] Inner diameter [mm] Apex cannula for newborns, staged C10A , 3; head 3 Apex cannula for infants C14A Apex cannula for small children C18A Apex cannula for children, staged C22A , 9; head 9 Apex cannula (Hancock-connector) C21A (body length) 12 Apex cannula C27A Apex cannula C41A Atrial cannulas Description Article number Head length [mm] Body length [mm] Inner diameter [mm] Atrial cannula for newborns, staged C10V , 3; head 3 Atrial cannula for infants C15V Atrial cannula for small children C19V Atrial cannula for children, staged (with mandrin) Atrial cannula for children, staged (with mandrin) C22V , 12; head 9 C25V , 12; head 9 Atrial cannula (with mandrin) C22V Atrial cannula (with mandrin) C26V Atrial cannula (with mandrin) C30V Arterial cannulas Description Article number Head angle [ ] Body length [mm] Inner diameter [mm] Arterial cannula for newborns, staged C80G , 3; head 3 Graft-adapter cannula for infants C00P Arterial cannula for infants C80G Arterial cannula for small children C80G Arterial cannula for children, staged C60G , 12; head 9 Appendix Arterial cannula for children, staged C85G , 12; head 9 Graft-adapter cannula for children, staged C00P , 12; head 9 Arterial cannula C60G Arterial cannula C85G Arterial cannula, staged C85G , 16; head 12 Graft-adapter cannula C00P Graft-adapter cannula C00P Rev

101 Overview: Product range and combination options Overview: Which cannulas for which pump? Pump: ø connectors [mm] Which pump? Cannula: ø Internal [mm] at transition cannula/pump Which inflow cannula? Which outflow cannula? (Arterial 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) C80G-031 C80G-040 C80G 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) 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) 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 P80M-003 (KS) P80M-004 (KS) 16 C41A-050 (AP) C85G-050 (SO) C00P-050 (GA) a) After cutting, the cannula is identical to C-85G-002 Explanation: PU: PU valve KS: Tilting-disk valve VH: Atrial cannula AP: Apex cannula SO: Stage cannula, original diameter SZ: Stage cannula, diameter after cutting GA: Cannula with graft-adapter 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 Rev

102 Overview: Product range and combination options System accessories Description Article number Vessel model consisting of two pressure vessels 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) Cutting tool Red driving tube; length: 200 cm Blue driving tube; length: 200 cm Tensile stress relieving belt T00L-001 T00L-002 T00C-001 L20H-002 L20H-003 L20Z-001 Driving units Description EXCOR stationary Driving Unit Ikus (230V/50Hz) EXCOR stationary Driving Unit Ikus (115V/60Hz) EXCOR mobile driving system Excor Article number D03I-001 D03I-110 D01E-001 Special range Description Transmitral cannula ø12mm, length: 330 mm Article number C90T-001 Connecting set for cannulas ø 6 mm to ø 9 mm A Connecting set for cannulas ø 9 mm to ø 12 mm A Connecting set for cannulas ø 12 mm to ø 16 mm A Appendix Rev

103 Technical specifications 13.2 Technical specifications Product Manufacturer and distributor Electro-pneumatic ventricular assist Ikus EXCOR VAD with EXCOR stationary Driving Unit Ikus Berlin Heart GmbH Wiesenweg Berlin Germany Classification Class 3 Overall system (excluding pump) Ambient operating temperature + 10 to +30 C, with restrictions up to 35 C Ambient temperature in storage and transport Max. ambient magnetic field - 10 to +50 C 6 h rest phase after transport before commissioning 10 A/m Relative ambient air humidity 45 to 75% Ambient atmospheric pressure 900 hpa to 1060 hpa Pump Dimensions Material see product datasheets 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 Material see product datasheets Silicone; partially textile-reinforced; partially surrounded by suturable polyester velour; with partial flexible metal reinforcement: wire 2 mm, steel Rd ; apex cannula with titanium sheath; mandrin POM Ikus Dimensions (WxHxD) Driving tube (red/blue) Weight Input voltage Power input 46 x 95 x 73 cm (with the laptop closed) 46 x 120 x 73 cm (with the laptop open) Recommended lifespan: 1 year; max.: 500 days 93 kg AC 115 V or AC 230 V (see identification plate) 575 VA Mains power fuse 5 A (115 V) to 3 A (230 V) External alarm connector Protection class Pump frequency Systolic pressure 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 IPX0 (protection against accidental contact not tested, no water protection) 30 to 150 bpm 60 to 350 mmhg Rev

104 Symbols Diastolic pressure Precision of pressure display ± 10% 13.3 Symbols Ikus: Identification plate to 0 mmhg Relative systolic duration 20 to 70% Off-mains operating time Battery charge duration Maintenance interval Max. Ikus service life max. 50 min (at max. 30 C ambient temperature, otherwise less) 6 h 2000 operating hours or 6 months (at max. 30 C ambient temperature, otherwise 1000 operating hours or 3 months) 10 years Symbols on the Ikus identification plate: Application component type B according to DIN EN : A1: A2:1995 (left); certification mark (right) 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 : A1: A2: Marking of Numlock status LED Appendix Example for marking of the Numlock status LED on the laptop Rev

105 EXCOR standard forms implantation record 13.4 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, Berlin, Germany Tel.: +49(0) , Fax: +49(0) , service@berlinheart.de Hospital: City/ Country: Patient data (for Berlin Heart registry) Patient s initials: 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] MAP [mmhg] LVEF % FS % Cl [l/min/m²] NYHA LVEDP [mmhg] LVEDD [mm] Creatinine [mg/dl] Total Bilirubin [mg/dl] Platelet count [ /μl] Leukocytes [ /μl] Implantation Date: Surgeon: 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.: Date: Ikus hours of operation: Signature Followup Date: Weaning O Out of hospital O TX O Expired O Pump replacement 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 Rev

106 EXCOR standard forms implantation record 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) ). Appendix Hospital/City: Date of implantation: Item Lot-No.: Article number EXCOR Blood Pumps with PU valves 10 ml in/out Ø 6 mm P10P ml in/out Ø 9 mm P25P ml in/out Ø 9 mm P30P ml in/out Ø 12 mm P50P ml in/out Ø 12 mm P60P ml in/out Ø 12 mm P80P-001 EXCOR Blood Pumps with Tilting-disk valves 50 ml in/out Ø 12 mm P50M ml in/out Ø 12 mm P60M ml in/out Ø 12 mm P80M ml out/in Ø 12 mm (in/out exchanged) P80M ml in/out Ø 16 mm P80M ml out/in Ø 16 mm (in/out exchanged) P80M-004 EXCOR Apex Cannulas 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) C41A-050 EXCOR Atrial Cannulas 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) C90T-001 EXCOR Arterial Cannulas 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) C00P-050 Accessories 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 L20H-003 Connecting set for Cannulas Ø 6/9 mm A Ø 9/12 mm A Ø 12/16 mm A Rev

107 Standard form: EXCOR pump log 13.5 Standard form: EXCOR pump log Explanations on the pump log transition inflow cannula - inflow connector 2 Only on pumps with PU valves: Inflow stub in front of inflow valve inflow valve 4 inflow stub behind inflow valve area between inflow and outflow stubs 6 remaining area of blood chamber 5 7 transition blood chamber - membrane (directly above the reinforcement ring) outflow stub in front of outflow valve 6 9 outflow valve 10 Only on pumps with PU valves: Outflow stub behind outflow valve 7 11 transition outflow connector - outflow cannula 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 1 small laminar 3 small suture on the inflow valve 6 small specks 8 larger laminar deposits Example: Notation with letter code Rev

108 Standard form: EXCOR pump log EXCOR pump log 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 area between inflow and outflow stubs 5 6 remaining area of blood chamber transition blood chamber - membrane (directly above the reinforcement ring) 8 outflow stub in front of outflow valve 6 9 outflow valve 7 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: Appendix Rev

109 Standard form: EXCOR parameter log 13.6 Standard form: EXCOR parameter log Patient: Lot no. of left pump: Lot no. of right pump: 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 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) Rev

110 Standard form: EXCOR emergency log 13.7 Standard form: EXCOR emergency log Notify hotline! +49(0) This log helps to record malfunctions in the Ikus. 1) General Ikus serial no.: 0 - Elapsed operating hours: Date of next maintenance: Location (clinic): Age of patient: Status of the patient: O stable O deteriorated Support by O UVAD O BVAD 2) Malfunction What is happening / has happened? How did the error occur? When did the error occur? 3) Current status: How is the Ikus working since the error occurred? Currently displayed parameters in the monitoring program 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 How many LEDs are lit up on the charge level indicator? O battery mode (indicator lamp Battery mode lit up) (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 Appendix 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) Rev

111 Standard form: EXCOR emergency log 6) Other noticeable problems: Note Fax: +49(0) Rev

112 Standard form: Blood pump replacement 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. Appendix What 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) 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 <Enter>. In the monitoring program, select the option Drive pause, then confirm with <Enter>. Confirm the decision in the dialog window with <X> or <1>. 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 <Enter>. 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 <Enter> to trigger a single-step. With <Enter>, 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 <Enter>. Move the cursor to OK, then confirm with <Enter>. The system restarts with the set parameters. Observe the pump filling. If necessary, adjust the parameters. Secure all the connections with cable tie straps Rev

113 Additional information: Laptop Panasonic CF 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 Rev

114 Additional information: Laptop Panasonic CF29 Appendix Rev

115 Emissions characteristics 14 EMC tables 14.1 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. Measurement of transient emissions HF emissions according to CISPR 11 HF emissions according to CISPR 11 Emissions of harmonics according to IEC Emissions of voltage fluctuations/flickers according to IEC Compliance Group 1 Class B Class A Conformant Electromagnetic environment - guidelines 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. 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 Rev

116 Electromagnetic immunity - Part Electromagnetic immunity - Part 1 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 Discharges of static electricity (ESD) according to IEC IEC testing level Compliance level Electromagnetic environment - guidelines ± 6 kv contact discharge ± 8 kv air discharge ± 6 kv contact discharge ± 8 kv air discharge 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. Fast transient electrical disturbance variables/bursts according to IEC Surge voltages according to IEC ± 2 kv for mains power lines ± 1 kv for input and output lines ± 1 kv alternate mode voltage ± 2 kv for mains power lines ± 1 kv for input and output lines ± 1 kv alternate mode voltage The quality of the supply voltage should correspond to a typical commercial and hospital environment. ± 2 kv synchronous mode voltage < 5 % U T (>95 % dip in the U T ) for ½ period ± 2 kv synchronous mode voltage < 5 % U T (>95 % dip in the U T ) for ½ period Voltage dips, shortterm interruptions and fluctuations of the power supply according to IEC % U T 60 % dip in the U T ) for 5 periods 70 % U T 30 % dip in the U T ) for 25 periods 40 % U T 60 % dip in the U T ) for 5 periods 70 % U T 30 % dip in the U T ) for 25 periods 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. Magnetic field at the supply frequency (50/60 Hz) according to IEC NOTE < 5 % U T (>95 % dip in the U T ) for 5 seconds < 5 % U T (>95 % dip in the U T ) for 5 seconds 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. U T is the mains power AC voltage before the application of the testing level. EMC tables Rev

117 Electromagnetic immunity - Part 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 testing level Compliance level Derived HF disturbance variable according to IEC 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 [V 1 ]=10 V [V 2 ]=10 V 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 P P Irradiated HF disturbance variable according to IEC V/m 80 MHz to 2.5 GHz [E 1 ]=10 V/m d =1, 2 P 80 MHz to 800 MHz d = 2, 3 P 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 Rev

118 Recommended protection distances 14.4 Recommended protection distances between wearable and mobile HF telecommunications devices and the Ikus 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) Rated power of the transmitter W 150 khz to 80 MHz outside of the ISM bands 150 khz to 80 MHz 800 MHz to 2.5 GHz 800 MHz to 2.5 GHz within the ISM bands d = 0, 35 P d = 1, 2 P d = 1, 2 P d = 2, 3 P 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. EMC tables Rev

119 The most important changes at a glance 15 About these instructions for use 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 (Ikus ver. 2.0) and (ver. 2.1) Version Version Starting and configuring Ikus Connecting the tank unit Setting test parameters Disconnecting the tank unit from Ikus 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 Backup processor reports error Backup processor reports deviating flow measurement on left (or right) Backup processor reports error: flow measurement on left (or right) Backup processor reports incorrect testing Appendix 13.8 Example: Blood pump replacement 13.9 Additional information: Laptop Panasonic CF 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 Rev

120 Explanations 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. About these instructions for use Rev

121 Latest News x14 Rev. 8 This document provides information about changes that have not yet been included in the instructions for use. Date of issue: Replaces: x13 Rev. 7 Product: EXCOR VAD with Ikus stationary driving unit Rev. 2.1 SW 3.40 Accompanying documents: for use Revision 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 Berlin Germany service@berlinheart.de Tel: +49 (0) Fax +49 (0) x14 Rev. 8 1/28

122 Table of contents First page... 3 New structure of the safety information... 3 Safety information Important safety information... 4 Warranty Manufacturer's warranty... 6 Start menu Start menu... 7 Unintended change of the operating mode Pause drive: stop the Ikus temporarily Switching from univentricular to biventricular operation... 7 New transport crate Packaging and transport... 8 De-airing hammer Preparing components and materials Cannula position and transcutaneous exit sites Surgery Transcutaneous tunnel and cannula tunneling tip Surgery Using the connecting set Surgery Anastomosis of inflow cannula with apex Anastomosis of inflow cannula with apex Securing the connections Securing the connections Tie-band gun Securing the connections Anticoagulation therapy in young persons and adults Intensive care and post-operative care Postoperative anticoagulation therapy Postoperative platelet aggregation inhibition therapy Replacing the driveline Replacing the driveline Messages Please check left/right pump and tube The error is only detected by the active (or passive) computer Processor failure. Contact customer service! Additional messages during the start test Replacing the blood pump Replacing the blood pump(s) Replacing the blood pump because of growth of the patient Emergency pulse mode Emergency pulse mode Ikus start test after emergency pulse mode Reading out the log files/data storage media: USB stick Reading out the log files Discontinuation of the mandrin Overview: product range and combination options Technical specifications Technical specifications / x14 Rev. 8

123 First page Changes: New hotline phone number The text has been supplemented. HOTLINE Notify hotline! +49 (0) 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. DANGER Indicates a hazardous situation which, if not avoided, will result in death or serious injury to the patient. WARNING Indicates a hazardous situation which, if not avoided, may result in death or serious injury to the patient. CAUTION Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury to the patient. The device may suffer damage. NOTICE Indicates practices which do not entail personal injury. The device may suffer damage. ADVICE 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 x14 Rev. 8 3/28

124 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 of the instructions for use. Do not reintroduce de-airing needles that have been once removed. Otherwise the membrane may be damaged. See section 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/ x14 Rev. 8

125 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 x14 Rev. 8 5/28

126 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. Warranty 2.5 Manufacturer's warranty 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/ x14 Rev. 8

127 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 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 <Enter>. 2. Navigate cursor to L/R separate. Do not confirm with <Enter>. 3. Navigate cursor to an arbitrary pump parameter. Confirm with <Enter>. 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 x14 Rev. 8 7/28

128 New transport crate 5.8 Packaging and transport Changes: The section has been supplemented. NOTICE Do not dispose of the transport crate! Unloading the Ikus from the transport crate 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. Questions: HOTLINE Notify hotline! +49 (0) 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: kg (approx. 219 lb) 8/ x14 Rev. 8

129 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. Fig. 1 Empty transport crate Fig. 2 Laptop secured 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 x14 Rev. 8 9/28

130 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. Fig. 3 Ikus packed in a plastic bag Fig. 4 Packed white accessory box 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. 10/ x14 Rev. 8

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

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

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

134 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) 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 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 mm 2 12 mm 3 9 mm 4 6 mm Fig. 12 Available sizes of the cannula tunneling tip 14/ x14 Rev. 8

135 INSTRUCTION 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. The sequence of anastomosis and tunneling will change depending on the type of cannula. See section 8.2 ff. of the instructions for use. 1 Dressing forceps 2 Cannula tunneling tip 3 Cannula Fig. 13 Handling the cannula tunneling tip Tunneling cannula with the aid of a tube clamp 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. INSTRUCTION 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. Using the connecting set 8 Surgery Changes: The chapter 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 x14 Rev. 8 15/28

136 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 A to 12 mm 90 mm A to 9 mm 75 mm A to 6 mm 60 mm Tab. 1 Connecting set: minimum lengths of the connecting tube Anastomosis of inflow cannula with apex Anastomosis of inflow cannula with apex Changes: The section has been supplemented. WARNING 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/ x14 Rev. 8

137 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. 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 Fig. 15 Optimum cannula position x14 Rev. 8 17/28

138 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 Fig. 16 section 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 When using an EXCOR connecting set: finish by securing each of the connections with 1 cable tie, following the procedure described above. Fig. 17 Correctly positioned cable tie 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/ x14 Rev. 8

139 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 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; Fig. 19 Checking the settings x14 Rev. 8 19/28

140 If necessary: correct the settings INSTRUCTION 1. Loosen the screw. See Fig. 20, page 20; Remove the safety cap. See Fig. 20, page 20; 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; 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; Replace the safety cap and secure 1 2 with the screw. Fig. 21 Correcting setting 20/ x14 Rev. 8