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"取扱説明書"

Contents

1. 1 BSA 0 7 m2 24 mp 27 5 0 174 87 59
2. 1 3
3. 0 Nt
4. lt 1 BSA 0 7 24 mm 27 5 0 174 87 5x
5. 0 10 11
6. 1
7. Ikus 13 1 Pressure error time error in system 1 or in system 2 or 3 13 1 1 2 3 The blood pump of the corresponding
8. When positioning the driving tubes follow hospita policies to mitigatethe risk of adverse tubing and line incidents by routing he drivingtubes in a clear pattern toward the feet and to the side Do not initiate cardiac support with the EXCOR blood pumps until theblood pumps have been completely de aired After connecting thecannulae
9. 2 A MS
10. 2 CT NA NN EA 5 6
11. 5 EXCOR Pediatric 1kus
12. 415 clean 1 The Ikus power switch toggle switch must always be in the positioneven if the Ikus is set to 0 position at the main switch key switch Ikuns 0 Nn s The Ikus is designed for stationary operation and to be run on mains Do not run it on battery ope
13. 6 Commissioning the Ikus and setting parameters 6 Ikus When operating the manual pump with 1 hand do not block the valveswith your feet see c in figure 14 3 and in fig 14 4 page 144 44 14 3 14 4 c If the user exits the monitor program it is not possible to identify anyincoming messages For this reason aays start the monitor programagain immediately after saving the data
14. program Dage 67 is completed andthat possible malfunctions are detected to the Ikus Ikus AE Place the Ikus driving unit on a firm and Ikus even Surface Never place other objects on top of an Ikus Ikus driving unit kus When switching on the 1kus always connect it to he mains powersupply This is the only way to ensure that the start test SS 2 0 BA
15. 451 Ikus gt KISS
16. Do not kink the drivelines Otherwise there might not be sufficientpump outDut Do not kink the cannulae needlessly Otherwise there might not besufficient pump output Moreover cannulae might be damaged At least daily the EXCOR cannulae should be inspected for signs ofwear or damage ADVI
17. 1 W amp ms gm gt a mw PU w mw mn 2 387 gt 4 1 PIGP 001 10ml 46 m 6 m P15P 001 P
18. cannula while pulling it through the tunnel The incision must be smaller than the Plan the cannula exit sites appropriately Leave an adequate bridge ofSkin and subcutaneouS tissue between the cannula exit incisions to preventbreakdown and necrosis of the skin and tissue If nossible the cannulaexit in sic ions should be on different planes see fig 8 2 page 84
19. 401 clean If there are several electrical devices in the vicinity of the patient thenthese are to be connected to a central grounding point The connectorPotential equalization is to be used for this on the Ikus Otherwise thereis a risk of electric shock Ikus Switch on the 1kus 2 hours before use in order to sufficiently charge thebatteries amd to detect possible device errors during the start test hnportant During this time always connect both tank units to the kus see secti
20. lt gt
21. The air vents must not be covered or obstructed during operation Otherwise the Ikus will not receive sufficient ventilation which may leadto overheating This may lead to malfunctions and a malfunction indevice operation Ikus Only disconnect the Ikus from the mains if the charge level indicatorshows that the batteries are completely charged all yellow LEDs arelit Important Im order to prevent rapid and premature ageing of thebatteries the Ikus must always be run
22. clean the cannulae andtranscutaneous exit site IMPORTANT Do not use any corrosive or colored solutions or organicsolvents to clean the cannulae and transcutaneous exit site as they mayalter AS 0 the surface of the product 1 1 10 Maintenance 1 1 10 If the 1kus is not in operation it requires Tkus Re Ne maintenance every 6 months If it is in operation it requires maintenance after 2 000 0
23. An EXCOR blood pump may not be used onapatient for more than lyear Afterthis it shall be replaced with new products EXCOR 1 1 1 2 7 Battery replacement and disposal 2 7 If the batteries are discharged completejy red LED lights up there is adanger of a total malfunction of the Tkus if battery operation is continued and that the batteries will be damaged If this happens LED Ikus
24. 2 2
25. 2 1 1 2 3 4 5 2 Ikus IABP PCPS
26. 13 6 Error messages in emergency operating mode 13 6 No more system is available as a redundancy If the only remainingintact pueumatic system fails there is a risk that the Ikus will stoprunning altogether Ikus 13 6 2 Emergency operation system 1 or system 2 or 3 Contact Service now There is no longer a redundant backup system If the only remainingintact system fails there is a risk that the Ikus will stop runningaltogether 13 9 Alarm circuit fault buzzer remains off or on 13 6 2 1
27. s An EXCOR blood pump may not be used it shall be replaced with new products on a patient for more than lyear After this EXCOR 1 1 1 1 1 1 1 1 2 Transport within the clinic 1 1 2 To move the Ikus unit push only using the handle provided for thispurpose Avoid any sudden jerky motion When passing over smallerobstructions exercise extreme caution pulling the Ikus unit backwards i e handle first across the obstruction if necessary To lift the kus use only the lifting bars at the lower edge at each side ofthe unit to hold and lift it Never attempt to lift the Jkus by its handie The Ikus must always be lifted by at least
28. 1 BSA 0 7W 24 27 5 0 174g 87 5x gt ELSo 5 20 5B 75w 2 BSA 0 7 1 5 24 42 5 3 192 91 7 ELS 4 7B 27 5 i 66 7 SA 0 068 B 1 1 411 Sg 96 2
29. 2 1 LAD 2 cm 3 LAD 5 6 3 0 4 0 12 16
30. 14 3 1 Emergency pulse mode switching the Ikus off 14 3 1 Ikus 487 T clean The operator is also responsible for adherence to the prescribedmaintenance and service intervals see section 1 2 4 Batteryreplacement and disposal page 27 P 27 1 2 4 A replacement Ikus and replacement equipment must always beavailable in the hospital Ikus 14 3 2 Ikus start test following emergency pulse mode Ikus
31. BEnter Pump output measurement activated 6 gt gt 453 3 2 63 1 1 a EXCOR Pediatric
32. 1 1 EXCOR 4 Under certain circumstances the message left right pump is not fillingadequately in some circumstances is ot generated with the 10 mlEXCOR blood pump d
33. 1 Do not touch or manipulate the blood monofilament not traumatizing material 8 3 Cannulae and connector set During implantation the Cannula Tunneling Tip provided with eachcannula should be used during implantation of the EXCOR system 8 3 EXCOR pump with pointed or sharpedgedobjects e g surgical instruments Ifa cannula is bent with exible metal 9 3 PAC reinforcement to adjust it to theanatomical as conditions determine by visual inspection
34. The Ikus power switch toggle switch should always be in the Hposition even if the Ikus is set to 0 position at the main switch keyswitch Otherwise the driving unit may stop completely because thebatteries have become fully depleted 1kus 0 The lt NumLk gt key on the laptop must be deactivated The status LEDon the laptop identified by a lock symbol and ora numeral e g 1 should not light see figures 3 to 5 3 page 45 The Ikus must ahways be connected to the power supply when it isswitched on This is the only way to ensure that the start up test seesection 6 1 3 Starting the monitor program page 67 is performedcompletely and possible malfunctions c
35. s Nn Secure each connection between blood pump and cannula with at leastone cable tie as soon as the proper function ofthe EXCOR jsestablished see section 8 11 Securing the connections page 94 0therwise there is arisk ofloose connections and inadequate bloodsupply to the patient EXCOR 1 P 94 8 11 On 406 clean At least every 4 hours visually check that the blood pump s is are filling and ejecting completcly overa period of several pump cycles If apump is not filling and or ejecting completely institute heappropriate c
36. s NW Make sure that the lt NumLk gt key on the laptop is deactivated Thestatus LED on the laptop identified by a lock symbol and or a numeral e g 1 should be off see figures 5 to 5 3 page 45 lt NumLK gt 1 LED P 45 5 1 5 3 Only use the USB sticks provided with the device for saving data Neverconnect any other USB stick to the laptop USB USB
37. When operating the manual pump with 1 hand do not block the valveswith your feet see c in figure 14 3 and in fig 14 4 page 144 144 14 3 14 4 c 1 1 14 Ambient conditions Trotect the Ikus from exposure to noisture and wetness Never store oroperate the Ikus in a damp environment e g bathroom etc Otherwise there is a risk of functional limitation and or Ikusmalfunction ln terms of electromagnetic compatibility EMC the lkus is subject tospecial precautions Avoid exposure to strong electromagneticradiation as generated by mobile cell phones and cordless phoneswhen switched on electromagnetic security systems etc see chapter16 EMC tables page 173 Otherwise there js a risk of electromagneticdisturbances and fault free functioning of the Ikus cannot beguaranteed 1 1 14 Ikus
38. gt 1 2 3 IABP 1 1
39. Use 1 of the 2 USB sticks provided with the device to save the data Donot connect any other USB device to the japtop e g wirelesstechnology USB 2 1 USB Make sure that you ahways have the USB stick inserted and that there issufficient capacity on the stick Otherwise the LOG files might get lostas they are deleted from the hard disk as soon as they have beentransferred onto a USB stick USB USB 421
40. 4 45 5 4 0 5 0 U 393 6 5 1 2 2
41. 4 4 5 4 U 8 CPB 8 4 7 lt 2 3
42. s Nn Do not install any additional sofhvare on the laptop Otherwise there isa risk of damage to the original Ikus software Risk of total malfunctionof the Ikus kuns Ikus s Make sure that the lt NumLk gt key of the japtop js deactivated Thestatus 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 lt NumLK gt LED
43. lt Enter Pump output measurement activaled gt MRD
44. 1 2 Ikus Ikus 1 34 lkus Ikus 2 5 6 Ikus Ikus 3 6 Ikus Ikus Ikus EXCOR Pediatric The Ikus should not be used adjacent to or stacked with otherequipment fadjacent or stacked use is necessary the Ikus lkus
45. Ikus lkus ikus P 152 14 4 Ikus P 153 14 3 14 4 1kus 15214 5 153 s a 3 7 Transportation and packaging 3 7 Only proceed as described below if a replacement Ikus is available toassume the support of the patient as described he
46. When using staged cannulae or a connecting set the pumping ratemay not be greater than the respective value found in table 14 9 p 104 as the pump wili not eject its full volume at higher rates P 104 14 9 At least every 4 hours visually check of blood pump s for depositformation 4 0 1 1 9 Cleaning the components 1 1 9 Cleaning the pump and the drive line Do not use any acetone orpetrolenm based products near the pump or drivelines We recommend using only water or alcohol to clean the pump and thedrive line 1MPORTANT Do not use any corrosive or colored solutions or organicsolvents to clean the blood pump or drivelines as they may alter 1hesurface of
47. 6 1 2 Switching on the Ikus 6 1 2 Ikus a 439 clean
48. Ss 1 1 2 3
49. Always keep manual pump attached to the Jkus Otherwise in anemergency situation the adequate support of the patient is notguaranteed Ikus Call one or more persons to assist Otherwise in an emergency Situationthe adequate support of the patient is not guaranteed 1 The driving tubes and cannulae should be arranged in a bend freeposition Otherwise in an emergency situation the adequate support ofthe patient is not guaranteed
50. 429 clean When connecting the blood pump s pay attention to the direction ofthe arrows on the inflow and outflow stubs These show the direction ofthe blood flow Type of support Anastomosis of inflow cannula to Points upwards LVAD apex blood chamberRVAD atrium air chamberLVAD atrium air chamber LVAD RVAD LVAD Finally the driving tube is connected to the Ikus The Ikus js started andthe parameters are gradually adjusted see section 6 2 10 Checking theparameters when the pump is started and adjusting them pa
51. 444 8 9 10 1 3 1
52. 7 OT RA 8 BVAD 9 10 11
53. 6 2 7 Ikus Ikus 3 It is not nossible to select a larger blood Pump and or a higher rate forthe right pump than for the left one The list of Pump sizes available forthe right pump is limited accordingly 6 2 8 De airing the blood pumps in single 6 2 8 step mode Select pump size The sizes written in
54. 1 BXCOR Pediatric Ikus 2 Ikus gt 1 MRI 2 EXCOR Pediatric lt gt 1
55. 9 EXCOR Pediatric 10 11 12 2 gt
56. 12 USB USB kus
57. 1 1 12 When replacing a blood pump follow the instruction given here Otherwise the duration of the pump stop will be prolonged and thepatient might suffer from inadequate support The blood pump may only be replaced under sterile conditions When connecting the blood pump s pay attention to the direction ofthe arrows on the inflow and outflow stubs These show the direction ofthe blood flow
58. 1 1 3 Device configurations 1 1 3 EXCOR was not designed to be used in combination with othersystems nor do any of the currently granted approvals allow for this Use by untrained personnel poses a risk to the patient and to theEXCOR EXCOR EXCOR 400 clean In univentricular operation also for an RVAD Always connect thedriving tube ofthe blood pump to the red marked connector RVAD
59. 4 5 1 Start program 6 ID Enter 7 Select operating mode 8 Biventrioular BVAD Enter Step 1eft Step right OK 9 Drive pause Drive pause x 1
60. s 407 clean Only use USB sticks included within the delivery of the EXCOR to storedata Do not use any other USB sticks with the aptop Risk that a wrong USB stick js not recognized If a wrong USB stick isrecognized then it may not be possible to save the data EXCOR USB USB USB USB Never connect other USB devices to the USB port of the laptop thanthe delivered USB sticks Otherwise there is a risk that the batteries ofthe 1kus will be discharged too fast USB
61. Ifitis necessary to clamp any other part of the cannula that js notcovered with velour cover the part of the cannula that will be clampedwith a gauze sponge If the connector set is being used Secure each connection betweenblood pump and cannula with at least one cable tie 1 If an EXCOR connecting set is required for implantation and the lengthof the tube part needs to be reduced the tube part should be cut butonly to achieve the following minimum lengths Part Number Diameter Reduction Minimum LengthA12 016 16 to 12 mm 90 mmA09 012 12 to 9
62. 7 a 1 a we w Ce B 3 2
63. 1kus 13 9 If this is the case the Ikus will not generate an acoustic signal in analarm situation or it will generate a wrong signal Observe themessages displayed in the message window carefully and look out forthe visual alarm signal in the display and operating panel Do notoperate the Ikus without supervisionl Ikuvs Ilkus 13 12 Measurement discrepancy in main computer backup computer 13 12
64. 2nw 9 10 2 1 50n 2 3 4 1 2 3
65. 6 2 4 Select the cannula size 6 2 4 An overview of the messages hat might occur during the start test isgiven in section 13 24 Error messages during the start up test page142 P 142 13 24 6 2 6 Setting the start up parameters 6 2 6 The display FAULT in the parameter table indicates that the start testhas detected a fault Such faults may be caused for instance byoperating errors when the system was last shut down or during thestart up procedure 6 2 7 Connecting the blood pump S to the Ikus The Ikus will repeat the connector seal test up to 3 times If the test isstill not successful the system will switch itself off Please contact theemergency hotline FAULT
66. 10 1 2 lt gt lt 5 4
67. 36 S 36 4 1 Drive pause Drive off x Message window 2 Switch drive off with main switchl 0 5 Q 2 2 uy 446 5 1 5 1 1
68. lt 2 1 1 w lt lt
69. The cable tie covering the EXCOR cannula on the stub of the bloodpump should be removed carefully Important never use a Sharpinstrument for example a scalpel or scissors to remove the cable tie This may cause damage to the cannula EXCOR If the left pump is being replaced in a VAD providing biventricularsupport the right pump must also be stopped while the pump is beingreplaced in order to avoid overloading the pulmonary circulation danger of pu
70. lkus 6 If the LEDs of the charge indicator flash on and off or if the messageBatteries discharged use power supply is shown switch to mainsoperation immediately LED Batteries discharged use power supply 2 General information 2 2 6 Storage and durability 2 6 The expiration date of each EXCOR product is found on the productlabels located on both the outer and inner packaging The pumps cannulae and accessories must not be used after the expiration dateand even not be re sterilized Otherwise there is a risk of _patientinfection EXCOR
71. 6 lkus 1 lt 1 SUml 2 2 3 50mL 4 5 6 7 2 EXCOR Fediatric 1 EXCOR Pediatric 2 1 1 L
72. lcardio 650 i 5 BMA 2 TEL 078 304 6101 FAX 8 304 6103 Berlin Heart GmbH 44 398 5 1 2 clean 1 Important safety information 1 1 1 Warmings 1 1 Before using EXCOR read the EXCOR nstructions for Use carefully Only qualified medical personnel trained specifically in the use of thesystem are permitted to work with EXCOR Training courses can bearranged with Berlin Heart Inc Use by untrained personnel can pose arisk to the patient and the EXCOR EXCOR Berlin Heart
73. Care must be taken to ensure that the cannulae come to rest in a stableposition free oftension Do not touch or manipulate the silicone cannulae with pointed orsharp edged objects ce g surgical instruments 428 clean Using a pair of forceps firmly grip the flat end piece of the tunneling tipand pull it through the cannula tunnel and the skin incision Important Do not rotate the cannula while pul
74. Make sure that the Ikus is standing frmly and securely in the crate andthat the crate js closed and sealed properly Ikus 438 upside down on the Ikus on the Ikus The temperature of the Ikus clean ga 6 ai A he crate must always be transported as E marked Do not tip the Ikusdriving unit IE 6 tk MS stored in the transport crate or tum it Always observe a resting period of 6 hours kus opex after each transportationbefore switching 6 6 Always observe
75. The following procedures and therapies have been tested in regard totheir interaction with the Ikus and no harmful effects were found however these procednres and therapies must only be applied after consultationwith the treating physician Additionally the manufacturer doesnot guarantee that equivalent devices will not interfere Diathermy XX Tays Computed tomographY Ikus s i 413 clean X 1 2 1 VAD placement technique 1 2 1 VAD Implantation anesthesia There should be an a
76. C18V 020 5 m L25cm head 19 mn C22V 004 12 8 mm L28cm head 22 mm C25V 004 12 d mm L28cm head 25 mm E22V 002 12 mm L33cm head 22 mm C26V 002 12 mL33cm head 26 mn 3 1 3 2 11 ceoe o21 1 C606 004 12 9mL2Bcm60 B C85G 004 1279 mm B C606 002 12mL33cm 60 B CB5G 002 12 mL33cm 85 B SE AD9 009 9979 mm A12 012 12712 m 5 AD6 009
77. ELS0 5 20 5 759 2 BS4 0 5 mA Mm 42 5 3 91 796 ELs0 4 7 27 5 66 7 SAE 0 068 1 411 SAE 96 2 1 376 sAE 107 SAE 0 078 0 25
78. 2 1 441 5 1 4 1 1 _Q 1 500ml 2 2 3 50mL 4 5 6 7 2 EXCOR Pediatric 1 EXCOR Pediatric 2 1 1 UniVAD Single VAD BVAD 3 4 5
79. 14 4 Connecting the patient to a The sequence of operations below must always be followed Do not switch the Ikus off umless the batteries are fully charged i e allyellow charge indicator LEDs are an Keep all driving tube connectors covered at all times when not in use After changing over to biventricular operation the device is operating inseparate mode All paranneters are reset to the default parameters seeTab 14 3 Default standard parameters page 132 The patientcustomizedparameters have to be adjusted again 14 4 kus LED Ikus P 152 14 3
80. Milrinone 0 73 ng kg min should be started 12 hours priorexplantation ACE inhibitor B Blocker and Spirinolactone should be notstopped 0 75 5g kg 12 ACE s 12 2 2 Explantation after biventricular support 12 2 2 When switching on the Ikus always make sure that the Ikus is switchedon first and then the laptop and never vice versa Otherwise there is arisk that during the start test error messages are falsely generated At least daily the EXCOR cannulae should be inspected for signs ofwear or damage ADVICE To avoid needless kinking of the cannulaeuse a mirror for inspection of the bottom side of the blood pump At least every 4 hours check visually that the blood pump s is are filling and ejecting completely over a period of several pump cycles If apump is not filling and or ejecting completely then take theappropriate corrective action Ikus Ikus
81. P 85 8 2 s If it is necessary to apply a clamp directly to the cannula jn order to pullthe cannula through the skin the following procedures should beobserved Position the clamp at the distal end of the cannula After the cannula has been pulled through the skin cut off anddiscard the part of the cannula where the clamp was applied Ifit js necessary to clamp any other part of the cannula that is notcovered with velour cover the part of the cannula that will beclamped with a gauze sponge
82. 5 1 2 2 Ikus 1 2 1 445 2 3 1
83. State of the blood pumps when hey are initially connected filled withsterile jnjectable saline de airing needle in place To allow easjerhandling the driving tubes are not connected until the inflow andoutflow cannulae have been connected to the pump see section 8 9 Connecting the blood pumps to the cannu ae page 92 3 P 92 8 9 Each de airing step Step left Step right carries out half a pump cycle systole or diastole the 1th step being a diastole Normally several deairingsteps are required for each pump In single step mode hepumps will operate using he pressures Shown in the parameter table It will not be possible to switch to the standard view unless at least 1de airing step has been completed for each connected pump Step left 1 S
84. The distal end of the cannulae can be frimmed At least 5 cm 2 inches of material without polyester velour covering should remain to allowvisual inspection of the cannula titantum connector junction Otherwise there is a risk that possible deposits if formed cannot bevisualized 5cm 2 Ensure proper placement of the cannulae especially with respect toorientation of the LV apex cannula to prevent suction of the myocardialwall Prior to initial operation of the blood pump s minimal in
85. 448 1 2 EXCOR Pediatric Ikus 3
86. Ikus Ikus Ikus Ikus 1 2 1kus kus 1 3 4 1Ikus Ikus 2 5 6 1Ikus Ikus 3 6 Ilkus kus Ikus EXCOR Berlin Heart GmbH Berlin Heart
87. Secure the driving tubes and cannulae to the blood pump S as soon asthe proper function of the EXCOR is established see section 8 11 Securing the connections page 94 EXCOR P 94 8 11 3 4 Switching between mains and battery operation 5 4 At least every 4 hours visually check that the pump s is are fillingand ejecting completely over a period of several pump cycles If a pumpis not filling and or gjecting completely appropriate measures are tobe taken 4 The Ikus power switch toggle switch should ahways be in th
88. s BVAD If the left pump is being replaced the right pump must also bestopped while the pump is being replaced Otherwise there is the riskof pulmonary edema BVAD 1f the replacement pump has a larger volume than the one beingreplaced the use of a connector set must be considered the corresponding Darameter in the view Pump size and single stepmode must be updated Pump size and single step mode 14 1 3 Replacing the left blood pump LVAD BVAD BVAD Ifthe left pump is being replaced the right pump must also bestopped while the punp is being replaced Othe
89. 1 H If the emergency pulse mode is activated while the backup system isalready active the kus is no longer able to drive both pumps In thiscase the patient must be supported immediately with the replacementlkus Use the manual pump while securing the replacement Ikus seesection14 4 Connecting the patient to a replacentent Ikus page 152and section 14 5 Driving blood pump s with he manual pump Dage133 resp Otherwise there is the risk that the patient will not besupported sufficiently 1 1 12 Replacing the blood pump s Ikus j Tkus 1kus P 152 14 4 kus P 153 14 5
90. 1 2 2 Ambient conditions 1 2 2 Only qualified medical personnel trained specifically in the use of thesystem are permitted to Work with EXCOR Training courses can bearranged with Berlin Heart Inc To prevent the batteries from being discharged by mistake ensure thatthe power switch toggle switch js set to position even if the 1kus jsset to 0 position at the main switch key switch EXCOR Berlin Heart lkus 0 1 2 3 Caution while using the Ikus 1 2 3 Ikus While the Ikus is being operated keep it connected to the s
91. 3 4 EXCOR 5 6 7 8
92. 4 2 3 4 45 5 4 0 5 0 0 6
93. The units may only be operated with the disposable products andaccessories specified in this document Also see section 13 1 2 Overyiew Relationship body weight pump size Dage 159 Otherwisethere is a risk of fhnctional Himitation and or damage to the Tkus Failureto observe this stipulation will invalidate all warranty agreements byBerlin Heart Inc P 159 13 1 2 13 1 2 159 Ikus Berlin Heart The connection between the connector External alarm Nurse call andthe jnternal alarm system of the clinic is not failsafe The use of thisfeature does not release the user from supervising the Ikus and thedisplayed messages and alar
94. 2 1 2 LAD 2 cm 4 LAD 5 5 10 Prolene3 0 1 0 7
95. lIkus 5 4 2 3 Power supply 4 2 3 To lift the Ikus use only the lifting bars at the lower edge at each side ofthe unit to hold and lift it Never attempt to lifl the 1kus by its handle The Ikus must always be lifted by at least 2 people preferably 4 kus Ikus kus 2 4 Rolling the Ikus over sloping surfaces ensure that the person pushing itis strong enough to push the Ikus in a controlled manner The slope ofthe surface may not be steeper than 10 exception packing unpacking of the Ikus into from the tra
96. 7 8 9 10
97. IR 1 1 7 P 162 5 1 10 15 1 10 162 EXCOR Pediatric Ikus The cannula diameter may be adapted only once either by using astaged cannula or a connector set Multiple staging could result inlimited pump performance and compromised hemodynamics 1
98. s DJ In order to avoid air being sucked into the blood pump through thecannula anastomosis adjust the parameters gradually If air does enterthe system sconnect the driving tubes from the 1kus Ikus s ox 418 clean and de air thesystem using the de airing needle Continuously monitor all settings 5 3 3 Drive OFF switching the Ikus off 5 3 3 Ikus 2 Once the de airing needle has been removed it cannot be re inserted
99. 440 5 1 3 1 1 2 1 1 2 3 4 5 2 1
100. If it is necessary to apply a clamp directly to the cannula in order to pullthe cannula through the skin the following procedures should beobserved Position the clamp at the distal end of the cannula After he cannula has been pulled through the skin cut off anddiscard the part of the cannula where the clamp was applied If it is necessary to clamp any other part ofthe cannula that is notcovered with velour cover the part of the cannula hat will beclamped with a gauze sponge The skin incision must be slightly smaller than the cannula diameter toensure good ingrowth but large enough to prevent
101. 2 gt
102. 1 1 15 Interaction with other procedures and therapies 1 1 15 The following procedure is not possible Magnetic resonance imaging IFEXCOR is used in interaction with other procedures and therapies observe the movement of the membrane to determine whether theblood pump is filling and ejecting completely If a pump is not fillingand or ejecting completely stop the interacting procedure or therapyand institute the appropriate corrective action In terms of electromagnetic compatibility EMC the Ikus is subject tospecial precautions When exposing Ikus to the procedures andtherapies listed below please observe EMC regulations given jn chapter16 page 173
103. 2 3 4 4 5 4 U 6 7 CPB 8
104. 424 clean When using staged cannulae or a connecting set do not set a Dumpingrate gt 100 bpm as the pump will not eject its full volume at higherrates With these cannulae rates gt 100 bpm are to be avoided 100 bpm 100 bpm Manipulations during implantation can severely influence the inflowtemporarily wait for the situation to stabilize before adjusting thevalues s The patient should recejve the same treatment as is usual after anyother major cardiac surgic
105. Do not use any adhesive on the velour coating of the cannula as it isdifficult to jemove and may adversely manipulate the cannula Do not use organic solvents near the EXCOR Pediatric such aspetroleum ether or turpentine oil as they could damage the cannulaeand the pumps The plastic parts must not get in contact withchlorinated hydrocarbon e g chloroform thinners e g acetone naphtha toluol xylene heptane or Similar compounds EXCOR
106. lt 9 2
107. Do not start the pump s until all air has been removed 5 2 2 Shutting down the monitor program 5 2 2 Once the de airing needle has been removed it cannot be re inserted s 1 5 2 7 Adjusting the parameter values 5 2 7 Only remove the de airing needle after all air has been removed fromthe blood pump the blood pump is running and the parameters havebeen adjusted see section 6 2 10 Checking the parameters when thepump is started and adjusting them page 73 and section 8 10 Removing the de airing needle page 93 P 73 6 2 10 P 93 8 10
108. 10 EXCOR Pediatric 11 EXCOR Pediatric 12 2
109. Ikus 23 24 2 452 25
110. replacement Ikus 14 5 Driving blood pump s with the 14 5 manual pump Keep all driving tube connectors covered at all times when not in use To lift the 1kus only use the lifting bars situated at the lower edge oneach side of the unit to hold and lift it Never attempt to lift the Ikus bythe handle Ikus Ikus To transport the Ikus only the supplied original tramsport crate must beused Ikus
111. 17 6 18 LED 19 20 USB USB 21 1 22
112. 3 4 5 6 7
113. that the bloodflow in the cannula is not lt restricted For the suture use an appropriate suture material It should be anonabsorbable EXCOR If it js necessary to apply a clamp directly to the cannula in order to pullthe cannula through the skin the following procedures should beobserved Position the clamp at the distal end of the cannular After the cannula has been pulled through the skin cut off anddiscard the part of the cannula where the clamp was applied
114. 7 EXCOR Pediatric EXCOR kus 1 a ga M e CWC 9 Cc 7
115. EXCOR BB 399 clean If there is any malfunction of the Ikus while the driving unit isconnected to the patient the Ikus must immediately be replaced Ikus Ikus 1 1 1 Storage and durability 1 1 1 The expiration date of each EXCOR product is found on the productlabels ocated on both the outer and inner packaging The pumps cannulae and accessories must not be used after the expiration dateand even not be re sterihized Otherwise there is a risk of patientinfection EXCOR
116. Ikus 1Ikus 1 1 11 Errors and corrective measures 1 1 11 409 E clean Any time an error mesSage has occurred visually check that the bloodpump s is are filling and ejecting completely over a period of severalpump cycles then address the error message with the appropriatecorrective actiOn Enter Pump output measurement activatedl
117. When using a cell phone in the immediate environment of an Ikus inoperation please make sure to keep a distance of at least 0 77 m Forfurther information please refer to chapter 16 EMC tables page 173 Ikus 0 77m P 173 16 EMC 1 When using an RFID device in the immediate environment of an Ikus inoperation please make sure to keep a distance of at least 1 m Forfurther informatlon please refer to chapter 16 EMC tables page 173 Ikus RFID lm P 173 16 EMC Protect the 1kus against temperatures below 10 C and above 30 C this includes extreme temperature changes and overheating e g directsunlight or from heaters Otherwise there is a ris
118. P 84 8 2 8 8 Shortening the cannulae if necessary 8 8 If an EXCOR connecting set is required for implantation and the lengthof the tube part needs to be reduced the tube part should be cut butonly to achieve the following minimum lengths Part Number Diameter Reduction Minimum LengthA12 016 16 to 12 mm 90 mmA09 012 12 to 9 mm 75 mmA06 0099to 6 mm 60 mm 8 9 Connecting the blood pumps to the cannulae EXCOR A12 016 16 12 mm 90 mmA09 012 12 9 mm 75 mmA06 0099 6 mm 60mm 8 2 8 9 Ensure hat cannulae blood pump s and driving tnbes are not subjectto external forces and are free of kinks or sharp bends
119. 3 2000 6 4 5 1 Berlin Heart 2 3 lt 2000 2000 lt 6
120. 12 4 13 1 1 1 1 2
121. Do not start pump operation until the blood pump is completely free ofair clean Only use blood pumps which have an ES ed HS packaging 7 5 1 Inserting the de airing needle 7 5 1 The membrane must be kept in the end of diastole position Keep theclamped membrane set connected to the blood pump 8 Implantation surgical procedure 8 mmeoiom must ikiepoied rro idi Rk solidity safeness and tightness
122. The Ikus power switch toggle switch must be switched on during hefirst startup and remain set to I position Its position should never bechanged Otherwise there js a risk that the batteries will not be fullycharged after battery operation The Ikus is designed for stationary operation and to be run on mainspower referred to as the mains in this instruction for use Do not runit on battery operation unless this is absolutely necessary e 8 whenmoving the patient within the clinic or during a mains failure Always take the battery capacity limits into consideration when usingthe system When the system is working in battery operation thepatient must be accompanied by a person trained to use he manualpump Thus he patient shall be guaranteed care in am emergency Ikus 1 Ikus
123. Select operating mode 2 1 2 3 1 4 2000 6 2000
124. Rates lt 60 bpm are intended to be used only for implantation andexplantation lt 60 bpm 1kus 434 clean Never use the Ikus with a rate lt 60 bpm without constantsupervision lt 60 bpm Under certain circumstances the messages Check left pump anddriving tube or Please check right pump and driving tube are notgenerated with the 10 ml EXCOR blood pump due to the low volume ofair which is moved in the pump Therefore in pumps of this size payspecial attention to the movement of the membrane and ensure thateach pump fills and empties completely 10mL EXCOR Please check left pump and driving tnbe Please check right pump and driving tube
125. The laptop must be switched off before the USB stick is inserted in orremoved from the USB port Check all the information and messages in the message window of themonitor Program at least every 4 hours Ifthere is a message thatindicates action must be taken take the appropriate action and ifnecessary contact the Berlin Heart Inc emergency hotline USB USB USB 4 Berlin Heart 1 2 4 Battery replacement and disposal 1 2 4 When switching on the Ikus ahways switch the Ik
126. 2 1 lt 3 1 PU 3 4 5 2
127. jkus 5 Instructions for use Ikus 5 Ikus Switch the Ikus on 2 hours before its jntended use in order toadequately charge the batteries and so that a start test can beperformed to detect any possible faults in the device During thisperiod always connect both tank units to he Ikus see section 6 1 1 Connecting the tank unit Page 66 2 Ikus lkus P 66 6 1 1 2
128. clean Never disconnect the kus from the mains when the circuit breaker orthe internal battery fuse are activated This will cause the driving unit tostop immediately Ikus s The Ikus stops immediately The blood Pumps are no longer beingdriven Ikus Whenever the Ikus js running in battery operation the patient mustalways be accompanied by a person trained to use the manual pump Ikus 6 1 Preparatory steps outside
129. 01 Keep all driving tube connectors covered at all times when not in use The Ikus power switch toggle switch should always be in the I position even if the main switch key switch is in the 0 position Othenyise there is a risk that the drive may fail due to the Ikus batteriesbeing totally discharged Ikus 0 Ikuns 5 5 Changing over from univentricular to biventricular operation
130. At least every 4 hours check visually that the blood pump s is are filling and ejecting completely over a Deriod of seVeral pump cycles If apump is not filling and or ejecting completely then take theappropriate corrective action 4 431 clean Under certain circumstances the message lefMright pump is not fillingadequately jn some circumstances is not generated with the 10 miEXCOR blood pump due to the iow volume of air which is moved jn thepump Therefore in pumps of this size pay Special attention to themovement of the membrane and ensure that each pump fills andempties completely 10mL EXCOR Please check left pump and driving tube 1
131. seesection 6 1 3 Starting the monitor WE 2 i 6 1 3 67 Only connect the mains cable of the Ikus driving unit to groundedmains power outlets The supply voltage has to conform to the voltagereduirements indicated on the Ikus identification plate Only connectthe mains cable of the IKus driving unit to suitable power outletscomplying with the electrical safety regulations of the country in whichit is being used Otherwise there is a riSk of electrical shock or damageto the EXCOR systeml Ikus Ikus Ikus HH EXCOR
132. EXCOR Before starting the Ikus make sure that a replacement Ikus is availablein the hospital If a replacement Ikus is not available there is a risk thatthe patient cannot be cared for in the event of device malfunction The general rule is 1 replacement lkus if 1 or 2 systems are in use 2 replacement Ikus if 3 or 4 systems are in use 3 replacement lkus if 5 or 6 systems are in use If more than 6 systems are jn use the number of replacement Ikus hasto be 1 2 of the active systems On the system EXCOR only use components of this system Never useother components than those delivered by Berlin Heart GmbH BerlinHHeart Inc Otherwise the warranty is no longer valid
133. 5 IAEP 1 4 2 3
134. necrosis 8 7 1 Creating a transcutaneous tunnel for arterial cannula 8 7 1 Care must be taken to ensure that the blood pump and cannulae cometo rest in a stable position Do not touch or manipulate the silicone cannulae with pointed orsharp edged objects e g surgical instruments Using a pair of forceps firmly grip the flat end piece of the tunneling tipand pull it through he cannula tunnel and the skin incision Important Do not rotate the cannula diameter to ensuregood jngrowth but large enough to prevent skin necrosis
135. w w 99 3 w w 5 308 6 350 wm x jm x w x a F W m eg 1 1 W 0 1 10 25 96 203 1 m w 2 10 m 1 2
136. 7 2 8 9
137. 35891100 EXCOR Pediatric
138. 10 11 12 13 14 15 16
139. 4 LED 5 1 0 6 7 8 2 9
140. A 1 3 2 B 4a 1 5 Ct 3 Fy 6 asmre gt 2 0 6mmL25cm lt gt 1 1 hE EH A RE gt I 12 9mm L27cm 627A 001 12mmL27om 392 2 1 2 2
141. should beobserved to verify normal operation in the configuration in which it willbe used Tkus The system EXCOR Pediatric and its EXCOR Pediatrie EXCOR Pediatric Unintended use can pose a risk to the patient and the EXCOR coniponents are permitted to beused only by prescription of the attending physician EXCOR Pediatric EXCOR Do not use the EXCOR if there is any visable damage of the 1kus or anyof its components Ikus
142. 3 4 5 6 442 7 2 mm 8
143. 435 clean 5 1kus Continue to operate the Ikus on mains There is a risk of totalmalfunction if amp VER 1 13 17 Insufficient battery charge Only 13 17 limited battery operation Ikus Keep Ikus connected to mains Dangerof total shutdown after briefbattery operation 13 18 Ikus Ikus must be kept connected to the power suppl
144. the Ikus might perform atest phase which Ikus means that the blood pump of the correspondingsystem is briefly stopped for the duration of this test Discrepancy in pressure meaSurement system 1 2 3 The information message Discrepancy in 1 2 Dressure measurement system 1 2 or 3 js ce not accompanied by an acoustic signal 6 A 14 Troubleshooting and correcting faults 14 14 1 Replacing the blood pump s 14 1 When replacing a blood pump follow the 3 1 instruction given here Otherwise the duration of the pump stop will be prolonged and thepatient might suffer from ina
145. Check all information and messages in the message window of hemonitor program at least every 4 hours Take the necessary measuresand if required notify the service department of Berlin Heart Inc Themessage window only shows a limited number of messages Otherwisethere is a risk that older information and messages can no longer beread and therefore corrective actions for older messages may no longerbe possible 4 Berlin Heart Ifa message with the content Contact customer service now isdisplayed jn the message field on the laptop replace the Ikusimmediately see chapter 13 Error Messages and correctiVe measures page
146. Ikus Ikus EMC lkus P 173 16 EMO Ikus
147. 9679 mm AD9 012 9 12 mm gt 1 1 1 2 3 4
148. Only use blood pumps which have am undamaged aluminum coatedouter packaging 404 clean The long term storage conditions for all sterile products must beobserved temperature 15 C to 25 C relative humidity 33 to 50 Store in a dry place Otherwise there is a risk that he product is nolonger sterile 15 25 3 30 In order to prevent infection use strict aseptic techniques duringinplantation and exercise extreme caution throughout the period ofEXCOR cardiac support Danger of infection EXCOR
149. Do not remove the de aining needle until all air is removed the bloodpump js running all parameters have been adjusted and the chest hasbeen closed see section 6 2 10 Checking the parameters when thepump is started and adjusting them age 73 8 11 Securing the connections All connections have to be secured by at least 1 cable tie 2 cable tiesmay be used Exception connection between drive line and drive lineconnector of the blood pump 1 cable tie only P 73 6 2 10 8 11 1 2 1 9 1mplantation anesthesia There should be an adeqguate supply of pre matched stored blood freshfrozen plasma and platele
150. between velourand silicone Do not kink th 1 o not kink the cannulae needlessly a Otherwise there might not besufficient AM MM Moreover cannulae might Ai Re ound care and treatment Before _ 93 cleaning the wound see 10 3 Cleaning of RA ME the wound page 101 put on sterile 24 disposable gloves capand mask Weaning If the patient does not meet the eligibility criteria at any timeduring he weaning process Resume pumping at rate prior to anyweaning initial rate IR 1 1 7 System 1f a non matching pump cannula combination see section 15 1 10 Pump cannula combinations page 162 was chosen use only theconnector sets provided with the system in order to minimize the riskof clots at the junctions Be aware of increased risk of thrombosis andhemolysis
151. EXCOR Pediatric 70522020 amp JAN 2 EXCOR Pediatric EXCOR Pediatric 33891100 JAN 3 Ikus EXCOR Pediatric ExCOR Ikus 70560000 M JAN 454
152. 5 6 5 LED 7 8 ABP gt 1 1 2 lkus Ikus 3 4 kus
153. 1 lt lt E Ikus 36 36 4 1 Drive pause Drive off x 1 window 2 Switch off drive with main switch 3 F101 1 ND 0 5 1 396 2 lt
154. 3 9 10 1 2 1 1 3
155. Before putting the Ikus into operatiOn check that the ambient conditionsare suitable see section 15 2 Technical specifications page 163 Ikus 7 Implantation Preparations in the operating room P 163 13 2 7 7 1 Preparing the components and materials required 7 1 Selection of blood pump S see section 15 1 Overview Product rangeand possible combinations page 159 P 159 15 1 7 3 Unpacking the sterile components been delivered in undamagedsterile condition sterile packaging intact expiration date not expired 7 3 i a TIY use sterile components whi LV ET s a a hs 425
156. Between the error message Measurement discrepancy in maincomputerl and the 2nd real error message there can bea delay ofSeveral seconds At any case wait for both error messages IMeasurement discrepancy in main computer 2 13 14 Temperature sensors 8 digit binary code gt gt 13 14 lt lt 8 gt gt Do not use water or other liquids to cool the Ikus Otherwise there is arisk of short circuit and or device malfunction Ikus 13 16 Batteries discharged battery operation not possible 13 16
157. Ikus 433 E LL clean After changing over to biventricular operation the device is operating inseparate mode All parameters are reset to the default parameters seeTab 14 3 Default standard parameters page 152 The patientcustomizedparameters have to be adjusted agam P 152 14 3 21 s Do not switch the Ikus off unless the batteries are fully charged i e allyellow charge indicatorLEDs are on LED Ikus ot Replacing the blood pump due to growth of the patien
158. ikus Keep all driving tube connectors covered at all times when not in use 14 3 Emergency pulse mode 14 3 Only Berlin Heart GmbH Berlin Heart Inc service staff or personsauthorized by may replacethe batteries and dispose of them in accordance with the respectiveregulations the Berlin Heart GmbH service department BerlinHeart GmbH Berlin Heart BerlinHeart GmbH s The operator i e the hospital using the system is responsible forinstruction and care ofthe patient The patient must be instructed onsafety risks and caufionary meaSures moisture temperature electromagnetic fields etc
159. EMC Ikus Ikus P 173 16 EMC For the following procedures and therapies the rmanufacturer does notexpect any harmful interaction with the Ikus due to the general electromagneticshielding of the device see chapter 16 page 173 However these procedures and therapies must only be applied after consultationwith the treating physician Radiotherapy Nuclear diagnostics nuclear therapy Electro stimulation therapy Therapeutic ultrasonic treatment e g Iithotripsy External defibrillation Ikus P 173 16
160. Ikus The systolic driving pressure must be higher than he patient s physicalsystolic pressure lmportant If the systolic duration systole isreduced or if very small cannulae are used it may be necessary in somecases to select a higher value than recommended here The actual driving pressures achieved are Ee influenced by the diameter ofthe cannulae Rs NR x g ge used The following values are merely guidehine Yalues they may not beappropriate in each individual case
161. every 2000 hours ofuse In case of continuous operation approx 3 nonths 3 If the ambient temperature is continuously lt 3 7 above 30 C duringoperation the 30 maintenance interval or life of the batteries js reduced The Ikus shall only be serviced by Berlin Heart GmbH Berlin Heart Inc or those authorized by Berlin Heart GmbH For this reason thisdocument does not contain any cireuit or wiring diagrams Ikus Berlin Heart GmbH Berlin Heart Berlin HeartGmbH Only replacement parts approved by the manufacturer may be used forrepairs and servicing Otherwise there is a risk of functional limitationor permanent damage of the Ikus
162. PU 6 EXCOR Ikus 2 1 3 2 3 3 4 1 1 PU 2
163. 2 1 2 6 6 1 2 1 2 3 389 9
164. 1f any of the components are damaged or if faults occur inform BeriinHeart GmbH Berlin Heart Inc service department immediately Donot use damaged components Berlin Heart GmbH Berlin Heart Only operate the 1kus with the components specified in this document Never operate the Ikus with multiple socket mains adapters or mainsextension cables lkus Ikus Only Berlin Heart GmbH Berlin Heart Inc service staff or personsauthorized by the Berlin Heart GmbH service department may replacethe batteries and dispose of them in accordance with the respectiveregulations BerlinHeart GmbH Berlin Heart BerlinHeart GmbH
165. 2 1 2 3 1 PU 2 443 3
166. 447 Ikus 1 2 1 2 Ikus Ikus 1 3 4 Ikus tkus 2
167. ZS 450 1 1 2 3 4 5 Ss 6 7 8
168. Ikus 416 clean it can notbe guaranteed that the Ikus will restart after connecting it to the mains 4 Description Ikus 4 1kus 4 2 Displays and operating elements 4 2 When the battery charge is low the acoustic signal sounds everyminute The Ikus must be connected to the mains operationimmediately 1 Ikus s on To move the Ikus unit push only using the handle provided for thispurpose Avoid any sudden jerky motion When passing over smallerobstructions exercise extreme caution Dulling the IKus unit backwards i e handle first across the obstruction if necessary Ikus
169. Ikus 2 5 6 lkus Ikus 3 6 kus lkus lkus 4 5
170. Please check right pump and driving tube 10 5 4 Replacing the blood pump due to growth of the patient 10 5 4 In children plan to replace the pump s with a larger pump s in goodtime to prevent the possibility of inadequate support due to an insufficientdischarge rate 11 Anticoagulaton therapy 11 11 3 4 Unfractionated heparin therapy i v Patient gt 12 months 11 3 4 12 If during standard unfractionated heparin therapy 1 Patel
171. 2 4 449 5 1 1 EXCOR Pediatric 2 3 4 5 6
172. EXCOR 99 396 6 308 6 350 1 2 1 390 lcardio 650 004 5 5 5Ma TEL 078 304 6101 FAX 078 304 6103 Berlin Heart GrbH 391 2015 6 5 1 51 000008ZZ00000000
173. 1 50mL 2 3 lt lt 4 5 6
174. Ikus Wait for at least 5 minutes after switching the Ikus off while incmergency pulse mode Otherwise only the service staff will be able torestart it Ikus 5 s 0 Never connect other USB devices e g wireless technology to the USBport ofthe laptop than the delivered USB sticks USB USB USB The use of the manual pump is only permitted for medical personneltrained im the use of it Fay attention to
175. Do not mark or write on the plastic parts 10 5 Regular checks of blood pump s and cannulae 10 5 Everyone involved in caring foran EXCOR patient must be trained tocarry out a visual check to evaluate the filling behavior of the bloodpump s and to detect deposits EXCOR At least daily the EXCOR cannulae should be inspected for signs ofwear or damage ADVICE To avoid needless kinking of the cannu aeuse a mirror for ipspection of the bottom side of the blood pump EXCOR
176. Ikus lt Esc gt lt Enter gt power switch toggle switch should be in position To confirm the change press lt Enter gt the new value is displayed in theparameter table During storage and transportation the 6 1 4 Setting the test parameters 6 1 4 To transport the Ikus only use the original transport crate supplied Ikus Ensure that the Ikus is placed firmly and securely inside
177. In order for a driving tube to be replaced the pump must be stoppedfor a short time If the left driving tube is being replaced jn a drivingunit providing biventricular support the right pump must also bestopped while the driving tube is being replaced in order to avoidoverloading of the pulmonary circulation danger of pulmonaryedema If the left pump is being replaced
178. The sterile components are sterilized using ETO and are packed in adouble layer sterile package Check that the various ayers of the sterilepackaging are not damaged in any way before they are opened Do notuse the components if either of the sterile packages are damaged Thesame applies to sterile components which have exceeded theexpiration date as Printed on he label Otherwise here is a risk that theproduct is no onger sterile EOG An aluminum coated external packaging protects the Carmeda BioActive Surface CBAS of the blood pump and its sterile packagingagain
179. 2mm 9 10 2 1 50mL 2 3 4 1 2 3 1 50mL 2
180. 4 5 2 2 1 2 6 6 1 2 7 1 2
181. 5 6 Ikus Tkus 3 6 Ikus Tkus Ikus 3 4 5 1 6
182. lt gt 1 1kus 0525N 3 5 395 4 60Hz 1 60 mHg 1 OmmHg 30 150bpm 20 70 10 F 30 1 1 A Bot 8 Bt ntrio hI ause Drive pause 7 Select 2
183. 60bpm Ikus 60 bpm lt Under circumstances the messages Please check left pump anddriving tube or Please check right pump and driving tube are notgenerated with the 10 ml EXCOR blood pump due to the low volume ofair which is moved in the pump Therefore in pumps of this size payspecial attention to the movement of the membrane and ensure thateach pump fills and empties completely 10mL EXCOR Please check left pump and driving tubel Please check right pump and driving tube 1
184. ELS0 fe 5 20 5 x 75 2 BSA 0 7 1 5 W 24m R 42 5 3192 91 ELSO ss 7 27 5 mi 66 7 397 SAE 0 088 1 411 SAE 95 2 1 376 SAE 107 SME 0 078 fe s 0 25 EXCOR
185. LED Ikus Ikus restart after connecting it to the mains Ikus LED When
186. 1 1 PU gt 2 3 4 5 6 lt 7 2m 8 4
187. 1 376 SE 107 SE 0 078 gg 0 36 B EcoRs 99 r g 5 350g w gs 1 w m Bx ge 2 5 Hiircardio 650 0047 5 5 TEL 078 304 6101 FAX 078 Berlin Heart GrbH 6MAj2 304 6103 394 3 Ikus 201E j5 OO0008ZZ00000000 0
188. 5 5 Do not switch off and restart the Ikus unless the service consultantrequests to do SO e g in emergency operating mode Ikus 5 6 Moving the Ikus 5 6Ikus The Ikus power switch toggle switch should always be in the I position even if the main switch key switch is in the 0 position1 Otherwisethere is a risk that the Ikus O 419 clean drive may fail in future due to the Ikus batteriesbeing totally discharged jkus Tfthe graphs in the monitor program are frozen not moving and theparameters can
189. 99 1 2 3 2 5 2 2 gt MRI 3 92 4 5 9
190. P 157 14 8 Do not nse water or Huids to cool the Tkus Otherwise there is a risk of ashort circuit or a malfunction of the device lkus 408 clean 1 1 8 Procedures to minimize risk of thrombosis 1 1 8 Ensure complete filling ejection of the pump
191. AC1DOV 3 2 1 y LED
192. 7 1 2 3
193. 9 lt 9 lt 0 1 3 1 lt 2 3
194. ensure removal of all air that is still in the atria or ventricle byperforming single steps step left step right with subsequent removalof the bubbles inside the pump via the de airing needle Otherwisethere is a risk of embolism When removing the de airing needle never pull on the de airing tube but rather only on the de airing needle Once the de airing needle has been removed it cannot be re inserted Rates lt 60 bpm are intended to be used only for implantation andexplantation Never use the 1kus with a rate lt 60 bpm without constantsupervision EXCOR step lcf 1 step right 1
195. he patient will not be supported sufficiently Ifthe emergency pulse mode is activated while the backup system isalready active the Ikus js no longer able to drive both pumps In thiscase the patient must be supported inmediately with the replacementIkus Use the manual pump while securing the replacenent Ikus seesection14 4 Connecting the patient to a replacement Ikus page 152and section 14 5 Driving blood pump s with the manual pump Dage133 resp Otherwise there js the risk that the patient will not besupported sufficiently Ikus 1 Ikus Ikus P 152 14 4 Ikus P 153 14 5 14 4 Ikus 15214 5 153
196. on the mains for at least 6 hoursafter using the battery operation Only after this may the Ikus be run onbattery operation again Ikus LED Ikus 6 Ikus LED 402 clean Ifthe LEDs of the charge level indicator are blinking or the messageBatteries discharged use power supply appears immediately switchto mains operation If the batteries are completely discharged red LEDis lit and the drive continues to run on battery operation there is therisk of a total malfunction of the Ikus and damage of the batteries LED Batt
197. packingunpacking of the 1kus into from the transport crate Otherwise thereis a risk of injury to the transporting persons or of damaging the IKus Ikus kus 10 lkus Ikus ITit is necessary to transport the patient within the clinic ensure that heis accommpanied by a person trained to use the manual pump
198. system is stopped for theduration of this test for approx 10 seconds 10 13 3 1 Replacing a driving tube 13 3 1 In order for a driving tube to be replaced the pump must be stoppedfor a short time If the left driving tube is being replaced jn a drivingunit providing biventricular support the right pump must also bestopped while the driving tube is being replaced in order to avoidoverloading of the pulmonary circulation danger of pulmonaryedema 13 4 Please check left right pump and driving tube 13 4
199. 2 people preferably 4 Ikus lkus Ikus 1kus Ikus 2 4 Rolling the Ikus over sloping surfaces ensure that the person pushing itis strong enough to push he kus in a controlled manner The slope ofthe surface may not be steeper than 10 exception
200. PTT is 60 to 85 seconds 6Monagle P et al Each site should use their hospital calculated therapeuticrange PTT 60 85 6Monagle P ct al a s 6 12 Weaning and Explantation for BTR and BTT 12 BTR BTT 12 1 3 Eligibility Criteria 12 1 3 Continuous reassessment of eligibility criteria is critical to reducing therisks associated with weaning of VAD support Atall times each of theweaning criteria must be satisfied in order to proceed with the weaningprotocol VAD s 1 12 1 4 Weaning Protocol 12 1 4 Rates lt 60 bpm are intended to be used only for implantation andexplantation Never use the Ikus with a rate lt 60 b
201. USB USB Ikus Never connect wireless technology to the USB port of the laptop Otherwise there js arisk of uncontrolled electromagnetic radiationwhich might interfere with other devices The Ikus could also becomemore susceptible to emissions from other devices USB Ikus Prior to connecting and disconnecting the USB stick to the slot thelaptop must be switched off Otherwise there is a risk that the USBstick will not be recognized When removing the stick the stored datacan be lost If the Ikus js operating in emergency pulse mode immediately visuallycheck whether the blood pump s is are filling and ejectingcompletely I
202. by at least 6 h of mains operation 6 6 Ea When the battery charge is low the acoustic signal sounds everyminute The Ikus must be connected to the mains operationimmediately 1 Ikus s fthe batteries are discharged completely red LED lights up there is adanger ofa total malfunction of the 1kus if battery operation is continued and that the batteries will be damaged If this happens it can notbe guaranteed that the Ikus will Messages are only displayed when the monitor program is running When the monitor program is shut down the only indications thatthere is an error message are an acoustic signal and the fact that theindicator lamp on the Ikus handle lights up There is no way of findingout what type of error message has been displayed
203. en Ifthe Ikus is operated by the backup Ikus systen provide the patientimmediately kus Ny with a replacement Ikus 0 Ikus 3 1kus Do not disconnect the Ikus from the mains power supply if the circuitbreaker is triggered Otherwise there is a risk that the driving unitinnmediately stops operating see section 14 8 Circuit breaker andbattery fuse page 157
204. he transportcrate Ikus Do not discard the shipping cratel 6 2 2 Selecting the operating mode view Select operating mode 6 2 2 This chapter describes the technical aspects of commissioning thesystem as well as perioperative and postoperative drive management When commissioning the system it is vital to observe the instructionsgiven in chapter 7 Implanfation Preparations in the operating room Dage 79 P 79 7 6 2 3 Select the pump size 6 2 3 422 clean The drive management procedures d
205. in a VAD providing biventricularsupport the right pump must also be stopped while the pump js beingreplaced in order to avoid overloading the pulmonary circulation danger of pulmonary edema VAD Message Left right flow sensor defective Notify Servicel Do notoperate the Ikus without supervision Otherwise an insufficient supportof the patient might not be detected LefVRight flow sensor defective Notify Servicel Ikus 410 clean If the Ikus is operating in emergency Dulse mode the user mustimmediately visually check the blood pu
206. mm 75 mmA06 009 9 to 6 mm 60 mm EXCOR A12 016 16 12 mm 90 mmA09 012 12 9mm 73 mmA06 0099 6mm 60 mm 426 clean If replacement of an EXCOR blood pump is required the following proceduresshould be observed The cable tie covering the EXCOR cannula on the stub of fhe bloodpump should be removed carefully Important ever use a sharpinstrument for example a scalpel or scissors to remove the cabletie This may cause damage to the cannula If a connecting set needs to be cut for a pump replacement ensurethat there will be sufficient length of the tube part remaining to meetthe minimum length recommendations EXCOR EXCOR
207. mmA06 0099to6 mm 60 mm EXCOR eePA12 016 16 12 mm 90 mmA09 012 9mm gt 12mm 75 mmA06 009 6mm 9mm 60 mm 405 clean Follow exactly he instrucions for using the de airing set Ofherwisethere is a risk of membrane damage Ensure that cannulae blood pump S and driving tubes are not subjectto external forces like compression traction or torsion forces and arefree of knots or sharp bends Prevent the cannulae and connectorsfron being exposed to tensile forces Otherwise there is a risk ofobstrucion of the air and blood flow
208. mode there is a flow alarm 1 for one of the blood pumps The user stops i J the pump operation of the other blood pump andrestarts it This affect that during the jestart the flow alarm will bedeleted MM 9 wether iPs reason continue to exist ornot 13 25 Discrepancy in pressure 13 23 measurement system 1 or system 2 or3 1 2 3 Damage to the Ikus js technically impossible when this messageappears Ikus Avoid a further increase in the rate or alternatively the driving pressurefor parameters set at high values Otherwise
209. necrosis Plan the cannula exit sites appropriately Leave an adequate bridge ofskin and subcutaneous tissue between the cannula exit incisions toprevent breakdown and necrosis of the skin and tissue If possible thecannula exit sites should be on different planes see fig 8 2 page 84 8 6 1 Creating a lranscutaneous tunnel for atrial cannula e 1f possible always use the cannula tunneling tp provided see section8 2 Use of the cannula tunneling tip page 85 to advance the cannulathrough the prepared transcutaneous tunnel P 84 8 2 8 6 1
210. of EXCOR must complete the EXCOR TrainingCourse which provides theoretical introduction and hands on practicalexercises in the operation of this system The training program isorganized and offered by Berlin Heart Inc EXCOR EXCOR Berlin Heart Only use sterile components which have been delivered in undamagedsterile condition sterile packaging intact expiration date not expired
211. red ink in the pop up menu Select pump size can bechosen However they are not the recommended option for eachindividual case see figure 6 5 page 70 In individual cases consideration is to be given as to whether acombination that is not recommended is to be selected The finaldecision on the combination of blood pumps and cannulae is to bereached by the implanting surgeon in consultation with Berlin Heart Inc Clinical Affairs P 70 6 5 Berlin Heart 6 2 9 Starting the blood pump changing to standard view 6 2 9 423 cl
212. the flow directiomarrow on the cannula body except LV apex cannulae C10A 030 C14A 040 CI8A 020 The arrow is aligned with the long side of the cannulahead see fgure 8 6 Ideal position of the LV apex cannula page 87 C10A 030 C14A 040 C18A 020 P 87 8 6 NR s Nn 8 5 2 Creating a transcutaneous tunnel for 8 52 the LV apex cannula Always use the cannula tunneling tip pro
213. the product Cleaning the cannulae and transcutaneous exit site Do not use anyacetone or petroleum based products near the cannulae and thetranscutaneous exit site We recommend using chlorhexidine to
214. 129 Contact customer service now lkus P 129 13 Ifthe emergency pulse mode is activated while the backup system isalready active the Ikus is no longer able to drive both pumps In thiscase the patient must immediately be supported using the manualpump see section 14 5 Driving blood pump s with the manualpump page 153 Otherwise there might not be sufficient pumpoutput Ikus P 153 4 5
215. 25P 001x01 P30P 001x01 15ml 9 m ag 25ml 99m 326m 30ml 9m P50P 001 PBOP 001 50ml 12m 60ml 12 mm 5 8m L2m 6 8m L2m L20H 002x01 L20H 003x01 PU gt EXCOR lkus lkus
216. 5 5 1 5 1 1 1 2016 6 15B 1 0000087z00000000 7 70522020 XCOR Pediatric gt EXPOR Pedlatrie 2 1 RA i Hr
217. CE To avoid needless kinking of the cannulaeuse a mirror for inspection of the bottom side of the blood pump In no case should the cannulae either be kinked directly at theconnector to the blood pump or at the transition area between velourand silicone EXCOR 8 5 8 5 LV apex cannula 8 5 1 Anastomosis of inflow cannula with LV apex 8 5 1 During anastomosis ofthe LV apex cannula make sure that the cannulahead js facing in the right direction the long side of the head should beparallel to the Iateral wall This prevents the ventricular ateral wall frombeing sucked into the tip of the cannula After the canmula head hasbeen placed its position can be checked by means of
218. a resting period of 6 hours Ikus after each transportationbefore switching 6 Ikus should getadapted to the ambient 8 temperature 14 7 Reading out the LOG files 14 7 Before putting the Ikus into operation RN _ check that the ambient conditionsare a 0 AR suitable see section 15 2 Technical 13 specifications page 163 A ls 9 Keep all driving tube connectors covered at all times when not in use When switching on always take care to switch on the Ikus first and thenthe laptop Never vice versa 14 8 Circuit breaker and battery fuse Always follow the above sequence of operations Always use the keyswitch to switch off the Jkus Do not switch the Ikus off unless the batteries are fully charged To dothis leave the Ikus switched on until all yellow LEDs light up then switchthe Ikus off usin
219. al procedure 6 2 11 Switching from CPB support to VAD support 6 2 1 CPB VAD For further details on regular monitoring of pump s and cannulae seesection 10 5 Regular checks of blood pump s and cannulae page 103 P 103 10 5 Jf no parameter values are entered into the replacement Ikus thereplacement 1kus starts up with he following default Parameter values standard parameters mmHgllefV rightDiastole mmHg lef rightRate bpm Rel diast duration 9 jeft rightOperation mode210 130 40 20 80 40 40 biventricular synchronousand separate Seal the connector s on the Ikus immediately after removing the drivingtube s in order to avoid Ikus kus
220. an be detected lt NumLk gt 1 LED P 45 5 1 5 3 lkus P 67 6 1 3 To connect the blood pump s always set the start up parameters Do not kink either the driving tubes or the cannulae
221. d at temperatures exceeding 30 C Always monitor the charginglevel display see figure 4 3 Display and operating panel page 40 30 Ikus 40 4 3 414 clean Whenever the Ikus is running in battery operation the patient mustalways be accompanied by a perso trained to use the manual pump Thus the patient shall be guaranteed care in an emergency Do not install any other software on this japtop Ikus
222. dequate supply of prematchedstored blood fresh frozen plasma and platelet concentratesavailable for immediate transfusion if required MA Jmplantation anesthesia Keep blood product transfusions to amininnum Blood Transfhsions may lead to the development ofantibodies which are known to promote coagulation and inflammatoryresponse The titanium connectors of the blood Pumps have sharp edgesdesigned to minimise the risk of clot formation at the junction Becareful to avoid cutting yourself while connecting the pump and thecannulae
223. dequate support 436 clean The blood pump may only be replaced under sterile conditions1 When connecting the blood pump s pay attention to the direction afthe arrows on the inflow and outflow stubs These show the direction ofthe blood flow The cable tie covering the EXCOR cannula on the stub of the bloodpump should be removed carefully Important never use a Sharpinstrument for example a scalpel or scissors to remove the cable tie This may cause damage to the cannula EXCOR
224. e I position even if the main switch key switch js in the 0 position Otherwise there is a risk that he drive may fail in future due to the 1Ikusbatteries being totally discharged Aiways follow the above sequence of operations Always use the keyswitch to switch off the Ikus Do not switch the Ikus off umless the batteries are fully charged Leavethe Ikus switched on until all yellow LEDs light up then switch off thelkus with main switch key switch Ikus 0 Ikus Ikus Ikus LED Ikus Ikus 1
225. e If more than 6 systems are in use the number of replacement Ikus hasto be 1 2 of the active systems Ikus Ikus Ikus Ikus 1 2 Ikus Ikus 1 3 4 Ikus Ikus 2 5 6 Ikus Ikus 3 6 lkus Ikus Ikus 4 4 Laptop computer with monitor program 4 4 417 clean When switching on the system make sure that the 1kus is first switchedon and fhen the laptop and not vice versal
226. ean The sizes written in red ink in the pop up menu Select the inflow andoutflow cannula sizes can be chosen However they are not therecommended option for each individual case see section 15 1 10 Pump cannula combinations page 162 and section 15 1 11 Bloodpump combinations in biventricular mode page 162 In individualcases consideration is to be given as to whether a deviant combinationis to be selected The final decision on the combination of bloodpumps and cannulae is to be reached by the implanting surgeon inconsultation with Berlin Heart Inc Clinical Affairs Select the inflow and outflow cannula size P 162 13 1 10 P 162 15 1 11 Berlin Heart
227. er the surface of the product i Do not stick bandages to the cannulae Over time remnants ofadhesive contaminate the cannulae and increase the risk of infection K
228. eriesdischarged use power supply LED 1kus FU Whenever the Ikus is running in battery operation the patient must beaccompanied by a person trained to use the manual pump Thus thepatient shall be guaranteed care in an emergency Ikus To prevent the batteries from aging quickly every period of batteryoperation should be followed
229. escribed here are intended asrecommendations only There is no substitute for careful patientobservation and evaluation by he appropriate medical Personnel s Nn When delivered the Ikus has standard default parameters that it usesafter each complete start up process see section 5 5 1 Routine starttestwhen not in operation page 38 and section 14 3 2 Tkus start testfollowing emergency Dulse mode page 151 However during hewarm up period with the tank unit it is necessary to set the testparameters to prevent the 1kus from generating a false error message Ikus P 58 5 5 1 P 151 14 3 2 Ikus Ikus
230. et count is lt 40 000 pl revert to the Stage 1 heparin dose forcontinuous infusion see Tab 11 1 page 111 2 Platelets lt 20 000 ul discontinue heparin and If the anti factor Xa or PTT is too low or too high during heparintherapy never use a bolus of heparin or protanine Instead increase ordecrease the heparin dose 1U hour as required see Tab 11 1 pagelll 1 40 000uL 1 P ill 11 1 2 20 000 pL HIT Xa PTT IU P Ill 11 1 11 9 Anticoagulation Therapy 11 9 This table assumes the site therapeutic
231. f one pump is not filling and or ejecting completely thepatient must be supported immediately using the manual pump Seesection 14 5 Driving blood pump s with he manual pump page 133 0therwise there is a risk that the patient will not be supportedsufficiently USB USB USB Ikus 1 P 153 14 5 1
232. from environments containingflammable gases and use extreme caution Otherwise there is arisk ofexplosion or gas ignition The Jkus would be severely limited in functionor malfunction altogether as a Tesult of this damage lkus Ikus P 163 15 2 13 2 163
233. g the key switch Ikus 14 8 Ikus lkus LED Ikus lkus The Ikus must always be connected to the power supply when it isswitched on This js the only way to ensure that the start up test isperformed completely and possible malfunctions can be detected Ikus
234. ge 73 lkus Ikus P 73 6 2 10 8 10 Removing the de airing needle 8 10 When removing the de airing needle never pull on the de airing tube but on the de airing needle itself Before removing the de airing needle be sure that the de airing tube issecured to the de airing needle Important Once the de airing needlehas been removed it cannot be re inserted
235. herwise there is a risk of blood pump and cannula leakage Creating a transcutaneous tunnel for the _ 6 LV apex cannula Always usecannula tunnelling tip never use a sharp surgical instrument directlyon the camnula 1f an EXCOR connecting set is reduired for implantation and the lengthof the tube part needs to be reduced the tube part should be cut butony to achieve the following minimum engths Part Number Diameter Reduction Mininnum LengthA1i2 016 16 to 12 mm 90 mmA09 012 12 to 9 mm 75
236. itial starparameters have to be set on the laptop to ensure smooth transitionfrom CPB to VAD support When connecting the blood Pump S to the cannulae always observethe arrows on the inflow and outflow stubs They show the blood flowdirection There js a risk of injury to the patient and severe pumpmalfunction if the ttanium connectors on the end of the inflow andoutflow stubs are not connected to the appropriate cannulae CPB VAD Do not touch or manipulate the blood pumps and cannulae withpointed or sharp edged objects surgical jnstruments Wire brushes etc Ot
237. k of Ikus 10 30 s 412 clean fnctionallimitation and or Ikus malfunction Ikus TF an ambient temperature of 30 C is continuously exceeded duringoperation the lifetime of the batteries is reduced Therefore a persontrained to use the manual pump should always be present in this case This shouid ensure patient care in case of emergency 30 s Use the Ikus as far away as possible
238. ling it through the tunne F 1 ta The incision must be slightly smaller than the cannula diameter toensure good Plan the cannula exit sites appropriately Leave an adequate bridge ofskin and subcutaneous tissue between the cannula exit incisions toprevent breakdown and necrosis of the skin and tissue If possible thecannula exit in sic ions should be on different planes ingrowth but large enough to prevent
239. lmonary edema VAD BVAD 1 1 13 Driving blood pump s with the manual pump 1 1 13 411 clean The use of the manual pump is only permitted for medical personneltrained in the use of it Pay attention to the colored markings on the driving tubes and on theconnectors of the manual pump Otherwise there is a risk of lungedema
240. mend using only water or alcohol to clean the pump and thedrive line IMPORTANT Do not use any corrosive or colored solntions or organicsolvents to clean the blood pump or the drive hne as they may alter thesurface of the product 430 clean Cleaning the cannulae and transcutaneous exit site Do not use anyacetone or petroleum based products near the cannulae and thetranscutaneous exit site We recommend using chlorhexidine to clean the cannulae andtranscutaneous exit site IMPORTANT Do not use any corrosive or colored solutions or organicsolvents to clean the cannulae and the transcutaneous exit site as theymay alt
241. mmHg mmHg bpm 2107 130 40 20 80 40 40 Tab 14 3 6 2 12 Possible complications 6 2 12 Ikus contaminates from entering the system 6 3 Postoperative drive management 6 3 1fthe circuit breaker or internal battery fuse is activated in batteryoperation the 1Kus generates an acoustic alarm Ikus 6 3 1 After transfer to the ward 6 3 1 The Ikus is intended solely for use in a hospital setting Ikus
242. mp s to determine whetherthe pump s are filling and gjecting completely If one pump is notflling and or ejecting completely the patient must be supportedimmediately with the replacement Ikus Use the manual pump whilesecuring the replacement Ikus see section14 4 Connecting the patientto areplacement Ikus page 132 and section 14 3 Driving bloodpump s with the manual pump page 133 resp Otherwise there isthe risk that the patient will not be supported sufficiently 1kus 1 Ikus jkus P 152 14 4 Ikus P 153 14 5
243. ms Ikus 1 1 4 Procedural techniques Ikus 1 1 4 Ikus Follow the numbered instructions exactly in their sequential order Otherwise there is arisk of functional limitation or Ikus malfunction Protect the Ikus unit against dirt and contamination Prevent foreignobjects from falling or working their way into the connectors andventilation slits Keep all drive tube connectors covered at all timeswhen not in use Otherwise there is a risk of functional limitationand or damage Ikus Ikus
244. niVAD Single VAD BVAD 3 388 4 5 PU 6 EXCOR jkus 2 3 2 3 3 lt 4
245. not be adjusted even after he aptop and the monitorprogram have been restarted then the Ikus is operating in emergencypulse mode In this case do not proceed as described here but asdescribed in section 14 3 Emergency pulse mode page 150 instead Ikus P 150 14 3 14 3 150 Ifthe Ikus is operating in emergency Dulse mode the user mustimmediately visually check the blood pump S to determine whetherthe pump s are filling and ejecting completejy If one pump is notfilling and or ejecting completely the patient must be supportedimmediately with the replacement 1kus Use the manual pump whilesecuring he replacement Ikus see section14 4 Connecting the patientto a replacement Ikus page 152 and section 14 5 Driving bloodpump s with the manual pump page 153 resp Otherwise there isthe risk hat
246. nsport crate Otherwise thereis a risk of injury to the transporting persons or of damaging the Ikus 1kus Ikus 10 1kus Ikus 1f it js necessary to transport the patient within the clinic ensure that heis accompanied by a person trained to use the manual Dump Before starting the Ikus make sure that a replacement Ikus is availablein the hospital Ifa replacement kus is not available there is a risk thatthe patient cannot be cared for in the event of device malfunction The general rule is 1 replacement Ikus if 1 or 2 systems are in use 2 replacement Ikus if 3 or 4 systems are in use 3 replacement Ikus if 5 or 6 systems are in us
247. of the operating room 6 1 If the laptop is switched off while the Ikus is in operation the drivingunit will continue to operate using the current parameter settings ikus s For details on commissioning the system see chapter 6 Commissioning the Ikus and setting parameters page 63 P 65 6 Ikus If the adjusted parameter was not confirmed with lt Enter gt theparameter table will display the changed parameter until the automaticlog off but the Ikus will continue operating with the former value The changed parameter display can be Ed with lt Esc gt The originalyalue appears again jn the parameter table lt Enter gt
248. on 6 1 1 Connecting the fank unit page 66 Otherwise thereis a risk that error messages are falsely generated 2 Ikus Ikus P 66 6 1 1 2 After switching on the Ikus pull the key out of the main switch keyswitch and store it in a safe place Ikus
249. orrective action 4 4 Do not kink the drivelines Otherwise there might not be sufficientpump output In no case should the cannulae either be kinked directly at theconnector to the SN blood pump or at fhe transition area gt
250. pm without constantsupervision 60 bpm 1kus 60 bpm 432 clean If the patient does not meet the eligibility criteria at any time during theweaning process Resume pumping at rate prior to any weaning initialrate IR initial rate IR s Oo 12 1 8 Explantation Criteria 12 1 8 ASA and dipyridamole should be discontinued 24 hours prior to deviceexplantation coumadin Enoxaparin should be transitioned back tounfractionated heparin titrated to therapeutic levels ASA 24
251. ration unless this is absolutely necessary e g when moving the patient within the clinic or during a mainsfailure Ikus Whenever the Ikus is running in battery operation the patient mustalways be accompanied by a person trained to use the manual pump 1kus Do not disconnect the 1kus from the mains unless the battery chargeindicator shows that the batteries are full charged all yellow LEDs lightup Important In order to prevent premature discharge and aging ofthe batteries the Ikus should be run in mains operation for at least 6hours after every period of battery operation Ikus LED
252. re Ikus The Ikus power switch toggle switch should always be in he I position even if the main switch key switch is in the 0 position Otherwise there is a risk that the drive may fail in future due to the ikusbatteries being totally discharged Ikus 0 Ikus lt 1 420 clean Do not reconnect the original Ikus to the patient until the Berlin Heart Inc service department has evaluated the LOG files or has serviced thedriving unit Berlin Heart
253. reading out the log files Make sure that you always have the USBstick inserted and that there is sufficient capacity on the stick Otherwise the LOG files might get lost as they are deleted from thehard disk as soon as they have been transferred onto a USB stick USB USB USB USB L 1 5 Packaging and sterilization 1 1 5 EXCOR blood pumps and camnulae are intended for single use only Otherwise there is a risk of infection EXCOR 403 1 E clean
254. rwise there is the riskof pulmonary edema 14 2 Restarting Ikus The crate may only be transported as described jn section 5 7 Transportation and packaging page 60 Do nottilt or overturn the Ikuswhen it is packed inside the transporl crate Otherwise there is a riskthat the 1kus is damaged or destroyed 14 1 3 LVAD BVAD BVAD 14 2 Ikus P 60 3 7 j Ikus Ikus Always observe a resting period of 6 hours after each transportationbefore switching on the Ikus1 The temperature of the Ikus should getadapted to the ambient temperature Ikus 6
255. st fluctuations in relative humidity Do not use blood pumps withdamaged external packaging Otherwise there is a risk that the CBAScoating may be compromised Carmeda BioActive Surface CBAS CBAS The following items are delivered in sterile condition blood pumps cannulae driving tubes de airing set de airing hammer tubeconnecting set membrane set s Ot The external packaging and the outer Surface of the outer sterilepackaging are not sterile These 2 packaging layers must be removedbefore the inner sterile packaging containing the product is handedover to the sterile field Otherwise there is a risk that the sterile field
256. t In children plan to replace the pump s with a larger pump s in good time toprevent the possibility of inadequate support due to an insufficientdischarge rate 13 Error Messages and corrective measures 13 Some errors immediately re trigger an alarm as long as they are stillactive even after being acknowledged on the Japtop Also in this casefirst mute the alarm on the handle in order to prevent permanentretriggering of the acoustic alarm Before acknowledging the alarm waitfor the error message and then take appropriate action Messages are only displayed when the monitor program is running When the monitor program is shut down the only indications thatthere is an error message are an acoustic signal and the fact that theindicator lamp on the Ikus handle lights up There is no way of findingout what type of error message has been displayed
257. t concentrates available for immediatetransfusion if required 9 Keep blood product transfusions to a minimum Blood transfusionsmay lead to the development of antibodies which are known topromote coagulation and inflammatory response x 10 Wound care and treatment 10 Before cleaning the wound see 10 3 Cleaning of the wound page 101 put on sterile disposable gloves cap and mask P 101 10 3 Cleaning the pump and the drive line Do not use any acetone orpetroleum based products near the pump or drivelines We recom
258. tationaryprotective 2 0 a ground via the connector Potential Q equalization The Ikus is designed for stationary 1Ikus operation and to be run on mains Do not Tun it on battery operation unless this js absolutely necessary e g when moving the patient within the clinic or during a mainsfailure i To prevent the batteries from aging quickly every period of batteryoperation should be followed by at least 6 h of mains operation 6 Failure to do like mentioned above will severely reduce the capacity ofthe batteries and will greatly shorten the maximum off mains battery operating time This particularly applies to situations where the Ikus isoperate
259. tepright 1 1 1 6 2 10 Checking the parameters when the pump is started and adjusting them 6 2 10 If the pump is not filling adequately at this stage increase the preloadby adding volume from the CPB circuit Afer adding volume adjust theparameters on the aptop of the Ikus as described in the following table CPB
260. the colored markings on the driving tubes and on theconnectors of the manual pump Otherwise there is a risk of lumgedema AIways keep manual pump attached to the Ikus Otherwise in anemergency Situation the adequate support of the patient js notguaranteed Call one or more persons to assist Otheryise in an emergency Situationthe adequate support of the patient is not guaranteed 5 7 1 Unloading the Ikus from the shipping crate The driving tubes and cannulae should be arranged in a bend freeposition Otherwise in an emergency Situation the adequate support ofthe patient is not guaranteed Ikus 1 5 7 1 Ikus
261. ue to the low volume of air which is moved in 1thepump Therefore in pumps of this size pay special attention to themovement of the membrane and ensure that each pump fills andempties completely 10mL EXCOR Please check left pump and driving tube Please check right pump and driving tube 1 x 12 3 Explantation for BTT 12 3 BTT When planning and timing the transplantation be aware that massiveadhesions may exist in the transplant recipient
262. us on first and then thelaptop and not Vice Versa Ikus Ikus 1 3 Obiigations of the operator s 13 Do not shut down the monitor program unless this is absolutely necessary e g if new user profiles have to be set up Restart the monitorprogran as soon as possible When the monitor program has been shut down the system continues running with the currently set parameters no data on current events are recorded the LOG files will beincomplete an acoustic signal and the indicator light on the handle control panelwill alert the user of new messages However there is no Way todisplay the message that has been detected while the monitorprogram is shut down
263. vided see section 8 2 Use ofthe cannula tunneling tip page 85 to advance the cannula through theprepared transcutaneous tunnel Never use a sharp surgical instrumentdirectly on the cannula P 85 8 2 427 clean Make sure that the bfood pump and cannulae come to rest in a stableposition Without tension Do not touch or manipulate the silicone cannulae with pointed orsharp edged objects e g Surgical instruments
264. willbe contaminated 2 1 1 6 Procedural techniques pumps Cannulae accessories 1 1 6 The preparation and use of blood pumps should only be performed bytrained personnel Surgical nursing and perfusion personnel withoutexperience in the use
265. y Danger of totalshutdown in battery 13 18 Error messages Circuit breaker and internal battery fuse modei 13 19 Electronic malfunction Contact 13 19 customer service Danger of total malfunction of the Ikus in Ikus a the event of an additionalerror Take 6 immediate action 13 22 13 22 Leftright flow sensor defective Notify Service Do not operate the Ikus without Ikus supervision Otherwise an insufficientsupport of the patient might not be dctected In biventricular

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