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Chapter 3 Summary of Clinical Studies

Fig. 3-4

Cohort 1 Competing outcomes

The next figure shows the “Competing Outcomes” for the ECMO control group for
Cohort 1. The longest support time was 20.5 days at which time 75% were weaned
from ECMO for recovery or transplant.

Fig. 3-5

Cohort 1 control group competing outcomes

The following figure shows the “Competing Outcomes” for Cohort 2. Of the 24 Cohort
2 subjects, 21 were transplanted between 3 to 192 days of support. The 2 deaths in

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Summary of Contents for EXCOR Pediatric VAD

Page 1: ...ducts in USA Humanitarian Device Authorized by Federal law for use in the treatment of pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support The effectiveness of this device for this use has not been demonstrated 1000721x09 Revision 8 ...

Page 2: ...This page was left blank intentionally 1000721x09 Revision 8 ...

Page 3: ... version Licenses trademarks and trade names and EXCOR are trademarks of Berlin Heart GmbH They are protected by the relevant legislation in Germany and other countries All other trademarks or brands mentioned in this instruction for use are acknowledged as being the pro perty of the respective owners These rights are specifically recognized and respected whenever such trademarks or brands are men...

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Page 5: ... while on device support 19 1 2 4 Transport outside the clinic 20 1 2 5 Battery replacement and disposal 20 1 3 Obligations of the operator 20 2 General Information 21 2 1 Device description 21 2 2 Indications for use 21 2 3 IDE Clinical Study Summary 21 2 4 Intended operation environment 21 2 5 Contraindications 22 2 6 Potential adverse events 22 2 7 Storage and durability 22 2 8 Battery replacem...

Page 6: ...n univentricular operation 63 5 5 2 Redundant design of pneumatic systems in biventricular operation 64 5 5 3 Control computer with redundancy design 64 5 5 4 Battery operation 65 5 5 5 Manual pump 65 5 5 6 Password protected user profiles access passwords 65 6 Instructions for use Ikus 67 6 1 Start menu 68 6 1 1 Selecting an option in the start menu 69 6 1 2 Configuring user passwords 69 6 1 3 Sa...

Page 7: ...support to VAD support 105 7 2 12 Possible complications 106 7 3 Postoperative drive management 107 7 3 1 After transfer to the ward 107 7 3 2 Follow up treatment 107 8 Implantation Preparations in the operating room 109 8 1 Preparing the components and materials required 109 8 2 Checking and adjusting the settings of the cable tie gun 109 8 3 Unpacking the sterile components 111 8 4 Moving the me...

Page 8: ...py 145 12 3 1 General Considerations 145 12 3 2 Starting anticoagulation therapy 145 12 3 3 Unfractionated heparin therapy i v Patient 12 months 146 12 3 4 Unfractionated heparin therapy i v Patient 12 months 146 12 3 5 Thrombelastography TEG 147 12 4 Low Molecular Weight Heparin 147 12 5 Oral Anticoagulation Therapy only for patients 12 months of age who are taking a full oral diet 147 12 6 Monit...

Page 9: ...e Only limited battery operation 183 14 18 Error messages Circuit breaker and internal battery fuse 183 14 19 Electronic malfunction Contact customer service 183 14 20 Acoustic alarm is not properly recognized 184 14 21 Error no data no reaction from the control computer 184 14 22 Left right flow sensor defective Notify Service 185 14 23 Problem Text 186 14 24 Self test is not completed by passive...

Page 10: ... 16 1 12 Relative systolic duration 217 16 2 Technical specifications 217 16 3 Symbols and tags 220 16 4 Sample copy Ikus Incoming Checklist 221 16 5 Implantation record form 222 16 6 Sample copy EXCOR pump log 227 16 7 Pump performance flow sheet 230 17 EMC tables 231 17 1 Essential Performance 231 17 2 Electromagnetic emissions 231 17 3 Electromagnetic immunity part 1 231 17 4 Electromagnetic im...

Page 11: ...ith EXCOR Note The recommendations in this manual are based on Berlin Heart s experience with the EXCOR The decisions related to implantation the components to be used and patient care remain with the patient s physicians The following pictograms and symbols are used in this instruction for use DANGER Indicates a hazardous situation which if not avoided will result in death or serious injury to th...

Page 12: ...egal regulations only when the defective goods should repeatedly fail or be deemed unacceptable The buyer may not rectify the defects under any circumstances The buyer is entitled to claims for defects only in accordance with item 5 5 of the General Business Terms and Conditions for additional information see section 5 of the Terms and Conditions Warranty period All warranty claims expire after 12...

Page 13: ...n the system EXCOR only use components of this system Never use other components than those delivered by Berlin Heart GmbH Berlin Heart Inc Otherwise the warranty is no longer valid The Ikus and the components of the EXCOR system must not be modified Otherwise the secure function of the system can not be guaranteed The Ikus should not be used adjacent to or stacked with other equipment If adjacent...

Page 14: ...reme caution pulling the Ikus unit backwards i e handle first across the obstruction if necessary To lift the Ikus use only the lifting bars at the lower edge at each side of the unit to hold and lift it Never attempt to lift the Ikus by its handle The Ikus must always be lifted by at least 2 people preferably 4 Rolling the Ikus over sloping surfaces ensure that the person pushing it is strong eno...

Page 15: ...nternal alarm system of the clinic is not failsafe The use of this feature does not release the user from supervising the Ikus and the displayed messages and alarms 1 1 4 Procedural techniques Ikus WARNING Follow the numbered instructions exactly in their sequential order Otherwise there is a risk of functional limitation or Ikus malfunction Protect the Ikus unit against dirt and contamination Pre...

Page 16: ...the tank unit page 94 Otherwise there is a risk that error messages are falsely generated After switching on the Ikus pull the key out of the main switch key switch and store it in a safe place The Ikus power switch toggle switch must be switched on during the first startup and remain set to I position Its position should never be changed Otherwise there is a risk that the batteries will not be fu...

Page 17: ...ient must be accompanied by a person trained to use the manual pump Thus the patient shall be guaranteed care in an emergency To prevent the batteries from aging quickly every period of battery operation should be followed by at least 6 h of mains operation When the battery charge is low the acoustic signal sounds every minute The Ikus must be connected to the mains operation immediately Messages ...

Page 18: ...s driving tubes de airing set de airing hammer tube connecting set membrane set The external packaging and the outer surface of the outer sterile packaging are not sterile These 2 packaging layers must be removed before the inner sterile packaging containing the product is handed over to the sterile field Otherwise there is a risk that the sterile field will be contaminated 1 1 6 Procedural techni...

Page 19: ...he blood flow direction There is a risk of injury to the patient and severe pump malfunction if the titanium connectors on the end of the inflow and outflow stubs are not connected to the appropriate cannulae Do not touch or manipulate the blood pumps and cannulae with pointed or sharp edged objects surgical instruments wire brushes etc Otherwise there is a risk of blood pump and cannula leakage D...

Page 20: ... be clamped with a gauze sponge When using a cannula extension set a connecting set it may be necessary to shorten the respective connecting tube but the minimum length must be maintained See Tab 1 1 page 10 Article Diameter Diameter reduction Minimum length Cannula extension set A06 006 6 mm 55 mm A09 009 9 mm 60 mm A12 012 12 mm 75 mm Connecting set A06 009 9 to 6 mm 60 mm A09 012 12 to 9 mm 75 ...

Page 21: ... with a rate 60 bpm without constant supervision Secure each connection between blood pump and cannula with at least one cable tie as soon as the proper function of the EXCOR is established see section 9 11 Securing the connections page 130 Otherwise there is a risk of loose connections and inadequate blood supply to the patient At least every 4 hours visually check that the blood pump s is are fi...

Page 22: ...Caps Lock key of the laptop is deactivated The status LED on the laptop marked with a lock and or a number e g 1 should not be lit Otherwise there is a risk of incorrect inputs Only use USB sticks included within the delivery of the EXCOR to store data Do not use any other USB sticks with the laptop Risk that a wrong USB stick is not recognized If a wrong USB stick is recognized then it may not be...

Page 23: ...water or fluids to cool the Ikus Otherwise there is a risk of a short circuit or a malfunction of the device 1 1 8 Procedures to minimize risk of thrombosis WARNING Ensure complete filling ejection of the pump When using staged cannulae or a cannula extension set connecting set the pumping rate may not be greater than the respective value found in Tab 16 9 page 216 as the pump will not eject its f...

Page 24: ...in Heart GmbH Berlin Heart Inc or those authorized by Berlin Heart GmbH For this reason this document does not contain any circuit or wiring diagrams The maintenance is performed based upon the Maintenance Instructions This document also includes a technical description of the Ikus Only replacement parts approved by the manufacturer may be used for repairs and servicing Otherwise there is a risk o...

Page 25: ...culation danger of pulmonary edema Message Left right flow sensor defective Notify Service Do not operate the Ikus without supervision Otherwise an insufficient support of the patient might not be detected If the Ikus is operating in emergency pulse mode the user must immediately visually check the blood pump s to determine whether the pump s are filling and ejecting completely If one pump is not ...

Page 26: ... right pump must also be stopped while the pump is being replaced in order to avoid overloading the pulmonary circulation danger of pulmonary edema If air or blood collects between any of the layers of the membrane replace the blood pump Otherwise support may be inadequate 1 1 13 Driving blood pump s with the manual pump WARNING The use of the manual pump is only permitted for medical personnel tr...

Page 27: ...tables page 231 When using an RFID device in the immediate environment of an Ikus in operation please make sure to keep a distance of at least 1 m For further information please refer to chapter 17 EMC tables page 231 Protect the Ikus against temperatures below 10 C and above 30 C this includes extreme temperature changes and overheating e g direct sunlight or from heaters Otherwise there is a ris...

Page 28: ...wever these procedures and therapies must only be applied after consultation with the treating physician Radiotherapy Nuclear diagnostics nuclear therapy Electro stimulation therapy Therapeutic ultrasonic treatment e g lithotripsy External defibrillation The following procedures and therapies have been tested in regard to their interaction with the Ikus and no harmful effects were found however th...

Page 29: ... every 4 hours check visually that the blood pump s is are filling and ejecting completely over a period of several pump cycles If a pump is not filling and or ejecting completely then take the appropriate corrective action Educate the patient family and caregiver to avoid pulling kinking or any activity that could put stress on the cannula Remind them periodically of the importance of protecting ...

Page 30: ...the respective regulations 1 3 Obligations of the operator WARNING Only qualified medical personnel trained specifically in the use of the system are permitted to work with EXCOR Training courses can be arranged with Berlin Heart Inc CAUTION The operator i e the hospital using the system is responsible for instruction and care of the patient The patient must be instructed on safety risks and cauti...

Page 31: ...ood flow Pulse rate systolic drive pressure diastolic suction pressure and the relative systolic duration can all be monitored and adjusted on the driving unit 2 2 Indications for use The EXCOR is intended to provide mechanical support as a bridge to cardiac transplantation for pediatric patients Pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidat...

Page 32: ...enal Dysfunction Respiratory Failure Right Heart Failure Arterial Non CNS thromboembolism Venous Thromboembolism Event Wound Dehiscence Device Malfunction 2 7 Storage and durability WARNING The expiration date of each EXCOR product is found on the product labels located on both the outer and inner packaging The pumps cannulae and accessories must not be used after the expiration date and even not ...

Page 33: ...od pump s The warranty is no longer valid if the Ikus has been opened or serviced by persons who are not members of the Berlin Heart GmbH Berlin Heart Inc service staff and or who have not been authorized by the Berlin Heart GmbH service department to do so If an ambient temperature of 30 C is continuously exceeded during ongoing operation the maintenance interval will be reduced Components Produc...

Page 34: ...e interval Expiration date Warranty Cannulae no limitation single use product x 3 years 1 year Accessories single use product x 3 years first use Tab 2 1 Product life maintenance interval expiration date warranty Please dispose components according to local regulations and site policies 1000721x09 Revision 8 24 ...

Page 35: ...mark Spain Finland France Great Britain Greece Hungary Italy Lithuania Netherlands Poland Portugal Romania Sweden Slovakia Turkey Argentina Australia Azerbaijan Brazil Canada Chile Taiwan China Hong Kong Israel Iran New Zealand Serbia Russia Saudi Arabia and South Africa The EXCOR has not been removed from the market in any country 3 5 Potential Adverse Effects Serious adverse events SAEs for all ...

Page 36: ...Chapter 3 Summary of Clinical Studies Tab 3 1 Serious adverse event summary per cohort 1000721x09 Revision 8 26 ...

Page 37: ...Chapter 3 Summary of Clinical Studies Tab 3 2 Serious adverse event summary per cohort table continued 1000721x09 Revision 8 27 ...

Page 38: ...ulation of 48 subjects aged 0 16 years consisted of 24 subjects with a body surface area BSA 0 7 m2 Cohort 1 and 24 subjects with a body surface area BSA 0 7 m2 to 1 5 m2 Cohort 2 A third cohort of subjects was enrolled under Compassionate Emergency Use regulations and is classified as Cohort 3 These subjects followed the study protocol unless otherwise noted within the approval documentation for ...

Page 39: ...ated GFR despite optimization of subject volume status b Decline in nutritional status as defined by a sustained 7 days inability to tolerate an enteral nutritional intake sufficient to provide at least 75 of the prescribed caloric needs for the subject or signs of nutritional compromise cachexia nutritional weight loss despite appropriate intervention c Decline in mobility ambulation as defined b...

Page 40: ...D or other hemodynamically significant lesion considered technically challenging to repair at the time of device implantation as determined by the principal investigator 12 Documented heparin induced thrombocytopenia HIT or idiopathic thrombocytopenia purpura ITP or other contraindication to anticoagulant antiplatelet therapy 13 Documented coagulopathy e g Factor VIII deficiency disseminated intra...

Page 41: ...ects BSA 0 7m2 enrolled and 53 larger sized subjects BSA 0 7 to 1 5 m2 enrolled Tab 3 4 Subject enrollment Note Enrollment in Cohorts 1 CAP 3A 3B IDE and non IDE are supportive data and are included only in the safety summary tables 1000721x09 Revision 8 31 ...

Page 42: ...ge from 2 6 to 45 6 months while the larger group ranged in age from 51 to 192 months or 4 2 to 16 years The weight range for Cohort 1 was 3 6 to 13 6 kilograms with a BSA range of 0 23 to 0 62 m2 and the weight range for Cohort 2 was 16 0 to 58 1 kilograms with a BSA range of 0 71 to 1 66 m2 The most predominant cardiac diagnosis for Cohort 1 was dilated cardiomyopathy 79 2 and the majority of th...

Page 43: ...Chapter 3 Summary of Clinical Studies Tab 3 5 Demographic data summary a 1000721x09 Revision 8 33 ...

Page 44: ...Studies Tab 3 6 Demographic data summary b Pre implant support for the subjects is detailed in the following table ECMO support was used pre implant for 25 of Cohort 1 subjects and 33 3 of Cohort 2 subjects 1000721x09 Revision 8 34 ...

Page 45: ...24 or 89 6 overall 43 48 The following table summarizes the survival to transplant successful recovery for each primary Cohort ITT and PP as well as their matched ECMO control groups Three 3 of the Cohort 1 subjects 12 5 failed 2 deaths and 1 weaned subject with unacceptable neurological outcome at 30 days post explantation compared to 12 of the 48 25 patients in the matched ECMO control group The...

Page 46: ...p for Cohort 2 was on ECMO for a median of 4 7 days and a maximum of 27 5 days compared to the primary cohort subjects who were supported a median of 42 5 days and a maximum of 192 days Seventeen 17 of the 24 71 subjects in Cohort 2 were supported longer than the entire ECMO control group i e longer than 27 5 days 1000721x09 Revision 8 36 ...

Page 47: ...n of the ITT groups to their respective matched ECMO control group survival rates were both statistically significant log rank p value 0 0001 Therefore there is a significantly higher survival rate of Cohort 1 and 2 subjects as compared to their respective ECMO control group 1000721x09 Revision 8 37 ...

Page 48: ...e following figures display the Kaplan Meier curves for the endpoint of death weaned with unacceptable outcome for both Cohort 1 ITT and Cohort 2 ITT and their respective ECMO control groups Fig 3 2 Cohort 1 Survival 1000721x09 Revision 8 38 ...

Page 49: ...endpoints The following figure shows the Competing Outcomes for Cohort 1 The curves represent each of the outcomes and at any time point the sum of the proportions of outcomes equals 100 Of the 24 Cohort 1 subjects 21 were transplanted between 1 to 174 days of support The 2 deaths in this Cohort occurred at 0 and 38 days post implant One subject was weaned after 146 days due to poor prognosis 1000...

Page 50: ... Cohort 1 The longest support time was 20 5 days at which time 75 were weaned from ECMO for recovery or transplant Fig 3 5 Cohort 1 control group competing outcomes The following figure shows the Competing Outcomes for Cohort 2 Of the 24 Cohort 2 subjects 21 were transplanted between 3 to 192 days of support The 2 deaths in 1000721x09 Revision 8 40 ...

Page 51: ...ct was successfully weaned to recovery after 9 days Fig 3 6 Cohort 2 competing outcomes The next figure shows the Competing Outcomes for the ECMO control group for Cohort 2 The longest support time was 27 5 days at which time 67 were weaned from ECMO for recovery or transplant 1000721x09 Revision 8 41 ...

Page 52: ...04 10 10 The summary statistics of time of eligible support are detailed in the following table Tab 3 9 Days of transplant eligible support The second objective was to show the ability to de intensify concomitant hemodynamic support At each visit the subject s status was recorded with the following choices sedated intubated on ECMO awake ambulating or eating The following table summarizes those ch...

Page 53: ...of the Cohort 1 subjects was 1411 days There were 96 serious adverse events SAEs for this cohort yielding a rate of 0 068 events per patient day The 95 Poisson confidence interval was calculated as 0 055 0 083 The total time on device for Cohort 2 was 1376 days There were 109 SAEs for this cohort yielding a rate of 0 079 events per patient day with the confidence interval as 0 065 0 096 A summary ...

Page 54: ...ubsequently falls to a nadir at around 2 3 months of age due to decreased RBC production Anemia in acute or critical illness may be exacerbated by numerous factors including blood loss due to hemorrhage or sampling reduced RBC production due to nutritional deficits inflammatory processes or low erythropoietin levels and increased RBC turnover due to hemolysis Cohort 1 subjects had a pre implant hi...

Page 55: ... from support as a result of the neurological injury Of the remaining 6 subjects PSOM exams were performed post explant and 1 had no deficit 50 days post explant 2 had mild deficits 27 and 49 days post explant 1 had moderate deficit 357 days post and 2 had severe deficits PSOM scores of 10 at 29 and 38 days post This table summarizes the status information Tab 3 11 Summary of neurological event st...

Page 56: ...of replace ment Replace ments per Subject Total Days on Device Replacem ents per Days on Support Time to first replaceme nt days primary 48 25 43 0 9 1 2 2787 0 02 0 03 24 1 19 7 Cohorts 50 0 0 4 0 00 0 13 4 105 IDE 109 57 114 1 1 1 4 6350 0 02 0 03 19 1 16 9 Cohorts 52 3 0 6 0 00 0 18 2 105 Non IDE 95 36 58 0 6 1 0 7240 0 01 0 03 41 9 44 6 Cohorts 37 9 0 4 0 00 0 27 2 198 Total 204 93 172 0 8 1 2...

Page 57: ...d SAEs 42 of the 48 subjects supported by the EXCOR were adequately supported to transplant and 1 subject was able to be weaned successfully from the device after 9 days of support yielding an 89 6 success rate 43 48 The device supported children safely to cardiac transplantation for a median transplant eligible time of 27 5 and 42 5 days for cohort 1 and 2 respectively Only one subject was tempor...

Page 58: ...ime to await transplant and improved hemodynamics allowing removal of pre implant hemodynamic support allowing for increase time awake ambulating and eating contributing to post implant transplant eligible wait times These far reaching benefits outweigh the risks associated with the adverse events that occurred 3 7 Post Approval Study Summary 3 7 1 Study Objective The purpose of the Post Approval ...

Page 59: ... met regularly during the course of the study to adjudicate the protocol specified SAEs major bleeding major infection and neurological dysfunction events and device malfunctions The CEC also reviewed and assigned cause of death to any subject who died as a result of withdrawal of device support Primary Efficacy Objective Endpoint The primary effectiveness objective for the study was to assess the...

Page 60: ...of 39 Events Subject 39 Adjudicated SAEs Major Bleeding 23 16 41 0 0 59 Major Infection 20 15 38 5 0 51 Localized non device 3 3 7 7 0 08 Percutaneous Site and or Pocket Infection 8 6 15 4 0 21 Internal Pump Component Inflow or Outflow Tract Infection 2 2 5 1 0 05 Sepsis 7 7 17 9 0 18 Neurological dysfunction 17 13 33 3 0 44 TIA 0 0 0 0 0 00 Ischemic CVA 8 6 15 4 0 21 Hemorrhagic CVA 5 5 12 8 0 13...

Page 61: ...her 9 8 20 5 0 23 TOTAL 102 32 82 0 2 36 Tab 3 16 EXCOR Pediatric Post Approval Study Serious Adverse Events 3 7 8 2 Primary Efficacy Endpoints Twenty seven 27 of the 39 69 2 subjects were successfully transplanted or weaned from the device Total support time ranged from 0 to 457 days with an average time of 108 1 days standard deviation 118 9 and median of 63 days IQR 20 160 The following table d...

Page 62: ... major infection neurological dysfunction as well as device malfunctions and deaths Follow up rate was 100 as all subjects remained in the hospital while on device support and therefore all follow up visits were conducted Weaknesses The enrolled subjects showed a higher risk profile when compared to the IDE cohort and were smaller younger spent longer time on support and more patients presented wi...

Page 63: ... blood pump 2 3 driving tube 4 Ikus 3 4 Fig 4 1 EXCOR shown in situ as a biventricular assist device in pediatric application Overview The blood flows from the atrium or the ventricle through the inflow cannula into the blood chamber of the pump and then from this blood chamber through the outflow cannula into the aorta or into the pulmonary artery A driving tube is used to connect the air chamber...

Page 64: ...ce CBAS coating The transparent casing of the blood pump allows easy visual monitoring of the filling and emptying of the blood chamber The blood pump is equipped with a de airing nipple which is used for de airing the blood chamber when the pump is being commissioned The air chamber of the pump is equipped with a driving tube connector This connector is used to connect the blood pump to the drivi...

Page 65: ...sories are required in order to commission and operate EXCOR 1 driving tube PVC for each blood pump 2 tank units 1 accessory T00L 002 set which includes membrane set de airing set 2 x trocar 2 x de airing tube de airing hammer tube connecting set cable ties cable tie gun There is enough material in 1 accessory set T00L 002 to commission 2 EXCOR blood pumps 1000721x09 Revision 8 55 ...

Page 66: ...Chapter 4 Description blood pump cannulae and accessories This page was left blank intentionally 1000721x09 Revision 8 56 ...

Page 67: ... while the 3rd serves as an emergency backup Each pneumatic system includes a compressor pressure and suction limiters pressure and vacuum cylinders control electronic control valves The compressor the pressure and the suction limiters deliver constant pressure conditions in the pressure and vacuum cylinders The control valves at the outlet of each cylinder allow optimal adjustment of the positive...

Page 68: ...ovided to be used for reading out and storing LOG files Do not under any circumstances use any other USB stick on the Ikus laptop It is not permitted to use the USB stick for purposes other than reading out and storing the LOG files on the Ikus Never connect other USB devices e g wireless technology to the USB port of the laptop than the delivered USB stick If the USB stick is no longer available ...

Page 69: ...s operation indicator Illuminated when using power supply default situation 5 Power switch toggle switch In this switch position I position the drive is operated through the mains The batteries are charged at the same time In this switch position 0 position the mains power supply is interrupted Ikus works in battery operation 6 Mains power connector with plug clip The Ikus is connected to the main...

Page 70: ...el Main switch key switch 0 I and power switch toggle switch WARNING To prevent the batteries from being discharged by mistake ensure that the power switch toggle switch is set to I position even if the Ikus is set to 0 position at the main switch key switch While the Ikus is being operated keep it connected to the stationary protective ground via the connector Potential equalization The main swit...

Page 71: ... information when maintenance is due 5 Battery charge indicator 7 yellow LEDs indicate the battery charge state see Fig 5 3 page 61 The red LED lights up when the batteries are completely discharged Fig 5 4 Battery charge indicator and operating hour counter The LEDs of the running time display correspond to the maximum technically possible battery running time However the maximum permitted off ma...

Page 72: ...y the system with power independently of the mains for a maximum of 30 minutes Whenever the Ikus is being run in battery operation an acoustic signal sounds at 10 minute intervals When the battery charge is low the acoustic signal sounds 2 times per minute 5 3 Operating modes 5 3 1 Univentricular operation In univentricular operation the driving tube of the blood pump is always connected to the re...

Page 73: ...ream of data on the system s condition as well as information on events and function faults At the same time relevant data is stored on the hard disk for subsequent evaluation A detailed description of the monitor program is given in chapter 6 Instructions for use Ikus page 67 Fig 5 5 Laptop Fig 5 6 Monitoring program 5 5 Safety 5 5 1 Redundant design of pneumatic systems in univentricular operati...

Page 74: ...c systems fail while in biventricular operation the remaining system will drive both blood pumps In this case the Ikus will be operated in synchronous mode with a 250 mmHg systolic pressure 100 mmHg diastolic pressure 70 bpm and a relative systolic duration period of 40 5 5 3 Control computer with redundancy design The control computers are also designed to provide backup redundancy The Ikus syste...

Page 75: ... monitor program showing the time the system has already been running in battery operation The LEDs on the control panel of the handle show the charge state of the batteries 5 5 5 Manual pump If a working Ikus is no longer available the blood pump s can also be temporarily operated even in BVAD mode by the manual pump supplied with the system see section 15 5 Driving blood pump s with the manual p...

Page 76: ...Chapter 5 Description Ikus This page was left blank intentionally 1000721x09 Revision 8 66 ...

Page 77: ...he information and messages in the message window of the monitor program at least every 4 hours If there is a message that indicates action must be taken take the appropriate action and if necessary contact the Berlin Heart Inc emergency hotline When switching on the Ikus always switch the Ikus on first and then the laptop and not vice versa NOTICE For details on commissioning the system see chapt...

Page 78: ...the Numeric Lock 6 1 Start menu 1 Press NumLk After the laptop is started it will display the menu Select language Fig 6 4 Select language Afterwards the start menu will open up and offer the following options Fig 6 5 Start menu 1 Start program Select this option to start the monitor program 1000721x09 Revision 8 68 ...

Page 79: ...art menu After starting the monitor program 1 1 Start program in the start menu the user has to log in with the user ID and password IMPORTANT Before user profiles 2 2 Entry codes can be entered the initial user must first log in with user ID and password of the default user profile IMPORTANT The default user profile is enclosed in the password envelope This envelope can be found in the accessory ...

Page 80: ...s Enter to con firm 6 Repeat the entry and confirm with Enter 7 If it is necessary repeat steps 3 to 5 in order to configure additional user pro files 8 To conclude and confirm all entries press the 0 key The passwords have now been assigned to the respective user IDs The start menu is shown again 9 In the start menu select option 1 Start program 1 to return to the monitor program 10 Enter user ID...

Page 81: ... select 5 Change date or time 5 3 Move the cursor to the desired values using the keys Adjust the value with 1 and confirm with Enter Additional options changing date or time Key Function F6 Switch between input field date and time fields F10 Save settings and exit ESC Cancel and return to start menu Tab 6 2 Options changing date or time 6 2 Basic instructions for monitor program 6 2 1 Starting th...

Page 82: ... first commissioning of the Ikus IMPORTANT The Ikus performs a self test of the alarm circuit for each login procedure If the self test is completed successfully the message Acoustic alarm OK appears a few seconds later IMPORTANT The self test does not occur if at the time of login an alarm is pending that was muted with the button Mute alarm see section 5 2 2 Display and operating panel page 61 I...

Page 83: ...gin Cautionary measure To ensure patient s safety the user always has to log out of the monitor program before leaving the vicinity of the system 6 2 5 Standard view monitor program WARNING The displayed pressure graphs refer to the pneumatic pressures generated internally by the system and are given in millimeters of mercury mmHg They do not display the patient s blood pressure and cannot replace...

Page 84: ...time will not be displayed again when the program is restarted The messages can be recalled by Berlin Heart s service department Monitor program functions Monitor and control system If required parameter adjustment systolic pressure diastolic pressure rate biventricular operating mode synchronous mode asynchronous mode separate mode left right View messages Acknowledge messages Pause drive Switch ...

Page 85: ...5 Select cannulae size The fields highlighted in red in the pop up menus Select pump size and Select cannulae size can be chosen However they are not the recommended option for each individual case see section section 16 1 10 Maximum rates for the pump cannula combinations page 216 and section 16 1 11 Blood pump combinations in biventricular mode page 217 In individual cases consideration is to be...

Page 86: ...INSTRUCTION 1 Use the keys to move the cursor to the desired field in the parame ter table The selected field is given a colored background 2 Use the Bild Bild keys to adjust the value then press Enter to confirm The system will now operate using the new value 3 Visually check that the blood pump s is are filling and ejecting completely over a period of several pump cycles Fig 6 16 Parameter table...

Page 87: ...Drive pause stopping the Ikus temporarily IMPORTANT When restarting the system from a separate mode there can be an unintentional switch to the synchronous mode although L R separate continues to be displayed The pressure graphs however distinctly indicate the synchronous mode INSTRUCTION 1 Select Drive pause then press Enter to confirm Respond to the prompt in the dialog window by pressing the X ...

Page 88: ...ated It is only possible to select Pause left INSTRUCTION 1 Select Pause left or Pause right as required then press Enter to confirm Respond to the prompt in the dialog window by pressing the X key or the 1 key The selected pump will stop The view Pump size and single step mode is displayed 2 To restart the pump at least once Step left or Step right respectively has to be performed see section 7 2...

Page 89: ...efer to section 6 5 1 Routine start test when not in operation page 83 Otherwise there is a risk that the Ikus no longer functions correctly 6 4 Switching between mains and battery operation WARNING The Ikus is designed for stationary operation and to be run on mains Do not run it on battery operation unless this is absolutely necessary e g when moving the patient within the clinic or during a mai...

Page 90: ...w LEDs red LED to the left of yellow LEDs IMPORTANT Whenever the Ikus is being run on battery power an acoustic signal sounds at 10 minute intervals These signals can be either acknowledged on the laptop or muted by pressing the button Mute alarm on the operating panel IMPORTANT Battery charge indicator 7 yellow LEDs indicate the battery charge state see above The red LED lights up when the batter...

Page 91: ...ttery power supply minute intervals operation has been reached Change to mains operation Message Batteries Batteries have reached maximum possible discharged use low charge state 2 runtime only a few power supply times per minute repeatedly minutes Switch to mains operation immediately yellow LED blinks left Batteries are about to reach maximum possible runtime Prewarning Switch to mains operation...

Page 92: ...03 The patient customized parameters have to be adjusted again INSTRUCTION 1 The pump which is to be connected must be already de aired and connected to the cannulae 2 In the monitor program select the option Drive pause see Fig 6 17 page 77 and press Enter to confirm Confirm the selection in the dialog window by pressing X or 1 The active pump will stop The view Select operating mode appears 3 Op...

Page 93: ...an operating LOG file 7 Wait until the LOG file is complete message Switch off drive with main key switch 8 End the monitor program and switch off the laptop 9 All of the yellow battery LEDs are lighted Switch off the Ikus To do so set the main switch key switch to 0 position Not all yellow LEDs are lit up Leave the Ikus on the power supply until all of the yellow LEDs light up Then set the main s...

Page 94: ...ys be lifted by at least 2 people preferably 4 Rolling the Ikus over sloping surfaces ensure that the person pushing it is strong enough to push the Ikus in a controlled manner The slope of the surface may not be steeper than 10 exception packing unpacking of the Ikus into from the transport crate Otherwise there is a risk of injury to the transporting persons or of damaging the Ikus If it is nece...

Page 95: ... crate Ikus Accessories 1 Instruction for use supplied separately 2 Tank units supplied separately 2 Keys 1 Power cable 1 Alarm connector 1 Envelope with password Also see section 16 4 Sample copy Ikus Incoming Checklist page 221 6 7 1 Unloading the Ikus from the shipping crate NOTICE Do not discard the shipping crate INSTRUCTION 1 Follow inspection steps per Ikus Incoming Checklist 2 Place the cr...

Page 96: ...in the main switch key switch in the 0 position Dimensions of the Ikus W x H x D 46 x 95 x 73 cm approx 18 5 x 37 5 x 29 inches with laptop cover down Weight of the Ikus approx 100 6 kg approx 219 lbs INSTRUCTION 1 Place the crate with its back against a wall and or lock the brakes to prevent the crate from moving dur ing loading 2 Open the door latches and swing front door open to the left Unlatc...

Page 97: ... closed and in parking position Fig 6 23 Prepare the laptop 4 Line up the Ikus with the ramp Push it upward on the handle bars all the way into the crate Fig 6 24 Line up the Ikus 5 Engage the Ikus front wheel brake pushing the lever down 1000721x09 Revision 8 87 ...

Page 98: ...structions for use Ikus 6 Place the accessory box in front of the Ikus top of the bottom Fig 6 25 Place the accessory box 7 Reattach the securing plate Fig 6 26 Reattach the securing plate 1000721x09 Revision 8 88 ...

Page 99: ...ions for use Ikus 8 Lift up the ramp Fig 6 27 Lift up the ramp 9 Fix the ramp with the safety retainer Fig 6 28 Fix the ramp 10 Close the front door and apply the latches Fig 6 29 Close the door 1000721x09 Revision 8 89 ...

Page 100: ...fection of the Ikus WARNING Prevent liquids from spilling into the Ikus Otherwise there is a risk of an electric shock and of a malfunction of the Ikus NOTICE Do not use any corrosive or colored solutions or organic solvents to clean the Ikus as they may alter the surface of the product Ikus can be cleaned by wiping disinfection with an alcohol containing solution Omit the air vents 1000721x09 Rev...

Page 101: ...UCTION 1 Clean Ikus by wiping disinfection with an alcohol containing solution e g Bacillol plus IMPORTANT Do not expose display and keyboard to direct spray jet but use a cloth that is moistent with disinfecting agent 1000721x09 Revision 8 91 ...

Page 102: ...Chapter 6 Instructions for use Ikus This page was left blank intentionally 1000721x09 Revision 8 92 ...

Page 103: ...ion check that the ambient condi tions are suitable see section 16 2 Technical specifications page 217 Keep all driving tube connectors covered at all times when not in use NOTICE This chapter describes the technical aspects of commissioning the system as well as perioperative and postoperative drive management When commissioning the system it is vital to observe the instructions given in chapter ...

Page 104: ...ts left blood pump red 2 driving tube connector sockets right blood pump blue 3 button Circuit breaker 4 mains operation indicator 5 mains power switch toggle switch 6 mains power connector 7 main switch key switch I O 8 connector Equipotential bonding 9 connector External alarm Nurse call Fig 7 1 Connection panel 7 1 1 Connecting the tank unit Fig 7 2 Tank unit IMPORTANT 2 separate tank units are...

Page 105: ...after the laptop is switched on 4 Select the desired language by pressing the corresponding number key It is not necessary to press Enter to confirm this selection 5 The start menu is displayed on the laptop 7 1 3 Starting the monitor program INSTRUCTION 1 Select the 1 Start program option 1 in the start menu 2 Enter user ID and password confirm with Enter The Ikus will carry out a start test 3 Wa...

Page 106: ...op or mute it by pressing the button Mute alarm on the operating panel 5 In operating room Reconnect the Ikus to the power supply If Ikus has detected a fault NOTICE An overview of the messages that might occur during the start test is given in section 14 25 Error messages during the start up test page 187 The display FAULT in the parameter table indicates that the start test has detected a fault ...

Page 107: ...7 page 100 In univentricular mode a connector seal test is first performed the Ikus checks whether the driving tube connector socket with the blue marking has been sealed Univentricular operation connector seal test NOTICE The Ikus will repeat the connector seal test up to 3 times If the test is still not successful the system will switch itself off Please contact the emergency hotline HOTLINE Not...

Page 108: ...t Inc Clinical Affairs Fig 7 4 Select the pump size INSTRUCTION 1 In the pop up menu select the desired pump size with 2 In biventricular mode Using the cursor keys move to the field marked right pump select the desired pump size with the cursor keys 7 2 4 Select the cannula size NOTICE The sizes written in red ink in the pop up menu Select the inflow and outflow cannula sizes can be chosen Howeve...

Page 109: ... cannula size with 4 Move cursor with to the pop up menu Cannula out for the right pump With select the outflow cannula size for the right pump 7 2 5 Display pump and cannula sizes It s possible to display the selected pump and cannula sizes on the laptop screen INSTRUCTION 1 Press F10 to shut down the monitor program Confirm the decision in the dialog window by pressing the X key or the 1 key 2 T...

Page 110: ...and setting parameters Fig 7 6 Display pump and cannula sizes 7 2 6 Setting the start up parameters WARNING To connect the blood pump s always set the start up parameters Fig 7 7 Pump size and single step mode 1000721x09 Revision 8 100 ...

Page 111: ...ave been connected to the pump see section 9 9 Connecting the blood pumps to the cannulae page 128 INSTRUCTION 1 Open the driving tube connector marked in red univentricular or both connec tors biventricular To do so pull the seal plugs out of the connector s 2 Connect the driving tube to the Ikus To do so push the plug of the driving tube into the connector The sound of the plug snapping into pla...

Page 112: ...ter repeatedly to trigger further single steps until all air has been removed from the pump s If the blood pump is not filling sufficiently ensure there is suffi cient preload and if necessary increase the diastolic pressure 5 In biventricular mode Move the cursor to the field Step right Repeat the pro cedure for the 2nd pump Transition to continuous pumping mode is not yet possible because OK fie...

Page 113: ...TRUCTION 1 Observe the left blood pump Is the pump ejecting completely If not increase the left driving pressure if necessary 2 Observe the right blood pump Is the pump ejecting completely If not increase the right driving pressure if necessary Observe Action measure Right pump Is the pump filling properly see below If not check the filling pressure central venous pressure CVP CVP too low substitu...

Page 114: ... colored background 2 Use the or Bild Bild keys to adjust the value then press Enter to confirm the input Parameter Range possible changes value by Bild Bild changes value by Systolic pressure mmHg driving pressure 60 to 350 2 5 25 Diastolic pressure mmHg suction pressure 0 to 100 2 5 25 Rate bpm 30 to 150 1 10 Relative systolic duration 20 to 70 1 10 Tab 7 5 Parameter s possible adjustments In bi...

Page 115: ...er of the cannulae used The following values are merely guideline values they may not be appropriate in each individual case Systolic pressure mmHg left right Diastolic pressure mmHg left right Rate bpm Rel systolic duration left right 220 150 40 40 80 40 40 Tab 7 6 Recommended guideline values for normal operation ADVICE Remove the de airing needle after all air has been removed from the blood pu...

Page 116: ...deterioration in filling behavior must be identified and addressed NOTICE Manipulations during implantation can severely influence the inflow temporarily wait for the situation to stabilize before adjusting the values INSTRUCTION 1 Evaluate volume status and transfuse if necessary Evaluate and if necessary correct the cannula position Pump filling deteriorates when thorax is closed If atrial cannu...

Page 117: ...uction pressures Good filling means that the suction pressure is adequate Stable ejection at normal arterial blood pressure means that the driving pressure is adequate WARNING At least every 4 hours visually check that the pump s is are filling and ejecting completely over a period of several pump cycles If a pump is not filling and or ejecting completely appropriate measures are to be taken NOTIC...

Page 118: ...Chapter 7 Commissioning the Ikus and setting parameters This page was left blank intentionally 1000721x09 Revision 8 108 ...

Page 119: ...he trocar heavy scissors towel clamp tube clamp other instruments and equipment as required for open heart surgery EXCOR components and accessories blood pump s each with a pump seal 1 driving tube for each blood pump univentricular driving tube red biventricular 1 red driving tube and 1 blue driving tube inflow cannula e atrial or LV apex cannula outflow cannula e accessory set T00L 002 for blood...

Page 120: ...NSTRUCTION 1 Check if the following values are set coarse adjustment on STD 2 fine adjustment on 5 1 1 2 Fig 8 2 Checking the adjustment 2 In the case of deviations loosen the screw 4 and disassemble the locking cap 3 3 4 Fig 8 3 Disassemble the locking cap 1000721x09 Revision 8 110 ...

Page 121: ... use sterile components which have been delivered in undamaged sterile condition sterile packaging intact expiration date not expired Only use blood pumps which have an undamaged aluminum coated outer packaging INSTRUCTION 1 Pump a non sterile person opens the aluminum coated package and removes the pump in its double sterile packaging 2 The non sterile person opens the outer sterile package 3 A s...

Page 122: ...nector of the blood pump 4 Remove all air from the air chamber of the pump The blood pump membrane is now in the end of diastole position 5 Seal the adapter tube with a tube clamp in order to keep the membrane in this position 8 5 De airing the blood pump WARNING Make sure that no particles or liquids enter the air chamber of the blood pump Otherwise the membrane may be damaged and the patient may...

Page 123: ...p s de airing nipple Never turn the trocar when inserting it this increases the risk of removing a large piece of the silicone material in the de airing nipple 3 Remove the obturator 4 Withdraw the de airing needle by approx 2 mm IMPORTANT The tip of the cannula should still be visible in the blood chamber 5 Use the suture to fix the de airing needle to the de airing nipple 6 Remove the adapter tu...

Page 124: ... stopcock end of the de airing tube 5 Slowly fill the pump with sterile injectable saline Rock the pump back and forth to move any bubbles to the outflow stub 6 Close the stopcock on the de airing tube 7 Tap the blood pump body gently in order to free all remaining bubbles Remove all air from the pump through the outflow connector 8 Use the seal caps to close the titanium cannula connectors 9 Plac...

Page 125: ...onnections must be inspected for it s solidity safeness and tightness Do not start pump operation until the blood pump is completely free of air Do not touch or manipulate the blood pump with pointed or sharp edged objects e g surgical instruments Do not touch or manipulate the drive lines with pointed or sharp edged objects surgical instruments wire brushes etc otherwise these components could be...

Page 126: ...rial cannulation 1 left atrium 2 right atrium 3 pulmonary artery 4 aorta 9 1 Cannula exit sites Fig 9 1 Cannula position following implantation 1 Aortic cannula 2 PA cannula 3 RA cannula 4 LV apex cannula Possible exit site for LV apex cannulation depending on the size of the patient s heart Fig 9 2 Suggested cannulae exit sites Example BVAD with LV apex cannulation 1000721x09 Revision 8 116 ...

Page 127: ...a by bending it back and forth Refer to the respective cannula type as described in section 9 3 Cannulae cannula extension set and connecting set page 117 to section 9 7 Arterial cannula e page 126 of the instruction for use to determine the sequence of cannulae anastomosis and tunneling 12 mm 9 mm 6 mm Fig 9 3 Available sizes of cannula tunneling tips 1 1 2 1 2 3 Dressing forceps Cannula tunnelli...

Page 128: ... of the tube part remaining to meet the minimum length recommendations See Tab 9 1 page 120 Do not kink the drivelines Otherwise there might not be sufficient pump output Do not kink the cannulae needlessly Otherwise there might not be sufficient pump output Moreover cannulae might be damaged At least daily the EXCOR cannulae should be inspected for signs of wear or damage ADVICE To avoid needless...

Page 129: ...sual inspection of the titanium connector on the blood pump is no longer possible use the cannula extension set Cannula extension set and connecting set WARNING The cannula extension set and the connecting set should only be used if neccessary since the basic risk of thrombogenesis and deposits increases each time the cannula is extended Do not combine the connecting set with stage cannulae in suc...

Page 130: ...en the cannulae if necessary since they may otherwise be prone to kinking Avoid shortening the cannula too much so as to prevent an overlap of the connector end and velour and to ensure that visual inspection of the cannula and connector respectively is still possible Pay attention also to Tab 9 1 page 120 Preparation INSTRUCTION 1 Take hold of the cannula extension set the connecting set resp 2 I...

Page 131: ...ng a blood pump INSTRUCTION 1 Push the free end of the cannula onto the titanium connector of the cannula extension of the connector resp 2 Flush the tube sections with sterile injectable saline solution 3 Push the sections of tube which are free of air onto the titanium connectors of the blood pump 4 Proceed according to context Act according to 15 1 2 page 196 and 15 1 3 page 197 respectively bu...

Page 132: ... 9 7 page 122 INSTRUCTION 1 If indicated initiate ventricular fibril lation as needed 2 Apical excision of the LV The ideal implant position of the LV cannula is slightly off center of the LV apex toward the lateral wall The dis tance from LAD septum to the cen ter of the excised muscle core is about 2 cm for children see 1 in Fig 9 7 page 122 Fig 9 6 Anastomosis of LV apex cannula 3 We recommend ...

Page 133: ...p at the distal end of the cannula After the cannula has been pulled through the skin cut off and discard the part of the cannula where the clamp was applied If it is necessary to clamp any other part of the cannula that is not covered with velour cover the part of the cannula that will be clamped with a gauze sponge The skin incision must be slightly smaller than the cannula diameter to ensure go...

Page 134: ...e cannula tunneling tip page 117 to advance the cannula through the prepared transcutaneous tunnel If it is necessary to apply a clamp directly to the cannula in order to pull the cannula through the skin the following procedures should be observed Position the clamp at the distal end of the cannula After the cannula has been pulled through the skin cut off and discard the part of the cannula wher...

Page 135: ...rium ADVICE Create the anastomosis laterally directly above the tricuspid valve a closed technique INSTRUCTION 1 Make a running purse string suture with monofilament secured with pledgets at 4 positions 2 Place 4 single U sutures secured with pledgets on each side of the purse string suture 3 Make a sufficiently long incision inside of the suture circle and Fig 9 9 Suture technique right atrium ex...

Page 136: ...ed objects e g surgical instruments Using a pair of forceps firmly grip the flat end piece of the tunneling tip and pull it through the cannula tunnel and the skin incision IMPORTANT Do not rotate the cannula while pulling it through the tunnel The incision must be smaller than the cannula diameter to ensure good ingrowth but large enough to prevent skin necrosis Plan the cannula exit sites approp...

Page 137: ...mp any other part of the cannula that is not cov ered with velour cover the part of the cannula that will be clamped with a gauze sponge Pulmonary artery Fig 9 11 Anastomosis of the aortic cannula INSTRUCTION 1 Make a longitudinal incision of a size suitable for the cannula diame ter in the pulmonary artery 2 Anastomose the cannula using 10 teflon backed double reinforced individual monofilament e...

Page 138: ...required length Make the cut perpendicular to the cannula axis and ensure that the cut is straight 2 Make sure that the lengths of the 2 cannulae leading to the same pump match It must be possible to connect the cannulae to the pump without having to exert any tension 9 9 Connecting the blood pumps to the cannulae WARNING Ensure that cannulae blood pump s and driving tubes are not subject to exter...

Page 139: ...rt of the can nula that will be clamped with a gauze sponge 3 First connect the inflow cannula to the pump then connect the outflow can nula When doing so add sterile injectable saline with a bulb syringe in order to connect the pump air free Be careful to avoid damaging the gloves and the inner cannula lumen and pump surfaces 4 Release the tube clamps de air the pump s and the cannulae 5 Connect ...

Page 140: ...ve the ligature around the de airing nipple see image 2 in Fig 9 14 page 130 2 Pull the de airing needle out of the de airing nipple After the patient has been weaned from the CPB and the proper function of the EXCOR is established the connections of the driving tubes and cannulae to the blood pump s have to be secured 9 11 Securing the connections Fig 9 14 Removing the de airing needle WARNING Al...

Page 141: ...tie gun page 109 Fig 9 15 Cable tie exactly positioned 5 A 2nd cable tie can be used option ally If a 2nd cable tie shall be used 2 it has to be positioned above the 1s t cable tie IMPORTANT the heads of the cable tie straps should both be staggered and directed away from the patient s body 1 2 Fig 9 16 2nd cable tie optional 6 If an EXCOR cannula extension set connecting set is required for impla...

Page 142: ...Chapter 9 Implantation surgical procedure This page was left blank intentionally 1000721x09 Revision 8 132 ...

Page 143: ...NO phosphodiesterase inhibitor prostaglandin etc Auto transfusion equipment e g Cellsaver should be available for use in the operating room For patients with an LVAD start ventilation with nitric oxide or administer the appropriate medication to treat pulmonary hypertension and reduce afterload for right ventricle 15 minutes before weaning from the CPB This can help to prevent or lower the risk of...

Page 144: ...Chapter 10 Implantation anesthesia Any other monitoring processes can be used e g neurological monitoring at the anesthesiologist s discretion 1000721x09 Revision 8 134 ...

Page 145: ...ranscutaneous exit site Do not use any acetone or petroleum based products near the cannulae and the transcutaneous exit site We recommend using chlorhexidine to clean the cannulae and transcutaneous exit site IMPORTANT Do not use any corrosive or colored solutions or organic solvents to clean the cannulae and the transcutaneous exit site as they may alter the surface of the product NOTICE Do not ...

Page 146: ...POD 28 twice a week if the wound is dry and not infected If the wound shows signs of infection clean wound and change dressing twice a day 11 1 Removing the old dressings INSTRUCTION 1 Unpack all the material required to dress the wound and place this within reach on a sterile sheet 2 Put on disposable gloves remove old dressings 3 Take off the disposable gloves put on the sterile gloves 4 Remove ...

Page 147: ...pare sterile dressing tray put on sterile gloves If assistance is necessary notify Berlin Heart 2 4X4 gauze soaked in 2 chlorhexi dine cleanse each cannula exit site in a circular motion outward to a radius of approximately 10 cm 3 Using a new soaked 4X4 repeat 2 more times beginning at the exit site and clean in larger circles each time 4 Wrap 4X4 gauze soaked in 2 chlorhexidine around cannula an...

Page 148: ...to dry com pletely 11 4 The new dressing 11 4 1 Preparing a new dressing Fig 11 6 Cleanse entire cannula INSTRUCTION 1 Apply non sting barrier film to skin around cannulae Non sting barrier prevents skin maceration around cannula exit sites Fig 11 7 Non sting barrier film 11 4 2 Applying a new dressing INSTRUCTION 1 Wrap a Metalline drain compress around each cannula from right to left slit always...

Page 149: ...f the folded compress should point in the direc tion of the wound Pull the cannulae into place by tugging the compress slightly Fig 11 10 Gauze compress under the cannulae 4 Fold the left end of the compress upwards diagonally to the right and secure with a sterile bandage Fig 11 11 Fold the left end of compress and secure 5 Fold the right end of the compress upwards diagonally to the left and sec...

Page 150: ...h sterile gauze compresses 8 Secure the upper part of the dress ing with a sterile bandage Fig 11 15 Secure with a sterile bandage 9 Finally seal the dressing at the left and right side below the cannulae and between the individual cannu lae with strips of adhesive bandage e g Leukoplast Fig 11 16 Seal with strips of adhesive bandage 10 Place tubular bandage i e Burn net around patient 11 Tie in f...

Page 151: ... of several pump cycles If a pump is not filling and or ejecting completely then take the appropriate corrective action 11 5 1 Visual inspection pump filling and ejection The filling and ejection behavior of a blood pump is optimal when the membrane surface is completely smooth at the end of systole and end of diastole positions Check visually that the pump s is are filling and ejecting completely...

Page 152: ...the cursor to the desired field in the parame ter table The selected field is given a colored background 2 Use the and Bild Bild keys to adjust the value then press Enter to confirm the input The system will now operate using the new set tings Cautionary measure Confirm each changed parameter value by pressing Enter The system does not take over the new changed value until it has been confirmed wi...

Page 153: ...g the visual check first clean the blood pump then illuminate the blood chamber with a flashlight This makes it easier to detect deposits Enter all of the findings into the blood pump log see section 16 6 Sample copy EXCOR pump log page 227 Cautionary measures Initial signs of deposits check anticoagulation therapy and adjust therapy if necessary Floating deposits inside the pump replace the pump ...

Page 154: ... Growth and or weight gain can result in the patient not receiving adequate support Use the chart in section 16 1 2 Overview Relationship body weight pump size page 211 to plan in good time which pump s the patient may need to change over to This chart is for guideline purposes only and is not binding for each individual case This decision must be taken by the surgeon in consultation with Berlin H...

Page 155: ...mended 12 2 During Implantation Cardiopulmonary Bypass 12 2 1 Cardiopulmonary Bypass CPB Use unfractionated heparin as per institutional protocol for cardiopulmonary bypass 12 2 2 Post CPB Completely reverse heparin with protamine sulphate as per institutional protocol The goal post CPB is to achieve normal institution specific coagulation parameters INR PTT fibrinogen platelet count In the early ...

Page 156: ...or Xa levels If anti Xa levels do not correlate with the PTT in this setting consider using the PTT to monitor heparin therapy Antithrombin should be 70 If the antithrombin is 70 treat according to institutional protocol 12 3 4 Unfractionated heparin therapy i v Patient 12 months Initial dose 10 IU kg hour Do not use a bolus After 6 hours if the patient does not have increased bleeding increase th...

Page 157: ...ry 12 hours Patient 1 5 years start administration of Enoxaparin at 1 2 mg kg subcutaneously every 12 hours Patient 5 16 years start administration of Enoxaparin at 1 1 mg kg subcutaneously every 12 hours Stop heparin infusion and administer LMWH subcutaneously simultaneously Obtain the first anti factor Xa level at 4 hours after the 2nd LMWH dose is administered See Tab 12 2 page 150 for monitori...

Page 158: ... TEG Antithrombin WBC HgB HCT BUN SCr AST ALT bilirubin T D prealbumin CRP While on UFH obtain anti factor Xa level daily While on enoxaparin obtain anti factor Xa daily until in therapeutic range and on a stable dose then twice a week for two weeks and then weekly If infection is suspected appropriate measures must be taken immediately antibiotic therapy adjustment of the anticoagulation and plat...

Page 159: ... often elevated above normal Accordingly the physician may choose to administer the following medications at his her discretion to facilitate the overall anticoagulation anti platelet management of the patient Omega 3 fatty acids e g DHA EPA have been shown to have an anti inflammatory effect and also decrease premature activation of platelet membrane Omega 3 fatty acids are composed of long chain...

Page 160: ...6 120 30 min 10 4h 0 90 120 60 min 15 4h Tab 12 1 Unfractionated Heparin adjusted to maintain an anti factor Xa level of 0 35 to 0 50 U ml Anti Factor Xa level U ml Hold Next Dose Dose Change Repeat Anti Factor Xa 0 35 no increase dose by 25 4 h after next dose 0 36 0 45 no increase dose by 15 4 h after next dose 0 46 0 59 no increase dose by 10 4 h after next dose 0 6 1 0 no no 4 h after next dos...

Page 161: ...1 1 3 repeat day 1 loading dose 1 4 1 9 50 of day 1 loading dose 2 0 3 0 50 of day 1 loading dose 3 1 3 5 25 of day 1 loading dose 3 5 hold dosing until INR is 3 5 Tab 12 3 Warfarin loading dose to maintain an INR of 2 7 3 5 Monagle P et al Stage INR Action Maintenance Day 5 and long term 1 1 1 9 increase dose by 40 50 2 0 2 4 increase dose by 10 2 7 3 5 no change 3 6 4 0 administer next dose at 5...

Page 162: ...Chapter 12 Anticoagulation therapy This page was left blank intentionally 1000721x09 Revision 8 152 ...

Page 163: ...hallenge It is not recommended that weaning proceed unless all parameters especially those pertaining to anti coagulation have been fully optimized This protocol reflects the most recent understanding of the safest possible weaning strategy based on the collective US and European experience to date Consultation with Berlin Heart Inc prior to weaning and explantation is strongly recommended 13 1 2 ...

Page 164: ... with invasive hemodynamic assessment with afterload challenge Day 6 Pump stoppage with invasive hemodynamic assessment in OR full anticoagulation This size based weaning protocol accounts for physiologic differences in heart rate and stroke volume observed in children of varying ages 13 1 5 10 ml 15 ml pump The individual weaning progress is based upon the following parameters Parameter Explanati...

Page 165: ... max 5000 units 2 After 5 minutes reduce the pump rate step wise from IR _____ bpm to 30 bpm in increments of 5 bpm q5 min After 5 minutes at 30 bpm reassess LV size and function 3 After an additional 5 minutes i e total time 10 min at 30 bpm stop the pump for 3 min and reassess LV size and function During pump stoppage use the manual pump to pump twice q30 seconds to minimize the risk of thrombus...

Page 166: ...nt satisfy all 5 eligibility criteria throughout the period of weaning and pump stoppage ÿNO STOP ÿYES Proceed MD________ Day 2 After confirmation of eligibility criteria the following steps should be performed under echo guidance 1 1 Administer UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce the pump rate step wise from RR1 _____ bpm to 30 bpm in increments of 5...

Page 167: ...pump stoppage ÿNO STOP ÿYES Proceed MD________ Day 4 After confirmation of eligibility criteria the following steps should be performed under echo guidance 1 1 Administer UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce pump rate step wise from RR3 ___ bpm to 30 bpm in increments of 5 bpm q 5 min After 5 minutes at 30 bpm reassess LV size and function 3 Initiate e...

Page 168: ... manually twice q30 seconds 6 If LV size and function acceptable proceed pumping manually twice q30 seconds for 3 min While doing so reassess LV size function and record RAP PAP PCWP and MVS 7 After 6 minute pump stop If the patient meets all eligibility criteria reconnect pump to Ikus and resume pumping at 50 bpm until the actual surgical procedure of explantation takes place If the patient does ...

Page 169: ...ility criteria the following steps should be performed under echo guidance 1 1 Administer unfractionated heparin UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce the pump rate step wise from IR _____ bpm to 30 bpm in increments of 5 bpm q5 min After 5 minutes at 30 bpm reassess LV size and function 3 After an additional 5 minutes i e total time 10 min at 30 bpm st...

Page 170: ...t satisfy all 5 eligibility criteria throughout the period of weaning and pump stoppage ÿNO STOP ÿYES Proceed MD________ Day 2 After confirmation of eligibility criteria the following steps should be performed under echo guidance 1 1 Administer UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce the pump rate step wise from RR1 _____ bpm to 30 bpm in increments of 5 ...

Page 171: ... pump stoppage ÿNO STOP ÿYES Proceed MD________ Day 4 After confirmation of eligibility criteria the following steps should be performed under echo guidance 1 1 Administer UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce pump rate step wise from RR3 ___ bpm to 30 bpm in increments of 5 bpm q 5 min After 5 minutes at 30 bpm reassess LV size and function 3 Initiate ...

Page 172: ...lly twice q30 seconds 6 If LV size and function acceptable proceed pumping manually twice q30 seconds for 5 min While doing so reassess LV size function and record RAP PAP PCWP and MVS 7 After 20 minute pump stop If the patient meets all eligibility criteria reconnect pump to Ikus and resume pumping at 50 bpm until the actual surgical procedure of explantation takes place If the patient does not m...

Page 173: ...ibility criteria the following steps should be performed under echo guidance 1 1 Administer unfractionated heparin UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce the pump rate step wise from IR _____ bpm to 30 bpm in increments of 5 bpm q5 min After 5 minutes at 30 bpm reassess LV size and function 3 After an additional 5 minutes i e total time 10 min at 30 bpm ...

Page 174: ...nt satisfy all 5 eligibility criteria throughout the period of weaning and pump stoppage ÿNO STOP ÿYES Proceed MD________ Day 2 After confirmation of eligibility criteria the following steps should be performed under echo guidance 1 1 Administer UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce the pump rate step wise from RR1 _____ bpm to 30 bpm in increments of 5...

Page 175: ... pump stoppage ÿNO STOP ÿYES Proceed MD________ Day 4 After confirmation of eligibility criteria the following steps should be performed under echo guidance 1 1 Administer UFH 75 units kg x _____ kg _____ mg IV x 1 max 5000 units 2 After 5 minutes reduce pump rate step wise from RR3 ___ bpm to 30 bpm in increments of 5 bpm q 5 min After 5 minutes at 30 bpm reassess LV size and function 3 Initiate ...

Page 176: ...twice q30 seconds for 15 min While doing so reassess LV size function and record RAP PAP PCWP and MVS 7 After 30 minute pump stop If the patient meets all eligibility criteria reconnect pump to Ikus and resume pumping at 50 bpm until the actual surgical procedure of explantation takes place If the patient does not meet all criteria reconnect Ikus and resume pumping at IR Did the patient satisfy al...

Page 177: ...nulae were placed 13 2 2 Explantation after biventricular support Stopping the right pump INSTRUCTION 1 Select Pause right see Fig 13 1 page 167 then press Enter to confirm Respond to the prompt in the dialog window by pressing the X key or the 1 key The right pump will stop The view Pump size and single step mode is shown see Fig 7 7 page 100 The cursor is located on the OK field 2 Unplug the dri...

Page 178: ...be connector sockets 8 Wait until the log has been completed When the message Switch drive off with main switch appears press F10 to shut down the monitor program Confirm by pressing the X key or the 1 key 9 Select 3 End 3 see Fig 13 3 page 169 in the start menu and switch off the laptop 10 Switch the Ikus off provided that the batteries are fully charged To do so turn the key switch to 0 position...

Page 179: ...F option and press Enter to confirm see Fig 13 2 page 169 5 Respond to the prompt in the dialog window by pressing the X key or the 1 key The system stops operation immediately and writes an operating log 6 Disconnect the driving tube s from the connector s To do so take hold of the release sleeve and pull this out of the connector 7 Use the seal plugs to seal the driving tube connectors 8 Wait un...

Page 180: ...D cannulae INSTRUCTION 1 Clamp off the cannulae 2 Disconnect the pump from the cannulae 3 Remove the cannulae Sew over the anastomosis areas of the atrium The remaining procedure is the same as for any primary orthotopic heart transplantation 1000721x09 Revision 8 170 ...

Page 181: ... and then take appropriate action When an error message occurs the following happens An acoustic signal 2 different beep sounds is emitted The indicator light on the control panel of the handle lights up A red border is shown around the field Alarm off in the monitor program display In the message window of the monitor program a text is displayed informing about the time of occurrence the type of ...

Page 182: ...blue connector system 3 backup backup system All messages together with their time of occurrence are recorded in the log file In the case of some messages the cause of the fault may correct itself automatically after a short time In this case a corresponding message is shown e g Please check left driving tube and pump or Left driving tube pump OK INSTRUCTION 1 Press the mute button on the control ...

Page 183: ...t page 176 together with a request to inform the service department HOTLINE Notify Berlin Heart 866 249 0128 If the Ikus has detected an external fault it displays the message Please connect driving tube see section 14 3 Please connect driving tube page 174 Provide the patient immediately with a replacement Ikus If the main computer and the backup computer arrive at different results in the test p...

Page 184: ...red log into the monitor program by entering user ID and password and confirm with Enter 2 Select the option Drive pause and press Enter to confirm Respond to the prompt in the dialog window by pressing the X key or the 1 key The Ikus will stop 3 Carefully cut the cable tie on the defective driving tube 4 As soon as the pump has stopped remove the defective driving tube from the pump 5 Connect the...

Page 185: ...60 bpm without constant supervision IMPORTANT First mute the message on the drive unit do not acknowledge yet in the monitor program Otherwise alarms will occur by mistake When muted the alarm will be audible again in an 1 minute interval INSTRUCTION 1 Mute the message on the drive unit 2 Inspect the driving tube and the cannulae are kinks blocking the flow Correct the positions to ensure an unimp...

Page 186: ...mer service Backup operation left Contact costumer service The left or right pneumatic system has failed The respective pump is now being powered by the backup system INSTRUCTION 1 Provide the patient immediately with a replacement Ikus HOTLINE Notify Berlin Heart 866 249 0128 14 6 Error messages in emergency operating mode 14 6 1 UVAD emergency operation Contact service immediately UVAD emergency...

Page 187: ...s have developed faults The Ikus driving unit has been running on battery power for too long Error message Emergency operation due to empty batteries Risk of total failure It was no longer possible to establish reliable conditions In order to ensure that this is not due to a control circuit defect the Ikus has switched over to the backup system and the backup control computer The message Backup co...

Page 188: ...thout supervision A fault in the alarm circuit is discovered during the self test for the alarm circuit or when an alarm situation occurs Depending on the type of fault the message appears Alarm circuit test failed buzzer remains off Alarm circuit test failed buzzer remains on Acoustic alarm is not properly recognized INSTRUCTION 1 Provide the patient immediately with a replacement Ikus HOTLINE No...

Page 189: ... the message appears again INSTRUCTION 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 Provide the patient immediately with a replacement Ikus and switch off the malfunctioning Ikus see section 15 4 Connecting the patient to a replace ment Ikus page 202 If no replacement Ikus i...

Page 190: ...pump being driven by the tested system stops for approx 10 seconds during the test phase INSTRUCTION 1 Check the status of the patient 2 If the Ikus switches to backup operating mode or this message repeatedly appears inform Service immediately 3 Provide the patient immediately with a replacement Ikus See section 15 4 Connecting the patient to a replacement Ikus page 202 HOTLINE Notify Berlin Hear...

Page 191: ...ther liquids to cool the Ikus Otherwise there is a risk of short circuit and or device malfunction IMPORTANT An alarm was triggered by one of the sensors and an user muted it mute interval 10 min During this mute interval now another sensor generates another alarm which is also muted by the user This means that the remaining mute time of the first triggered alarm will be extended for another full ...

Page 192: ...ot possible ABORT Batteries discharged No Battery operation possible The batteries have become discharged during mains operation by a battery malfunction WARNING Continue to operate the Ikus on mains There is a risk of total malfunction if battery operation is used INSTRUCTION 1 Check the status of the patient 2 Check the filling and emptying of the blood pump s and monitor the function of the Iku...

Page 193: ... appears 14 18 Error messages Circuit breaker and internal battery fuse DANGER Battery fuse test failed Check circuit breaker No battery mode possible Contact service DANGER Internal battery fuse test failed No battery mode possible Contact service The following applies to both error messages WARNING Ikus must be kept connected to the power supply Danger of total shutdown in battery mode INSTRUCTI...

Page 194: ...t appear within 8 seconds the alarm circuit is defective A possible error might not have been detected INSTRUCTION 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 Provide the patient immediately with a replacement Ikus and switch off the malfunctioning Ikus see section 15 4 Con...

Page 195: ...od pump s with the manual pump page 204 HOTLINE Notify Berlin Heart 866 249 0128 14 22 Left right flow sensor defective Notify Service Left flow sensor fault Contact customer service Right flow sensor fault Contact customer service The corresponding flow sensor is defective Although the Ikus continues to run the excessively low flow would not be detected possibly due to a kink in a cannula or the ...

Page 196: ...ithout supervision 3 Provide the patient immediately with a replacement Ikus and switch off the malfunctioning Ikus see section 15 4 Connecting the patient to a replace ment Ikus page 202 If no replacement Ikus is available Support the patient if necessary in the event of malfunction of the defective Ikus by means of the manual pump see section 15 5 Driving blood pump s with the manual pump page 2...

Page 197: ...tery problem The charge level of the batteries is too low to permit battery operation INSTRUCTION 1 Operate the Ikus on mains Battery operation is only possible if all of the yellow LEDs are illuminated 14 25 2Additional messages during the start up test If the Ikus detects an error during the start up test one of the following messages appears in the message window depending on the nature of the ...

Page 198: ...em 1 left Discrepancy in pressure measurement system 1 right Discrepancy in pressure measurement system 1 backup This message is only an information message INSTRUCTION 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 Compare nominal values with the values actually generated In ...

Page 199: ... perform a test phase which means that the blood pump of the corresponding system is briefly stopped for the duration of this test The information message Discrepancy in pressure measurement system 1 2 or 3 is not accompanied by an acoustic signal HOTLINE Notify Berlin Heart 866 249 0128 14 27 Communication with Laptop failed This message informs the user that the communication between the control...

Page 200: ...Chapter 14 Error Messages and corrective measures This page was left blank intentionally 1000721x09 Revision 8 190 ...

Page 201: ...ttempting to section 14 4 Please check left right pump and driving provide diastolic or tube page 175 systolic pressure Check for clots in the pump or cannula that may be obstructing flow and replace the pump if necessary see section 15 1 Replacing the blood pump s page 195 Initiate hand pumping to try to eject the pump see section 15 5 Driving blood pump s with the manual pump page 204 Switch the...

Page 202: ...frequently for proper area around the blood pump function Clear fluid content if any in the drive stabilization ring of line and air chamber of the pump the blood pump Check if the condensate will leave in the next days Contact Berlin Heart Flapping or Possible cause fluttering of membrane during membrane movement of the Partial rupture of one or two layers of the triple layer membrane Changes in ...

Page 203: ... The driving tube has been damaged and the integrity of the tubing may be compromised There may or may not be an audible sound from air escaping the tubing This condition may be accompanied by the following error messages section 14 1 Pressure error time error in system 1 or in system 2 or 3 page 173 followed by section 14 3 Please connect driving tube page 174 What to do If the driving tube is de...

Page 204: ...sulting the service department staff See section 15 2 Restarting Ikus page 198 Acoustic and visual Possible causes alarm from the Ikus message Error no data from Master simultaneous malfunction of both control computers or Error no power supply malfunction reaction from What to do Master Assess the condition of the patient and the hemodynamic values Notify Berlin Heart immediately Pump stands stil...

Page 205: ...ere is the risk of pulmonary edema When connecting the blood pump s pay attention to the direction of the arrows on the inflow and outflow stubs These show the direction of the blood flow NOTICE If the replacement pump has a larger volume than the one being replaced the use of a connector set must be considered the corresponding parameter in the view Pump size and single step mode must be updated ...

Page 206: ...xample a scalpel or scissors to remove the cable tie This may cause damage to the cannula Check cannulae immediately to make sure they are not damaged 3 If necessary log into the monitor program by entering user ID and password confirming the password with Enter 4 BVAD Reduce rate of left blood pump to 30 bpm Use to navigate cursor to the respective field of the parameter table then use to adapt v...

Page 207: ... Enter to confirm The driving unit starts up again using the defined parameters 5 Check whether the pump is filling correctly and if necessary adjust the parameters 6 Secure all connections with cable ties See section 9 11 Securing the connec tions page 130 15 1 3 Replacing the left blood pump LVAD BVAD WARNING BVAD If the left pump is being replaced the right pump must also be stopped while the p...

Page 208: ...d pump to the Ikus INSTRUCTION 1 Fill the free ends of the cannulae with sterile saline solution Make sure that all air has been removed Connect the prepared replacement pump to the cannu lae 2 Plug the new driving tube into the freed connector The plug snaps into place clearly audible 3 Check that the plug is securely connected To do so grip the plug body above the release sleeve and pull on it D...

Page 209: ... emergency pulse mode In this case proceed as explained in section 15 3 Emergency pulse mode page 200 4 Wait until the log has been completed If the message Switch off drive with main switch appears turn the key switch to the 0 position 5 Switch off the laptop 6 Switch Ikus on again immediately To do so turn the key switch to the I posi tion 7 Switch the laptop on Select the 1 Start program option...

Page 210: ...5 5 Driving blood pump s with the manual pump page 204 Otherwise there is the risk that the patient will not be supported sufficiently IMPORTANT In emergency pulse mode a controlled shut down is not possible IMPORTANT In emergency pulse mode it is not possible to acknowledge the acoustic alarm If the graphs in the monitor program are not moving and the parameters cannot be adjusted even after the ...

Page 211: ... in emergency pulse mode Otherwise only the service staff will be able to restart it Never connect other USB devices e g wireless technology to the USB port of the laptop than the delivered USB sticks INSTRUCTION 1 After 5 minutes Insert the USB stick into the USB port and switch on the Ikus To do so turn the key switch to the I position The battery charge indica tor will light up and the number o...

Page 212: ...hen it is switched on This is the only way to ensure that the start up test is performed completely and possible malfunctions can be detected This is necessary if maintenance is required the Ikus is defective Ikus and all of its parts shall not be serviced or maintained while in use with a patient Switching the replacement Ikus on INSTRUCTION 1 Prepare the replacement Ikus and connect it to the ma...

Page 213: ...The Ikus checks whether the driving tube connector with the blue marking has been sealed Then the view Pump size and single step mode is displayed 6 Transfer all the parameters from the original Ikus to the replacement Ikus 7 Move cursor to the field Step left and press Enter to confirm Biventricular Move cursor to the field Step right and press Enter to con firm 8 Move the cursor to the OK field ...

Page 214: ... settings 6 Check whether the pump is filling correctly and if necessary adjust the parameters 7 Switch off the original Ikus see section 6 3 3 Drive OFF switching the Ikus off page 78 15 5 Driving blood pump s with the manual pump Fig 15 1 Patient on manual pump This is necessary if the power supply to the Ikus cannot be ensured the Ikus has to be restarted e g emergency operating mode and there ...

Page 215: ...ent is lying down 2 Disconnect the driving tube s from the Ikus To do so take hold of the release sleeve and pull this out of the connector 3 Connect the driving tube s to the manual pump IMPORTANT Observe the colored markings 4 Check that the plug is securely connected To do so grip the plug body above the release sleeve and pull on it see 4 in Fig 15 3 page 206 Do not pull from the release sleev...

Page 216: ...e patient 2 Check the filling and ejection behavior of the blood pump s 3 If possible ensure support of patient with a replacement Ikus and switch off the faulty Ikus see section 15 4 Connecting the patient to a replacement Ikus page 202 If both control computers fail at the same time or if there is a mains failure the Ikus cannot generate any specific error messages in the message window An acous...

Page 217: ...n transferred onto a USB stick INSTRUCTION 1 Press F10 to exit the monitor program and confirm the intention in the dia log window by pressing the X key or the 1 key The start menu is dis played The Ikus will continue to operate using the current parameter settings 2 Switch off the laptop Insert the USB stick into the port never do this while the laptop is switched on Switch on the laptop again 3 ...

Page 218: ... to stop immediately INSTRUCTION 1 Ensure that the Ikus is connected to the mains 2 Check if the circuit breaker was triggered Push the button Circuit breaker back in place to produce power supply again Important Only press the button briefly Never keep the button pressed for a longer period because otherwise the retriggering of the circuit breaker would not be detected 3 If the circuit breaker is...

Page 219: ...s triggered If yes immediately push it back in place Start the Ikus again just in case that it does not not happen automatically 2 If the circuit breaker is triggered again immediately ensure the support of the patient with the manual pump HOTLINE Notify Berlin Heart 866 249 0128 1000721x09 Revision 8 209 ...

Page 220: ...Chapter 15 Troubleshooting and correcting faults This page was left blank intentionally 1000721x09 Revision 8 210 ...

Page 221: ...ab 16 1 Blood pumps PU valves 16 1 2 Overview Relationship body weight pump size Fig 16 1 Relationship body weight pump size The final decision of pump selection should be made by the implanting physician based on the individual patients needs and the weight pump output guidance represented in this graph Note that the graph represents common clinical use and not the maximum technical performance o...

Page 222: ...th of head mm Angle of head C15V 040 5 200 15 80 C19V 020 6 250 19 80 C22V 004 9 121 280 240 22 45 C25V 004 9 121 280 240 25 45 C22V 002 12 330 22 45 C26V 002 12 330 26 45 1 with without stage cut off Tab 16 3 Atrial cannulae 16 1 5 Arterial cannulae Article number mm Overall length mm Length of head mm Angle of head Remarks C80G 040 5 200 4 5 80 C80G 021 6 250 5 80 C60G 004 12 91 280 2401 0 60 wi...

Page 223: ... Overall length mm Length of head mm Angle of head Remarks C60G 002 12 330 0 60 with flexible reinforcement C85G 002 12 330 0 85 with flexible reinforcement 1 with without stage cut off Tab 16 4 Arterial cannulae 1000721x09 Revision 8 213 ...

Page 224: ...AP SC P25P 001x01 9 6 C19V 020 AT CS C80G 021 CS P30P 001x01 6 C18A 020 AP CS 9 C22V 004 AT SC C60G 004 9 C25V 004 AT SC C85G 004 SC 9 C22A 004 AP SC P50P 001 12 12 C22V 004 AT SO C60G 004 SO CS P60P 001 12 C25V 004 AT SO C85G 004 SO CS 12 C22V 002 AT C60G 002 12 C26V 002 AT C85G 002 12 C22A 004 AP SO 12 C27A 001 AP Explanation AT atrial cannula AP apex cannula SO staged stepped diameter cannula o...

Page 225: ...h 200 cm Tab 16 6 System Accessories 16 1 8 Driving unit Article number Designation D03I 111 EXCOR Stationary Driving Unit Ikus 115V 60Hz SW 3 41 Tab 16 7 Driving unit 16 1 9 Special components Article number Designation A06 006 Cannula extension set 6 6 mm A09 009 Cannula extension set 9 9 mm A12 012 Cannula extension set 12 12 mm A06 009 Connecting set for cannulae 6 9 mm A09 012 Connecting set ...

Page 226: ...he blood pump The value indicated is the upper threshold for pump rates Values that are below the upper threshold are within the rate value acceptable range Values that are higher than the upper bpm threshold are in a questionable range The threshold values have been determinated in vitro tak ing a mean arterial blood pressure of 120 mmHg as a basis Red marked values displayed on the laptop These ...

Page 227: ...12Relative systolic duration The relative systolic duration is adjustable in the range of 20 and 70 The upper and lower threshold 20 30 and 60 70 are marked in red on the laptop For these values it cannot be guaranteed that the activated pressure parameters are achievable for each single case 16 2 Technical specifications Electro pneumatic extracorporeal ventricular assist device EXCOR Pediatric V...

Page 228: ... CBAS Max period of use max 1 year Cannulae Dimensions Refer to product data sheets Material Silicone partially reinforced with plastic webbing partially encased with suture suitable polyester velour some equipped with flexible metal reinforcement wire 2 mm circular steel Rd 1 4301 apex cannula with a titanium alloy shell For all sterile products Long term storage conditions Temperature 15 C to 25...

Page 229: ...500 V Protection class IPX1 protection against touching live parts not tested tested safety from vertically dripping water Pump rate 30 to 150 bpm Sound level of acoustic alarm 71 dB A Systolic pressure 60 to 350 mmHg Diastolic pressure 100 to 0 mmHg Pressure display accuracy 10 Relative systolic duration 20 to 70 Off mains operating time max 30 minutes Battery charging time 6 h Maintenance interv...

Page 230: ...aging unsafe Batch code Keep dry Serial number WEEE symbol not to be dis posed of with consumer waste Manufacturer Can be disposed of with con sumer waste Date of manufacture Use by date Sterilized using ethylene oxide Do not use if package is damaged Do not re use Do not resterilize Humidity limitation Temperature limit Fig 16 2 Symbols used on labeling For symbols on the connection panel See sec...

Page 231: ...Chapter 16 Appendix 16 4 Sample copy Ikus Incoming Checklist 1000721x09 Revision 8 221 ...

Page 232: ...Chapter 16 Appendix 16 5 Implantation record form 1000721x09 Revision 8 222 ...

Page 233: ...Chapter 16 Appendix 1000721x09 Revision 8 223 ...

Page 234: ...Chapter 16 Appendix 1000721x09 Revision 8 224 ...

Page 235: ...Chapter 16 Appendix 1000721x09 Revision 8 225 ...

Page 236: ...Chapter 16 Appendix 1000721x09 Revision 8 226 ...

Page 237: ...utflow stub in front of outflow valve 9 transition outflow connector outflow cannula 10 outflow valve 11 outflow stub behind outflow valve Fig 16 3 EXCOR blood pump with checkpoint numbers ADVICE To briefly describe the findings use the following letter codes p small punctual deposit f small strand P large punctual deposit F large strand a small area of deposit t small thrombus A large area of dep...

Page 238: ... deposits 1 small laminar deposit 2 small suture on the inflow valve 3 small specks 4 larger laminar deposit Fig 16 4 Plotting of the deposits Example Notation with letter code Fig 16 5 Example Notation with letter code 1000721x09 Revision 8 228 ...

Page 239: ...Chapter 16 Appendix 1000721x09 Revision 8 229 ...

Page 240: ...Chapter 16 Appendix 16 7 Pump performance flow sheet 1000721x09 Revision 8 230 ...

Page 241: ...s The Ikus is intended for use in the electromagnetic environment specified below The customer or the user of the Ikus should ensure that Ikus is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Ikus uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interf...

Page 242: ... dip in UT should be that of a interruptions for 0 5 cycle for 0 5 cycle typical commercial or and voltage variations on power supply input lines 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles hospital environment If the user of the Ikus requires continued operation during power IEC 61000 4 11 70 UT 30 dip in UT 70 UT 30 dip in UT mains interruptions it is recommended that the for...

Page 243: ...Vrms 150 kHz to 80 10 V d 1 2 P MHz in ISM bandsa Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 5 GHz 30 V m 80 MHz to 6 GHz d 0 4 P 80 MHz to 800 MHz d 0 77 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m b Field strengths from fixed RF transmitters as de...

Page 244: ...from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Ikus...

Page 245: ...tance depending on frequency of transmitter NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher fre quency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz 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 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 has been incorporated into the formulae u...

Page 246: ...Chapter 17 EMC tables This page was left blank intentionally 1000721x09 Revision 8 236 ...

Page 247: ...COR Pediatric 54 operation period 4 22 preparing a replacement 195 regular checks of 141 replacing 195 rinse and fill the 113 stopping 77 stopping an individual 78 univentricular operation 62 blood pump s driving a with the manual pump 204 BVAD anastomosis of the cannulae 116 BVAD see biventricular C Cannula extension set 118 cannulae cautionary measures cannula tunneling tip 117 available sizes o...

Page 248: ...ionary Driving Unit Ikus 57 device description 21 instructions for use 67 moving the 84 product life time 219 recommended separation distances 234 implantation anesthesia 133 infection 135 risk of 135 to prevent 9 inspection filling behavior of blood pump 141 frequency of of pump areas which come in contact with blood 141 143 visual deposits 142 instruction and care of the patient 20 interaction w...

Page 249: ...therapy 17 18 replacing blood pump 195 restart Ikus in emergency operation mode 198 S safety risks 20 selecting pump size s and cannula sizes 75 self test of the alarm circuit 72 separate mode biventricular operating mode 74 single step mode figure 102 removing air from the blood pump s in 102 SRS_691 118 standard default parameters 95 start up test error messages during 83 following emergency ope...

Page 250: ...antation after support 167 redundant design of pneumatic systems 63 V valves control 57 three leaflet polyurethane 21 visual inspection deposits 142 filling and ejecting of the blood pump 14 filling behavior of blood pump 141 regular of blood pumps and cannulae 141 W wound care 135 and treatment 135 X X rays 18 1000721x09 Revision 8 240 ...

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